4 - 6 Months (Self Paced)
Maximum Allowed Duration: 18 Months
Expected Effort: 10-15 hours/week
This program will provide you with a methodical understanding of the core areas of clinical research and impart extensive training in clinical trial management to groom you to become an effective project manager.
TOTAL CREDITS: 20
Next Start Date
Why study this program?
Clinical trials provide evidence of a drug’s safety and efficacy. They are the key for a new chemical entity to enter the pharmacy shelves. A well designed and perfectly managed clinical trial conduct goes a long way in achieving this objective faster and more efficiently. An expert team of clinical trial management is imperative to review the scientific question in place, available literature, development and design of clinical trial protocol, budgeting of clinical trials, designing of data collection instruments and in many other crucial areas.
A global survey has revealed that about half of the clinical trials being conducted worldwide, change their objectives and goals of the study during the study because of poor clinical trial management. The report also says that most of the failures are because of practical problems associated with the trial management and not because of scientific issues. Thus, a trained clinical trial manager or a team of clinical trial management is crucial for successful clinical trial conduct.
Through this program we offer a platform by which you can become fully equipped with the imperative skills of clinical trial management. The Professional Diploma in Clinical Trial Management (PDCTM) program will provide you with a methodical understanding of the core areas of clinical trial management thus enhancing your skills and knowledge to the level expected of a Clinical Trial Project Manager. It imparts extensive training in clinical trial management to groom you to become an effective project manager.
What will be taught?
MODULE 01: GENERAL INTRODUCTION
MODULE 02: BASICS OF DRUG DEVELOPMENT
MODULE 03: ETHICS IN CLINICAL RESEARCH
MODULE 04: ROLES & RESPONSIBILITIES
MODULE 05: ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
MODULE 06: STUDY START-UP
MODULE 07: CLINICAL TRIAL MONITORING
MODULE 08: COMPLIANCE AND AUDITS
MODULE 09: DATA MANAGEMENT AND BIOSTATISTICS
MODULE 10: REGULATORY AFFAIRS IN CLINICAL RESEARCH
MODULE 11: PROJECT MANAGEMENT - Based on Project Management Body of Knowledge
MODULE 12: CLINICAL PROJECT MANAGEMENT OVERVIEW
TOTAL CREDITS: 20
MODE OF STUDY: ONLINE
The Professional Diploma in Clinical Trial Management (PDCTM) course curriculum is fully reviewed and endorsed by the Clinical Research Industry. This program is suitable both for new graduates as well as professionals working in clinical research who wish to soar higher in the management hierarchy.
How will I be assessed?
You will be assessed on an ongoing basis by the faculty based on the following criteria:
One is the completion of the online multiple choice question tests that follow each lesson; and second is the timely submission of assignments for each study module within the JLI e-Campus.
Your academic performance in the program will be assessed on a 4 point GPA scale. More details about our evaluation system is available in the following link: Evaluation System
Am I eligible?
The minimum eligibility criteria for the course would include either of the following:
- Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
- Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc
- Any degree in Pharmacy / Pharmaceutical Sciences
- Any degree in Chemistry / Biostatistics / Bioinformatics
- Any degree in Nursing / Allied Health.
- Students in their final year of graduation for the above courses are also eligible to apply.
If you lack the above mentioned educational prerequisite you may still be eligible to apply if you have some prior work experience in clinical research in positions such as CRA, CRC, CTM etc. Please contact our admission representatives / counsellor to discuss your case.
What support will I receive?
As a student you can interact online with the faculty members and fellow students to network and to discuss important topics via your e-Campus. The faculty promptly answers all questions related to the study in the Online Campus Tutoring Center (OCTC).
Towards the end of the program you will be provided placement assistance if required and career development support via the “Student Success Team”.
In addition, each participant registered in the Professional Diploma in Clinical Trial Management is provided with a mentor who is an experienced professional from the clinical research industry. The mentor can be contacted at any time via email or phone.
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James Lind Institute offers various masters degree programs in the areas of public health, business administration etc.
- MPH (with specializations)
- M.Sc in Health Mgmt
- MBA (various specializations)
For information on available masters programs via our School of Health Sciences; & our Business School click below:
Clinical trial management is more than just reviewing and analysing reports generated by various clinical trial management systems. Clinical trial managers need to have a keen sense of anticipating potential problems and take necessary measures to ensure that the project deliverables are not impacted.