Senior Clinical Outsourcing Manager @ Danaher

Job Information

Job Description:

The team is responsible for:

  • Providing clinical and scientific knowledge and expertise.
  • Providing strategic direction to support timely development and execution of the clinical program.
  • Externally lead scientific discussions with regulatory agencies, investigators, and external experts.
  • Partnering cross functionally to provide and collect critical input for evidence generation to support regulatory submissions, clinical evaluations and overall evidence and support across all business areas and across the product lifecycle.
  • Lead pre-market medical activities to ensure successful launch.

In this role, you will have the opportunity to:

  • Representing Radiometer in clinical study planning, study design, study execution, site management and study closeout about utilizing CROs.
  • Negotiates CRO contracts and budgets and follow keenly up on CRO deliverables and deadlines.
  • Head up yearly MSA negotiations with preferred partners.
  • Responsible for study level RFI, RFP, Bid Defense meetings and SOW contracts.
  • Ensuring efficient collaboration with the CRO Clinical Research Associate – CRA – ensuring that the CRO CRA take responsibility for the successful management of the site right through to close-out, in accordance with the clinical monitoring plan.
  • Ensuring that the CRO CRA develop effective relationships with investigator site staff to ensure that key clinical metrics are met.
  • Ensuring that the CRO CRA secure the integrity of clinical data through an ability to sufficiently maintain site tracking records and working diligently to relevant guidelines.
  • Proactively identify clinical project risks, provide input to appropriate countermeasures and contingency plans, and assure implementation of action plans to reduce project risk.
  • Use the Danaher Business System and standard work to systematically measure/report/improve the overall clinical study process.
  • Participate in project teams as the representative from Clinical Affairs and daily proactively lead study execution with the Clinical Study Managers.
  • Maintain current knowledge and ensures adherence to Good Clinical Practice (GCP), global standards, and department standard operating procedures for conducting clinical studies

The essential requirements of the job include:

  • +5 years of experience in successful proactive Outsourcing Manager in a regulated environment and holds a Master of Science (M.S.) in a scientific, biological or medical science field.
  • Strong negotiator of contracts with a track record of successful contract negotiations.
  • Thorough experience of study budgeting with relevant external stakeholders from the clinical environment as well as internal key stakeholders from management, Legal, QA and Finance.
  • Demonstrated a strong track record of successful results and in leading collaboration in effective teams and getting work done through others.
  • Demonstrated strong ability to understand complex scientific, engineering, and business concepts.

Benefits:
Experience Level: Senior
Work From: Onsite

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