Clinical Operations Lead

Lead CRO/Vendor Identification, Evaluation and Selection Process: Identify different CRO/Vendors and roll-out RFI and RFP
Assess RFI/RFP information and shortlist CRO for further Comparisions, discussions with HOD and senior leaders
Participate in vendor selection visits as Clinical Operations SME
Facilitate CRO/Vendor finalization

Strategic Inputs in planning and execution of clinical trials:  Contribute in developing Clinical trial execution strategies/plan and also execute the clinical trials as per Clinical development strategies.
Define various recruitment initiatives in coordination with CRO/vendor.
Contribute in review and finalization of various clinical trial documents/plans like Study Monitoring Plan, project management/communication plan, RACI etc.
Provide clinOps inputs to various study documents viz. protocol, ICF, CRF etc.
Review various project specific Work orders, Change Orders, study invoices etc.
Ensure compliance of sponsor oversight plan by reviewing monitoring reports, CRF data, monthly listings/reports, perform onsite visits etc.

Contribute to various functional capability building initiatives Develop and review various SOPs, Work Instructions, study manuals
Consolidate lessons learnt and share best practices with cross functional teams

End to end vendor management: Build and maintain good working relationship with CRO/Vendor
Prepare and conduct F2F meetings with CRO on need basis

Attend various governance meetings (PTM, CPR, N-CC apex etc.) Participate in various governance meetings like Internal and External Project Team meetings, Data Management calls, CPR, N-CC apex meetings etc and other internal and external governance meetings. 

People Management• Conduct goal setting, performance appraisals and mentoring/coaching for team members.
• Collaborate with HOD in manpower planning, recruitment activities and identifying training needs of team members.
• Provide training to team members on new processes when required

Education 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.) Experience Minimum of 12 years of clinical research/ operations experience of which at least 2 years in Biosimilar studies and 2 years of people management.               Business Understanding: 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 technologies used in execution of Clinical trials (DM, IWRS, safety platforms etc.)               :Negotiations, Cross Cultural sensitivities;
Different Therapeutic Areas (Oncology, Rheumatology, Dermatology etc.) ; Treatment options;
Technology Platforms, Basics of clinical development; Budget forecasting, Global Regulatory framework; Basics of Quality, IP supply and Managment, Vendor relationship management and governance.

Behavioral Skills: Ability to work in ambiguity; Strong Strategic and Execution blend; Ability to align cross functional teams for successful execution; Self-initiative and resilience; Excellent verbal and written communication skills, Good Planning, influencing and negotiation skills.