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A complete overview for aspiring new entrants into the workforce of the Clinical Research Industry

Clinical Research Industry in India

C A R E E R G U I D E P L AY B O O K

A Note from MMS Online UniversityThis playbook is designed to provide an easy and comprehensive overview of the Clinical Research and the Drug Development Process. It is intended for those who want to pursue a career in the Clinical Research field, as well as the uninitiated who are new to the subject.

In the next pages, you will learn...

• Key factors of the industry

• Relevant students for whom courses in Clinical Research will be helpful

• Job opportunities in various branches of Clinical Research, both at entry level and lateral/higher level positions

• Growth prospects and remuneration prevalent in the industry

Building upon these learnings, suggestions to enhance your own personal competitiveness in the field of Clinical Research will be outlined. The first step in this journey is to learn all there is to know about the industry. Read on for a quick introduction to the fascinating, competitive and highly prestigious industry that is Clinical Research.

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Overview of the Clinical Research Industry in IndiaDescription of Clinical ResearchTo understand the term Clinical Research, it is pertinent to first understand the post discovery process of drug development, beginning with formulation of the drug in the laboratory, through its introduction to the consumer market, and subsequent monitoring of its effectiveness over long periods of time on a mass consumer scale. Each and every step in this process is subject to strict monitoring and ultimate approval from the United States (US) Food and Drug Administration (FDA) in the US or the corresponding relevant Regulatory Authority (RA) in other countries.

The entire process of drug development involves two stages, preclinical and clinical phases.

Preclinical PhaseThere are three major functions of the preclinical phase:

a) The first major function is assessment of safety, toxicity, pharmacokinetics, and metabolism in human beings of New Chemical Entities (NCE) that were discovered through the process of Drug Discovery and which exhibit some significant and promising activity against a particular biological target in a particular disease. It is the function of the drug development process to assess all of these parameters prior to human clinical trials. Furthermore, the Chemistry, Manufacturing and Control (CMC) processes of the drug must be established, that is, the physiochemical properties (chemical constituents, stability, solubility), are scalable to manufacture at large scale, and suitable to dosage form (capsules, tablets, aerosol), intramuscular injectable, subcutaneous injectable or intravenous injectable.

b) The second major function is to recommend the dose and schedule for the first use in a human clinical trial which is also called First Human Dose (FHD). For this purpose, testing is conventionally performed utilizing experimental animals to demonstrate and establish the toxicity levels and adverse effects on metabolism.

c) Submission of an Investigational New Drug (IND) Application for approval to the relevant RA for the NCE to be investigated in the Clinical Phase after establishing the points a) and b).

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Clinical PhaseIn the clinical phase, Clinical Research is undertaken for the purpose of establishing the usability of the drug. Clinical Research should not be confused with Clinical Practice. In Clinical Practice, an established drug is prescribed for a particular type of disease/ ailment. However, in Clinical Research, an investigational drug is tested and its effects studied and evidence collected related to a particular disease/ ailment, with the goal of establishing the drug’s suitability (safety, efficacy) for the treatment of the disease/ ailment.

Clinical Research encompasses different branches of study, such as Clinical Trials, Pharmacovigilance, Clinical Data Management, Regulatory Affairs, Ethics, Medical Writing, etc., and is often conducted at academic medical centers and affiliated research study sites through collaboration between the Sponsors (typically a Pharmaceutical Company), Clinical Research Organizations, and Academic Research Institutions. This network provides access to wider geographic areas and subject demographics, thereby providing a larger number of potential study participants.

Clinical Research involves studies conducted on human beings in four phases, and characteristics of the drug continue to be defined throughout the human clinical trial process. Each phase of the drug approval process may involve more than one distinct clinical trial. The drug development process will normally proceed through all four phases over many years. Phases I, II, and III are typically conducted prior to approval by the RA of the NCE for use in the general population, whereas Phase IV involves ‘post-approval’ studies.

Initial Phase focus is directed toward assessment of safety, for example, evaluating for long-term drug effects such as chronic toxicities, carcinogenicity or adverse effects on fertility, reproduction and immune systems. Once the NCE has proven to have an acceptable toxicity and safety profile, the focus broadens to further demonstrate that it has the desired effect in clinical trials (efficacy trials). Most failures during the drug development process may be attributed to an unacceptable safety profile or a failure to demonstrate the intended effect on the targeted disease in such clinical trials. Successful trials, on the other hand, act as the basis for a portfolio of evidence which is submitted to the RA by the Sponsor for marketing approval in the various countries where the Sponsor intends to sell it. In the US, this submission dossier is called a “new drug application” or NDA. Once the new drug is approved, it is then ready to market.

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The India StoryThe global market for Clinical Trials is 64 billion USD. India’s share is estimated at 15% of the global market, which translates to approximately 9.6 billion USD. The market is growing at an estimated compound annual growth rate of around 14%.

Clinical trial and research is now a major business in India, with over 100 companies currently conducting clinical trials in India. Each year, more than 100 drugs are approved by the Central Drugs Standard Control Organization (CDSCO). This is apart from the Clinical Research and Clinical Trial studies undertaken as ‘outsourced job work’ for international companies.

Medical InfrastructureIndia has a number of government funded medical and pharmaceutical institutions with state of the art facilities, which can serve as ideal sites for multi-centered clinical trials.

Cost CompetitivenessThe cost of conducting trials in India is lower by 50% to 75%, as compared to the US or the European Union. R&D costs in India are substantially less than those in the developed world and it is possible to conduct both new drug discovery research and novel drug delivery system programs at competitive rates. To quote, “Clinical trials cost approximately US $300 to US $350 million abroad, they cost just about INR 100 crore in India which is significantly lower than other countries.”http://archivepharma.expressbpd.com/20051215/ipcspecial05.shtml

Scientific FeasibilityStrong availability of study subjects across major therapeutic segments.

Clinical Research ExpertiseIndia offers an abundant and growing pool of skilled, talented, and experienced medical professionals, and is the second largest English speaking country in the world after the US.

Favorable Regulatory EnvironmentThe Indian regulatory environment allows the conduct of global trials, duty free imports of drugs intended for use in trials, bioequivalence studies for export of data, etc. Compliance with high levels of Good Clinical Practice (GCP) standards as set by the International Council for Harmonisation (ICH) as well as US FDA standards are also followed. Alternate System of MedicineIndia being a land of diversity where Ayurveda, Unani, Siddha, and homeopathy are practiced, clinical studies for evaluation of various alternate systems of medicine may also be conducted.

To summarize, India has been increasingly attracting collaborative contract proposals for conducting clinical trials and many entrepreneurs have already come forward to set up their Clinical Research Organizations (CROs). However, to achieve its goal of becoming a global center of clinical trials, the country has to overcome several primary challenges:

• Multiplicity of Authorities and Lack of Harmonization with Global Regulatory Pathways

• Lack of Regulation Against Fraud

Advantages of Conducting Clinical Research Studies in India

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Take Away for the Clinical Research Career AspirantAs it is well known, the time span of the drug development process is significant, commonly exceeding five years and sometimes even up to ten years. If proficiency is attained in the field of clinical research in any of the various branches of study and trustworthiness of the employer is secured, there may be ample opportunities for job security and good growth prospects. One could move up the ladder in the same organization or move to other organizations at lateral or higher levels, depending upon the skill level, experience, dependability, and responsibility showcased in the working environment. The key factor is mindset of the candidate to inculcate sincerity and integrity and by following GCP coupled with global ethical values. Source: ficci.in/sector/77/Project_docs/ficci-sector-Clinical_Research.pdf

Images for size of industry

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Industry Stakeholders • Pharmaceutical CompaniesMore than 12,000 pharmaceutical manufacturing units are operational in India. Some of the prominent names are Beacon, Glen mark, GSK, Copal, Cedilla, Dr. Reddy’s Laboratories, Torrent Pharma, Sun Pharma, Jubilant Life Sciences, and Ranbaxy Laboratories

• Clinical CROs (Contract Research Organizations) There are more than 65 CROs in India. The prominent names currently in operation are Quintiles, Paraxial, GVK Bio, PPD, Sire Clincher, among others.

• BA/BE Centers (Bio-availability/ Bio-equivalence Study Centers) More than 80 CDSCO approved BA/BE are available in India. Some of the top names are Torrent Pharmaceuticals, Sun Pharmaceuticals Industries, Lupin Bio-Research Centre, Cadila Pharmaceuticals, and Glenmark Pharmaceuticals.

• SMOs (Site Management Organizations) More than 50 SMOs are operational in India. To name a few, Clinicate Research, Ludhiana; ICRS IICRINDIA, Ahmedabad; INVOCON Research Pvt Ltd, Mumbai; Clinsole Clinical Solutions, Hyderabad; Quintessential Solutions, Ahmedabad; and Zenith Clinical Services, Bangalore.

• Data Management CROs In excess of 50 data management CROs operate in India. The top data management CROs are Quintiles, Paraxel, GVK Bio, PPD, and SIro Clinpharm

• IT Companies in Healthcare/Clinical Domain Some of the top IT Companies having a presence in the health care and clinical domains are Accenture, TCS, Wipro, and Cognizant.

• Central LaboratoriesSome example laboratories are Central Drug Testing Laboratories, Chennai, Central Drug Testing Laboratories, Guwahati, Central Drug Laboratories, Kolkata, Central Drug Testing Laboratories, Mumbai, Central Drug Testing Laboratories, Kasauli, Central Drug Testing Laboratories, Hyderabad, Regional Drug Testing Laboratories, Chandigarh

• Training CentersThere are more than 50 training centers in India offering various online, as well as offline training courses in the field of Clinical Research, including ICRI, Apheta Institute of Clinical Research, ACRI India, CliniMinds, Clini India, and ICBio Institute of Clinical Research.

Industry View

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Career GatewayWho can aspire towards a career in the field of Clinical Research?

• MBBS/BDS/BAMS/BHMS etc. Candidates with graduate or post-graduate qualifications in medical and allied health fields such as dentistry, homeopathy, Ayurveda, veterinary science, and pharmacy.

• Pharmacy Candidates: B.Pharm/M.Pharm/Pharm.D

• M.Sc./B.Sc (Life Sciences)Graduate and post-graduate in: biological sciences (e.g. microbiology, biotechnology, botany, zoology), basic science (e.g. chemistry), nursing, physiotherapy, occupational therapy, and social sciences with work experience in clinical research.

• Engineering Graduates (B.E, B.Tech, M.Tech in Biotech)

• Any person with experience working in the health/ pharmaceutical sector.

• Candidates currently engaged in clinical research and related operations, such as members of institutional ethics committees, faculty members and scientists in medical colleges/ institutions, and officials engaged in Clinical Research.

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Career Opportunities Career Opportunities may be classified into those who are seeking entry level positions or those who are seeking lateral or higher level positions. Entry Level PositionsThese positions are generally called the first level / first opportunity to enter the field of Clinical Research

• Clinical Research AssociateClinical Research Associates are the key persons involved in the design, implementation and monitoring of clinical trials. They are required to shoulder the responsibility of planning and implementing all activities required to conduct and monitor complex clinical trials and ensure that Good Clinical Practices are followed throughout the entire process. They also assist in preparation of presentations and manuscripts of scientific meetings and technical journals and attend scientific/professional meetings and training courses as required.

• Clinical Trial AssistantClinical Trial Assistants (CTAs) are mostly hired as support staff. In most cases, CTAs work in administrative positions. Depending on the setting and the trial, some CTAs might also be required to perform basic medical duties such as taking blood or performing lab tests.

• Clinical Research CoordinatorThe Clinical Research Coordinator (CRC) is responsible for conducting clinical trials using Good Clinical Practice under the auspices of the Principal Investigator (PI).

• Regulatory Affairs AssociateResponsible for a) Compiling and maintaining documents for the CTD (Common Technical Dossier), ASEAN CTD & ROW (Rest of the World) regulation and registration documentation databases; b) establishing and maintaining systems for change in documents, reviewing changes in existing products and Standard Operating Procedures (SOPs) to the satisfaction of Regulatory Authorities; c) collecting and coordinating relevant information and preparing documentation for national and international regulatory submissions; d) ensuring timely documentation and evaluation of regulatory compliance of documents performance, or progress reports; process and analyze clinical data including receipt, entry, verification, or filing of information using appropriate statistical tools; write work instruction manuals, data capture guidelines; design and validate clinical databases including designing or testing logic checks; and to coordinate with other departments or outside contractors/vendors to complete validation tasks.

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Career Opportunities Entry Level Positions continued

• Drug Safety Associate Responsible for preparation of safety reports as required by the Regulatory Authorities and the reporting, review and processing of adverse events, supporting the generation of annual safety updates, periodic safety reports and other cumulative safety reports including data retrieval, and quality control. The drug safety associate is required to review clinical trial protocols, bioequivalence study protocols, and to provide inputs to the clinical trial team. They are also responsible for the development and maintenance of effective and efficient safety management plans to assure consistency within the project.Assurance of accurate data entry and quality of data through quality control processes is also a primary responsibility.

• Drug Safety PhysicianResponsible for executing drug safety data management processes: case review; safety and medical assessment; case validation (medical coding, causality assessment, seriousness assessment, safety narrative writing); writing periodic safety reports and aggregate reports, including creation of case listings, label assessment and determination of exposure; and writing PSURs (Periodic Safety Update Reports) and aggregate reports from a medical viewpoint.

• Medical ReviewerResponsible for ensuring that all medical review cases are processed in line with the Standard Operating Procedures and timelines as per the Service Level Agreements.

• Project CoordinatorManages and maintains project documentation which includes nonclinical, manufacturing and clinical information; and provides support to the project team including, but not limited to, setup, filing and maintenance of study file documentation, project tracking and information retrieval.

• Clinical Data CoordinatorA Clinical Data Coordinator’s job is to collect, organize and manage the data collected during the clinical trials in order to help data analysts and the company make better decisions. This involves the collection and management of data such that it may be used to analyze the basic functions of conformity to the specific project and remove redundancies. Coordinators are expected to make sure that the data is collected properly, ensuring that all legal and/or ethical standards are met, especially for data that involves a patient’s personal information. The coordinator works primarily with electronic databases and uses complex software systems to maintain and organize data.

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• Clinical Data Validation ExpertThe role of the Clinical Data Validation Expert is to prepare data analysis listings and activity, performance, or progress reports; process and analyze clinical data including receipt, entry, verification, or filing of information using appropriate statistical tools; write work instruction manuals, data capture guidelines; design and validate clinical databases including designing or testing logic checks; and to coordinate with other departments or outside contractors/vendors to complete validation tasks.

• Data Manager Level 1Data managers are responsible for handling database systems, including the development of policies, ideas, and procedures. They are expected to supervise assistants in data management and (as needed) assign tasks to other employees, supervise data collection systems, manage data entry, ensure data systems are operational, troubleshoot data submission errors, prepare data reports, and oversee general activity involving data.

• Data Entry OperatorA clinical data entry operator is responsible for collecting and precisely sorting and recording information about patients’ medical histories and clinical trials in computerized form. To enable retrieval of such data for further investigation as to the completeness, accuracy and errors, the data entry operator will also be responsible for transcribing and coding information as per the specifications of the employer. Data entry operators are expected to maintain the integrity of the records as they may have access to sensitive patient information.

• Clinical Database ProgrammerResponsible for data programming, data review and data cleaning, Case Report Form (CRF) review, edit checks, data validation, study start up, conduct and close out.

• SAS ProgrammerA SAS Programmer is responsible for providing clinical programming expertise and hands on support to clinical projects across multiple therapeutic areas providing strong technical programming support to data management and contributing to activities in validation.

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• SDTM (Study Data Tabulation Model) ProgrammerSDTM programmers are responsible for end to end SDTM delivery, from creation of specifications and Case Report Form (CRF) annotations, to delivery of Clinical Data Interchange Standards Consortium (CDISC) and SDTM format compliant data sets. The SDTM programmer also interacts directly with clinical data management teams and end customers.

• Lab TechnicianResponsible for cleaning and maintaining laboratory glassware, working with animal colonies, operating laboratory equipment, and keeping the labs functioning on a daily basis.

• Medical WriterResponsible for researching, writing and editing clinical and statistical reports and study protocols, as well as summarizing data from clinical studies for submission to the US FDA and other Regulatory Authorities

Lateral/Higher Level PositionsThese positions may arise out of a shift from a diagnostic center in any other related field, or a shift from entry level positions in one organization to lateral or higher level positions in another organization.

• Project Manager - Data ManagementResponsible for managing data management teams, studies and programs of studies under the general direction of a Sr. Project Manager or Director of Data Management. The Project Manager – Data Management is required to work with other Departments like Clinical Operations, CDMS, Biostatistics, CDS (Clinical Data Services), Medical Writing, Regulatory Affairs and Quality Assurance to ensure that data collected during trials are managed according to corporate standards and meet regulatory guidelines for data integrity.

• Subject Matter ExpertAs the title suggests, a Subject Matter Expert (SME) is a person who has complete authority on a subject. The SME conducts reviews particularly in the area of question development to reduce potential risk in the initial development of a study protocol. The SME is also involved at subsequent phases of the clinical trial, providing guidance and direction for the work done during the clinical trial. SMEs play a significant role in clinical trial oversight and are critical to the success of the entire trial.

Lateral/Higher Level PositionsThese positions may arise out of a shift from a diagnostic center in any other related field, or a shift from entry level positions in one organization to lateral or higher level positions in another organization.

• Project Manager - Data ManagementResponsible for managing data management teams, studies and programs of studies under the general direction of a Sr. Project Manager or Director of Data Management. The Project Manager – Data Management is required to work with other Departments like Clinical Operations, CDMS, Biostatistics, CDS (Clinical Data Services), Medical Writing, Regulatory Affairs and Quality Assurance to ensure that data collected during trials are managed according to corporate standards and meet regulatory guidelines for data integrity.

• Subject Matter ExpertAs the title suggests, a Subject Matter Expert (SME) is a person who has complete authority on a subject. The SME conducts reviews particularly in the area of question development to reduce potential risk in the initial development of a study protocol. The SME is also involved at subsequent phases of the clinical trial, providing guidance and direction for the work done during the clinical trial. SMEs play a significant role in clinical trial oversight and are critical to the success of the entire trial.

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Lateral/Higher Level Positions continued

• Business Development Executive (BDE)BDEs are responsible for facilitating the administration and management of clinical studies to ensure quality and timeliness in the conduct of clinical trials.As the main point of contact between Sponsors and investigators, BDEs establish and maintain key relationships with Sponsor(s) and interface with clinical departments, maintaining an extensive database of investigators in various therapeutic areas, arrange for meetings between the Sponsors and investigators and assist with site feasibility visits. BDEs are also required to assist in the coordination and management of various activities associated with clinical trial planning and initiation, including clinical trial budget and agreement review, third-party vendor identification, and site/study feasibility assessments.

• Clinical Data Programmer/ Senior Clinical Data ProgrammerThe (Senior) Clinical Data Programmer role is either part of the Clinical Data Management Systems (CDMS) group involved in clinical database build or maintenance or the Clinical Data Services (CDS) group involved in clinical data receipt, programming and delivery. The incumbent is responsible for specifying, developing, validating and executing programs and generation of clinical data deliverables. Additionally the (Senior) Clinical Data Programmer is responsible for the quality control of deliverables executed by less experienced programmers, as well as assisting with project management.

• Clinical Data LeadThe Clinical Data Lead is the point of contact for the day to day activity of a study, with key responsibilities for study setup and closeout tasks, as well as overseeing and coordinating tasks delegated to the study team members both locally and in other offices.

• Validation AnalystAssists with validation plans and reports as well as supports the performance of results analysis. Additionally, the Validation Analyst may assist the laboratory with assay validation experiments. Communication with the lead/manager and/or team regarding system testing progress and issues is also required.

• Project ManagerProject managers assist in the planning and execution of clinical trials while adhering to budget, scope and timelines. They are responsible for managing all aspects of a clinical trial or multiple clinical trials, including CRO & vendor selection, adherence to contract and protocol, and ensure data integrity, patient safety, and compliance with appropriate safety regulations.

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• Clinical Trial ManagerPrimary point of contact for clinical operations aspects of designated projects and responsible for developing successful working relationships with clients. The Clinical Trial Manager is responsible for planning, scheduling and implementing the clinical operations aspects of projects. Required to contribute to the development and maintenance of cross functional project management plans and responsible for risk mitigation strategies, associated action plan and issue resolution, and management of the clinical operations project team. Clinical Trial Managers ensure that all necessary project training is provided to assigned staff and provides direction and support to the clinical operations study team.

• Senior Patient RecruiterThe Senior Patient Recruiter is assigned to lead the global patient recruitment function and is responsible for sales, operations, customer management, innovation, business process improvement and people leadership of the Patient Recruitment Specialist (PRS) function. The role requires a broad and comprehensive understanding of theory and practice, as well as modern evidence based methodology of patient recruitment planning and execution of studies conducted by the organization on behalf of its clients.

• Site Management AssociateThe responsibilities of the Site Management Associate include, but are not limited to identifying, training/initiating and closing out study sites; conducting remote site monitoring visits and/or targeted on-site visits as needed; managing study sites and conducting remote site management activities; managing required protocols, amendments and/or deviations; ensuring that data is reported accurately and timelines are maintained.

• Clinical Team LeaderThe Clinical Team Leader (TL) is responsible for providing professional clinical and supervisory services to all persons involved with the research study. The TL provides culturally competent, recovery focused, trauma informed supervision to consumers and staff in their care. Services provided to consumers may include treatment planning, case management, and empathic support. Primary duties focus on: clinical supervision of the trial, and consultation with Recovery House staff, administrative oversight of a multidisciplinary treatment team, program development, as well as providing back up support for the other crisis stabilization team leaders. Providing risk assessments, fee setting for Adult Family Home placements, crisis planning, referrals for on-going care, and documentation are also duties of the TL position. The TL will be under the direct supervision of the clinical team managers within a given trial study unit.

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• Manager Medical & RegulatoryResponsible for ensuring compliance to all regulatory requirements set by the relevant regulatory agency (e.g. Medicines and Healthcare products Regulatory Agency (MHRA)), keeping up to date with changes in regulatory legislation and guidelines, liaising and negotiations with Regulatory Authorities, and ensuring timely submission of all compliance reports. The Manager Medical & Regulatory also provides regulatory expertise to the clinical research team.

• Manager – Safety/PatentsThe Patent Manager will help the inventor organization ensure that it is entitled to the intellectual property rights that prevents others from using its invention in any way for a certain period of time and that there are no other similar inventions that prevent it from receiving a utility, design or plant patent conferred by the Regulatory Authorities all over the world. Will also act as an intermediary between federal or other patent offices and the inventor, ensuring that the patent application is complete and resolving any issues related to the invention. Additionally, The Manager Safety/Patents may also have a role in prosecuting patent violations.

The Safety Manager will help the organization in Safety Trends analysis and adverse event reports for clinical, regulatory and complaint handling submissions, in compliance with worldwide reporting requirements. Managing and Supporting processes including clinical safety monitoring, data collection, queries, reconciliation to support safety reviews, safety support for protocol design; submissions, reports, clinical summaries and updates. Represents Safety during inspection of the company, Train other staff in proper handling of FDA inspections.

• Medical DirectorProvides medical direction for clinical study projects. The Medical Director will be responsible for contributing to the execution of the clinical research programs and will oversee one or more clinical research programs. The incumbent will be in charge of all aspects of patient care services, handle patient complaints, address emergency issues, manage community relations, etc.

• Clinical Research CoordinatorThe Clinical Research Coordinator (CRC) is responsible for conducting clinical trials using Good Clinical Practice under the auspices of the Principal Investigator (PI).

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• Associate Director – ClinicalOversees the operational support for one or more clinical trials being conducted. The Associate Director - Clinical is also required to supervise the activities of other study managers and serve as a liaison with other functional areas. Responsible for the operational planning, feasibility, execution and conduct of clinical trial study

• Associate Director – ProjectsThe Associate Director – Projects drafts project outlines and plans, assigns different tasks to personnel, helps with recruitment of personnel for specific projects, recommends them for appropriate training, keeps track of project delivery and the record of activities. The incumbent is required to possess the skills necessary to solve problems and find solutions related to the projects.

• Director – Business DevelopmentThe Director – Business Development looks after the operations of the organization with respect to business development and is responsible for bringing business to the company. Other responsibilities include problem solving at different levels, contract drafting and the negotiation of business deals for outsourcing clinical trials (if working from the Sponsor side) and obtaining clinical trial contracts (if working from the CRO side). The Director – Business Development is required to have good relations with clinicians who could turn out to be potential investigators.

• Director/Head – Clinical OperationsThe Director/Head – Clinical Operations guides clinical trials of new pharmaceuticals and therapeutic approaches. Responsible for managing all aspects of clinical development and data collection, oversight of adverse event reporting, safety responsibilities, monitoring, adherence to protocols, and determining study completion. The Director of Clinical Operations is also responsible for the development of budgets and works with management when input is necessary. The Director of Clinical Operations has authority over the general management of a medical department’s staff and services.

• General Manager/CEO/PresidentThe General Manager/CEO/President has overall responsibility for the management of the organization and oversees all organizational functions. Responsible for effective planning, delegation, coordination, staffing, organization, and decision making to attain the goals and objectives of the organization.

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• Study CoordinatorThe Study Coordinator is an integral part of the research team and works under the Principal Investigator (PI). Responsible for conducting studies in accordance with federal and hospital regulations and, depending upon organizational requirements, the Study Coordinator may also have responsibility for budget negotiation, monthly invoicing, account management, and regulatory paperwork. Prepares for study initiation, obtaining physician signatures, recruiting subjects, screening and scheduling subjects, obtaining voluntary subject consent, teaching subjects about protocol expectations for them, performs study/protocol procedures in a detailed, accurate manner, and maintains study files.

• Principal InvestigatorThe Principal Investigator (PI) is responsible for the management and integrity of the design, conduct and reporting of the clinical trial project and for managing, monitoring, and ensuring the integrity of all collaborative relationships. The PI is the primary individual responsible for recruitment of staff to conduct the study, patient recruitment, obtaining informed consent, conducting the trial study in adherence with all regulatory stipulations, GCP and ethical values, in addition to institutional policy governing the conduct of the sponsored research.

• Co-Principal Investigator or Co-InvestigatorThe Co-Principal Investigator or Co-Investigator (Co-PI or Co-I) is a key study team member with responsibilities similar to that of the Principal Investigator. While the PI has ultimate responsibility for the conduct of a research project, the Co-PI/Co- I is also obliged to ensure that the project is conducted in compliance with applicable laws and regulations and institutional policy governing the conduct of the sponsored research.

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• Quality Assurance ManagerQuality Assurance (QA) Managers are responsible for the clinical quality assurance functions of the organization, ensuring planning, coordination, control, and continuous improvement of processes and methods to control the quality of studies conducted. The QA Manager’s focus is on continuous improvement using approved tools, design control, validations, and ensuring adherence to relevant regulations and industry guidelines, for the conduct of clinical trials. This work involves close interaction with clinical operations, information technology, and other supporting areas and development teams to help ensure their active participation in continuous quality improvement activities.

• Statistical ProgrammerStatistical Programmers are typically members of a biostatistics team and play a prominent role in all SAS programming tasks required for clinical trial analysis and reporting. Required to work in close collaboration with other members of the data management department, Statistical Programmers are responsible for developing SAS macros, templates, and utilities for data cleaning and reporting, communicating with the internal team to create deliverables for pharmaceutical and biotechnology clients, and work with the project statistician to implement analyses specified in the protocol or the Statistical Analysis Plan (SAP).

• StatisticianA statistician is responsible for evaluating, analyzing and interpreting clinical data. Along with researchers, statisticians evaluate best way to collect and query data, define specifications for analyzing and summarizing data, review output for accuracy and quality, and interpret the results in accordance with methods used. Medical statisticians are a position to interpret research findings with the help of supporting evidence which they are able to gather from their experience of analyzing the data.

• Data ReviewerData Reviewers are responsible for the review of clinical trial data in accordance with global data management plans and applicable standardized data management processes; the identification of erroneous, missing, incomplete or implausible data; and run ancillary programs used to support the review of clinical trial data. Data Reviewers assist with the development of data management plans and quality management plans that will deliver accurate, timely and consistent quality clinical data, and may also assist in the development of clinical data model and database design.

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• Quality Assurance ManagerQuality Assurance (QA) Managers are responsible for the clinical quality assurance functions of the organization, ensuring planning, coordination, control, and continuous improvement of processes and methods to control the quality of studies conducted. The QA Manager’s focus is on continuous improvement using approved tools, design control, validations, and ensuring adherence to relevant regulations and industry guidelines, for the conduct of clinical trials. This work involves close interaction with clinical operations, information technology, and other supporting areas and development teams to help ensure their active participation in continuous quality improvement activities.

• Database DesignerThe Database Designer works in close association with the IT department and focuses primarily on the programming aspect of database design, analyzing data inquiry needs, ensuring security of information, and organizing the layout to present the information needed in the best form. In addition Database Designers may also be required to take over some of the responsibilities of database administrators and maintain data backup, storage and data integrity.

• Senior Medical WriterSenior Medical Writers are responsible for researching, writing, and editing clinical/statistical reports and study protocols, and summarizing data from clinical studies for submission to the US FDA and other Regulatory Authorities. In order to write such reports, a Senior Medical Writer obtains data and technical information from study team members and other relevant parties and arranges it in accordance with Regulatory Authority and international conventions to produce one or more components of the submission dossier or related documents.

• Head – Data ManagementResponsible for creating and enforcing policies; ensuring the adequacy, accuracy, and legitimacy of data; and all other aspects requisite for the efficient and secure implementation of all data management functions. The Head – Data Management is also required to ensure adherence to legal standards and protect digital databases and archives from security breaches and data loss.

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• Medical MonitorMedical Monitors are accountable for safety across the study; provide medical expertise to the study team during key activities; review study level data including GCP issue reports; address safety issues across the study; coordinate, review and approve key documents such as protocol and clinical study reports; and play a key role in interactions with Regulatory Authorities.

• Quality Assurance ExecutiveThe Quality Assurance (QA) Executive is responsible for ensuring that all clinical processes are conducted in accordance with stipulated guidelines and regulations. QA Executives are required to develop, perform, and manage all aspects of quality assurance activities and are expected to preside over audits.

• Regulatory Affairs AssociateResponsible for a) Compiling and maintaining documents for the CTD (Common Technical Dossier), ASEAN CTD & ROW (Rest of the World) regulation and registration documentation databases; b) establishing and maintaining systems for change in documents, reviewing changes in existing products and Standard Operating Procedures (SOPs) to the satisfaction of Regulatory Authorities; c) collecting and coordinating relevant information and preparing documentation for national and international regulatory submissions; d) ensuring timely documentation and evaluation of regulatory compliance of documents performance, or progress reports; process and analyze clinical data including receipt, entry, verification, or filing of information using appropriate statistical tools; write work instruction manuals, data capture guidelines; design and validate clinical databases including designing or testing logic checks; and to coordinate • with other departments or outside contractors/vendors to complete validation tasks.

Source: http://careers.iconplc.com/

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Remunerative Career Depending upon basic qualifications and the type of training undertaken, candidates may be placed in any of the above mentioned positions. The compensation package standards for different demographics in the Clinical Research field are outlined below.

Entry Level PositionsSalaries in entry level positions are expected to range from Rs.2.5 lakhs to Rs.3.5 lakhs per annum (p.a.).

Lateral Positions Depending upon the position held at the time of shift and the salary drawn at that time, salaries may be negotiated keeping the previous data as the base level. The estimated range can be anywhere between Rs.3.00 lakhs p.a. to 6.00 lakhs p.a., up to Rs.8.00 lakh p.a. in some specialized fields. Outliers in every layer and organizations can always exist depending upon the individual talents and skills of the candidate. Leadership Positions in Clinical ResearchNot specifically defined. As the positions are few in number, remuneration will be decided on a case to case basis with mutual understanding and discussion amongst the concerned parties. Generally, these packages will as per competitive industry standards and comparable to similar positions in allied fields.

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Building competitiveness to work in CR fields1. If you are a potential new entrant, determine if you like the field of Clinical Research and if you would like to make a career out of it. If you are already in the field, explore your options evaluate the positions and verticals you would like to reach in this particular field.

2. Understand and evaluate your skill gap. The first thing required is to get certified by a credible and prestigious Training company with hands on experience in the field of conducting parts or whole of Clinical Research activities. Such a Certification course will give you the launch pad from where you can initiate and accelerate your career in the field of Clinical Research.

3. Never stop learning. Put in additional effort by continuous reading, deeply analyzing and understanding of the latest trends in the field. Deep and up to date knowledge will bring in growth opportunities and compensation increase. The major advantage of this field is the job lasting factor as each project or assignment is very long. Expertise will give you a better positioning among your peers for demand for your services and subsequent employment opportunities.

4. Visit ‘www.mmsuniversity.com’ today to take your first step towards a long fulfilling career in Clinical Research Industry.

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Frequently Asked Questions

1. What is the credibility of this assessment-based certificate program?MMS is a reputable, global CRO with subject matter experts teaching the course and evaluating the assessments. A assessment-based certificate program demonstrates your credibility in having understood the course content thoroughly enough to be able to apply it in a practical setting.

2. What are the advantages of acquiring this certificate?Compared to commonly offered courses with simply attendance criteria, the advantage of an assessment-based certificate program is your readiness to immediately apply what you have learned in the actual field of work. If you are new to the industry or seeking a career change you can emphasize this aspect to your potential employer.

3. What is the payment policy?The payment for each course is required at course initiation, after registration and prior to beginning of the first class. The mode of payment and course fees are detailed within each course during the registration process.

4. What if I don’t pass? Will I be allowed to retake the test?This is an assessment based certificate program and your understanding and completion of the assessment is required for the certificate. In the event you score below the minimal credentialing requirements you will be allowed to retake the course and testing one additional time at no extra charge.

5. What time or duration is allowed for each course?Course durations and other prerequisites or requirements are outlined in the course descriptions.

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