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 Commencement Date
Why study this program?
Clinical Trial Management is a widely used term in the clinical research industry. This term is self-explanatory i.e. it is the management of clinical trials. A successful clinical trial happens when it is managed by an expert team of professionals who are equipped with imperative skills and knowledge in project management. For most of the professionals, clinical trial management refers to a software tool with which a trial is managed and trial progress assessed. But, there exists copious in clinical trial management beyond this.
It is believed that the project manager set the standards for successful conduct of the clinical trial which were followed by the clinical trial workflow. The current clinical research industry is facing challenges in identifying competent staff for project management with obligatory skills and knowledge. Hence there is an imperative need for trained and adept personnel for clinical trial management in the industry.
James Lind Institute offers Post Graduate Diploma in Clinical Trial Management (PDCTM) which prepares a student with the required skillset and knowledge for successful clinical trial management. The students are provided with the methodological approach for understanding the core concepts of clinical trials and their management thus enhancing their skills and knowledge to the level expected of a Clinical Research Project Manager.
The curriculum for the program - Post Graduate Diploma in Clinical Trial Management (PDCTM) is extensive, has been developed and evaluated by experienced industry professionals and is fully endorsed by the clinical research industry. Not only is this program suitable for new graduates but also for working professionals who either wish to grow further in their clinical research career, or those who wish to make a move to the clinical research industry from any other related sector.
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?
Course assessment involves online multiple choice questions for each lecture, followed by assignments for each study module.
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?
Throughout the course, the students can interact with the faculty and other students via the e-Campus to discuss any coursework related issues.
Each student enrolled in the Professional Diploma in Clinical Trial Management Course (PD-CTM) is also assigned a mentor throughout the course who will be a senior professional from the industry. Towards the end of the program you will be provided placement assistance if required and career development support via the “Student Success Team”.
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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.