Project Lead

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