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Global Clinical Project Lead Fresher's job

9 months ago   Medical & Healthcare   Hyderabad   32 views Reference: 28450
Job Details
  1. 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
      Paricipate in vendor selection visits as Clinical Operations SME
      Facilitate CRO/Vendor finalization
  2. Planning and execution of clinical trials -
  3. Execute the clinical trials as per Clinical development startegies, review and finalization of various clinical trial documents/plans and Ensure compliance of sponsor oversight plan
    • Give strategic inputs and Define various recruitment initiatives
    • Provide clinOps inputs to various study documents and review
    • Reviewing KPIs / KRIs, monitoring reports, CRF data, monthly listings/reports,
  4. Functional capability building -
    • Develop and review various SOPs, Work Instructions, study manuals and share best practices with cross functional teams
  5. Ensure overall adequacy of conduct, data quality, compliance and adherence to timelines for their assigned trial(s)
    • Ensure all aspects of study site management i.e. recruitment of qualified investigators, site initiations, conduct investigator meetings, ensure enrollment criteria are met and other aspects of the study management as appropriate.
  6. Vendor management and People Management
    • CRO/Vendor relations, Collaborate with HOD in manpower planning, recruitment activities and identifying training needs
  7. Attend various governance meetings (PTM, CPR, N-CC apex etc.)
    • Participate in internal and external governance meetings.

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Company Description
We are committed to providing access to affordable and innovative medicines, driven by our purpose of Good Health Cant Wait.Our products and services are spread across our core businesses of Active Pharmaceutical Ingredients (API), generics, branded generics, biosimilars and over-the-counter pharmaceutical products around the world. We work towards meeting unmet patients needs in the areas of gastro-enterology, cardiovascular, diabetology, oncology, pain management and dermatology. We are investing in businesses of the future including drug discovery, clinically-differentiated assets and digital healthcare.