Dr. Reddy’s Clinical Operations Lead Job – Apply Now!
Looking for a Clinical Operations Lead job at Dr. Reddy’s Laboratories in Hyderabad? Join a leading pharmaceutical company dedicated to innovation in clinical research and biosimilar development. This role offers an opportunity to lead clinical trial execution, vendor management, and strategic planning. If you have expertise in clinical research and operations, apply now!
About Dr. Reddy’s Laboratories
Dr. Reddy’s Laboratories is a leading pharmaceutical company dedicated to improving health and wellness through the development of innovative and high-quality medicines. With a strong focus on research and development, we strive to make a positive impact on patients’ lives worldwide.
Job Description:
Job Posting: Clinical Operations Lead
Location: Hyderabad, Telangana, India
Responsibilities:
- Lead CRO/Vendor Identification, Evaluation, and Selection Process:
- Identify different CROs/Vendors and roll out RFI and RFP
- Assess RFI/RFP information and shortlist CRO for further Comparison discussions with HOD and senior leaders
- Participate in vendor selection visits as Clinical Operations SME.
- Facilitate CRO/Vendor finalization
- Strategic Inputs in the 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 with the sponsor oversight plan by reviewing monitoring reports, CRF data, monthly listings/reports, performing onsite visits, etc.
- Contribute to various functional capability-building initiatives:
- Develop and review various SOPs, Work Instructions, and study manuals
- Consolidate lessons learned and share best practices with cross-functional teams
- End to end vendor management:
- Build and maintain a good working relationship with CRO/Vendor.
- Prepare and conduct F2F meetings with CRO on a 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
Qualifications:
- 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
- Business Understanding: Understanding of biosimilar development, different therapeutic areas, technology platforms, and more
- Behavioral Skills: Ability to work in ambiguity, strong strategic and execution blend, excellent communication skills
Keywords: Clinical Operations Lead, Dr. Reddy’s Laboratories, Clinical trials, Vendor Management, Biosimilar studies, People Management
