Senior Manager, Clinical Data Manager

  • Location

    South San Francisco

  • Sector:

    Life Sciences

  • Salary:

    Negotiable

  • Contact:

    Jessica Charles

  • Contact email:

    Jessica.Charles@voltinternational.co.uk

  • Job ref:

    BBBH11011_1660566854

  • Published:

    about 2 months ago

  • Expiry date:

    2022-09-14

  • Consultant:

    ConsultantDrop

Looking for a Senior Manager, Clinical Data Management to join a leading oncology focused clinical-stage drug discovery, development and manufacturing company and be responsible for all aspects of clinical data management activities, manage all CDM components, study budgets and vendor performance to ensure the highest standards of data integrity within the timelines and budget.



Responsibilities

Manage the planning, implementation, and overall direction of executing clinical trial data management activities including protocol review, electronic system configuration, Case Report Form (CRF/eCRF) design, database development, validation programming, and discrepancy management.
Represent data management on study teams, providing accurate study status and timelines, and proactively communicating data management risks.
Manage/oversee EDC database builds including CRF design, edit check specifications, and validation of the clinical database.
Manage/oversee CRF completion guidelines, data management plan, data review plan, and data transfer agreements with vendors (e.g., clinical laboratories, imaging vendors) etc. to ensure a high quality of data and compliance with applicable industry regulations and standards.


Requirements:

BSc life science, computer science or equivalent relevant degree.
Familiar with major EDC systems.
Knowledge of GCP, CDASH/CDISC.
10+ years of experience in Data Management for Pharmaceutical/ biotech/ CRO.
Experience managing CROs is preferred


If this sounds of interest, please reach out to me at 01737 236729 /