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Clinical Study Lead Phase I

  • Location:

    Mechelen

  • Contact:

    Nele Daems

  • Job type:

    Contract

  • Contact phone:

    0032 15858038

  • Industry:

    Biotechnology

  • Contact email:

    nele_daems@oxfordcorp.com

Do you have extensive experience in managing Phase I trials, is this what you really like and want to continue doing ?  Then check out the job below, it just might be for you !

Job Description

Supporting the Development team in contributing to the clinical evaluation of new drug candidates through the operational management, and timely execution and delivery of clinical studies.

Responsibilities

  • Appropriately plan allocated stud(y)/(ies) in terms of budget, resources and timelines.
  • Execute and deliver on allocated clinical stud(y)/(ies) from initial planning, setup and conduct until final reporting of results within agreed budget, timelines and with high quality.
  • Initiate and coordinate the vendor selection process.
  • Be the primary contact person for selected vendors and ensure high quality oversight of performance in accordance with agreed study plans, timelines & budget.
  • Build a sound relationship with the key vendor and site staff in charge of the execution of allocated stud(y)/(ies).
  • Develop the Clinical Study Oversight Plan and ensure that oversight activities are performed and documented accordingly.
  • Monitor budget/timelines and provide accurate forecasting
  • Monitor quality and progress of allocated stud(y)/(ies) versus agreed quality standards, budget and timelines. Flag variances to COPL and direct line management.
  • Report status of allocated stud(y)/(ies) as required.
  • Coordinate the timely creation of, review and/or approve study documents and plans.
  • Ensure proper and timely set-up, maintenance, review (i.e. Quality checks) and archiving of the Trial Master File.
  • Internal primary point of contact for assigned clinical stud(y)/(ies), close interaction with Clinical Study Team (CST) members.
  • Build sound cross-functional relationships with relevant staff from the Project Team (PT), Clinical Development Team (CDT) and with all CST members.
  • Organize and lead cross-functional Internal CST-Meetings and prepare, attend and follow-up on vendor meetings.
  • Ad hoc, act as CST representative in the CDT.
  • Interact with the Quality Monitor and follow-up on audit reports. Ensure timely creation of CAPA-plan and timely CAPA closure.
  • Comply with the client's procedures and processes, ICH-GCP and applicable regulations and guidelines.
  • Actively initiate and participate in Process Improvement initiatives.
  • Participate in/present at team and departmental meetings
  • Participate in/present at Committee meetings (Protocol Review Committee (PRC), Management Review Committee (MRC), Development Management Committee (DMC)), as required.
  • Specific accountabilities for Early Development studies:
    • Act as representative for Clinical Operations in the joint PT/CDT when relevant for the set-up of a study concept of an Early Development study.
    • Take part and provide operational input in Focused Clinical Team meetings where details on the study design of an Early Development study are being discussed.
    • Ensure a budget and timelines are allocated to a newly planned Early Development study in the client's project management system as required.

Requirements

  • You have obtained a Master’s degree or a PhD in life sciences.
  • Willingness to travel
  • You have a good understanding of drug development as well as a solid experience in clinical study management.
  • Experience in selection, contracting and maintaining overview of vendors is an asset
  • You really enjoy working in cross functional teams.
  • You have excellent oral and written communication skills in English