Clinical Trial Manager
DOCS
United Kingdom
5d ago

Job Summary

If you have the required profile for this role and are open to a fixed term contract opportunity, please send your CV to Alison.

burton docsglobal.com and to arrange a confidential chat.

Roles & Responsibilities of the position

In this role you will manage studies start-up through close-out activities assuring that IIS study progress, safety reporting, drug and financial management adheres to the contract and all applicable Policies, SOPs, Work Instructions and regulatory requirements.

  • Acts as the central contact for designated project communications, correspondence and associated documentation for assigned IISs.
  • Primary point of contact for Sponsor-Investigator and staff during all phases - Monitors study progress and initiates corrective and preventative actions -
  • Ensures that contracts, budgets and payment schedules are prepared in accordance with IIS contract requirements - Ensures that required safety information (e.

    g. SAEs / NSAEs, PQCs) are reported and processed according to all applicable SOPs / WIs. - Budget oversight for assigned IISs including forecasting.

  • Establish and maintains excellent working relationships with external stakeholders
  • Job Requirements

  • Degree in health sciences, Nursing or related scientific field is preferred.- At least 5 years clinical research operations experience in the pharmaceutical industry or CRO;
  • Experience in managing investigator initiated studies - Solid understanding of the drug development process including ICH / GCP and local regulatory requirements.
  • Strong leadership skills - Ability to work on multiple IISs in different therapeutic areas is required.- Clinical research operational knowledge and project planning / management -
  • Willingness to travel occasionally with potential overnight stays

    Remuneration & other details

    Competitive basic salary, plus car allowance and great benefits package.

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