Job Description
- Vendor/CRO Selection and Management - Ability to execute the process of identification and facilitation in finalization of different CRO/Vendors
- Strategic Inputs in planning and execution of clinical trials
- Contribute in developing Clinical trial execution strategies/plan
- Execute the clinical trials as per Clinical trial execution strategies/plan
- Contribute to various functional capability building initiatives.
- Forecast and Manage project budget
Mandatory Skills
- Understanding of biosimilar development
- Awareness about regulatory guidance's for the conduct of clinicals trials in India and other regulatory agencies
- Knowledge on Biosimilar Competitive Intelligence; Reasonable knowledge on Technolgies used in execution of Clinical trials (DM, IWRS, safety platforms etc.)
- Demonstrates problem solving skills
- Excellent verbal and written communication skills
Qualifications
Master /Bachelor Degree in life sciences or allied medical fields (e.g., B. Pharm./M. Sc. (Life science)/ M. Pharm./M.B.B.S./Ph.D.)
Additional Information
- Basics of clinical development and different Therapeutic Areas (Oncology, Rheumatology, Dermatology etc.) ;
- Global Regulatory framework; Basics of Quality, IP supply and Managment, Vendor relationship management and governance
- Ability to work in ambiguity
- Strong Strategic and Execution blend;
- Good Planning, influencing and negotiation skills;
- Proven project management experience in healthcare, clinical research, or contract research organisation
