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Field based Director Of Clinical Operations

Field based Director Of Clinical Operations

  • Location

    Germany

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    benefits package

  • Contact:

    Angel Gaskin

  • Contact email:

    Angel.Gaskin@volt.eu.com

  • Job ref:

    73919TOP-PHARM-AGK_1584630317

  • Published:

    2 months ago

  • Expiry date:

    2020-04-18

  • Start date:

    April 2020

  • Consultant:

    #

I am currently working with a Bio pharmaceutical specialising in Rare Diseases who are looking for a Director Of Clinical Operations.

Job Duties & Responsibilities


Ensure overall quality and compliance of local site management and monitoring conducted by external CRAs

Ensure appropriate oversight of monitoring

Proactively identify, manage, escalate, resolve and mitigate study issues at a site level

Maintain a thorough knowledge of disease area and protocols

Conduct training with CRO CRAs and study site staff as required

Conduct feasibility assessment and make recommendations for site selection

Ensure execution of and adherence to monitoring plan

Ensure regulatory compliance & GCP adherence by monitors and site personnel

Ensure accurate and reconciled drug accountability at local level

Ensure appropriate Investigator Site File documentation filed for each study site assigned