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Clinical Data Standards Manager

Berkshire   •  Contract/Temporary, Full time


CK Clinical are recruiting for a Clinical Data Standards Manager to join a pharmaceutical company at their site based in Slough on a contract basis for 12 months.
Company:
This company is a successful global biopharmaceutical company that discovers and develops innovative medicines and solutions for people living with severe diseases of the immune or central nervous systems. The company works across approximately 40 countries across Europe and the rest of the world.

Location:
This Clinical Data standards Manager position will be based at our clients UK Head Office in Slough, Berkshire. It is 20 miles west of London and has easy access by car from both the M4 and M25. The offices are also accessible by public transport (bus and train).

Clinical Data Standards Manager Role:
The main purpose of the role will be to:

  • Execute on client clinical data collection standards strategy. The scope of standards includes, but is not limited to:
    • Data transfer specifications
    • eCRF and other data collection methods e.g. eSource, ePRO
    • Forms
    • Controlled terminologies
    • Instructions
    • Edit checks
    • SDTM datasets
    • SDTM mappings

  • Develop, update, and decommission clinical data standards using metadata repository software in collaboration with the Data Collection DST.
  • Provide QC on standards developed by colleagues.
  • Make appropriate containers of metadata repository available for study level builds.
  • Ensure adherence to company (clinical) data standards by reviewing/approving CRF and data collection development by CRO Partners.
  • Create and maintain the Clinical Outcome Assessment Repository (COAR); related SharePoint Sites; etc. to ensure consistent information regarding the company standards is readily available to applicable stakeholders esp. CRO partners.
  • Act as point of contact for (clinical) data standards maintenance when needed.

Your Background:
Experience required:

  • 3/4 years of experience in the CRO/pharmaceutical industry working in the area of clinical data standards.
  • 5+ years of experience in a multicultural and global pharmaceutical environment.
  • Advanced use of MS Office suite of products and Adobe Writer.
  • Comprehensive knowledge of Good Clinical Practices and international regulations.
  • Experience managing global cross-functional groups effectively in order to reach consensus.

Specific skills:

  • Knowledge of the CDISC suite of standards, esp. SDTM, controlled terminology, ADaM, etc.
  • Knowledge and understanding of proven and accepted standards development processes.
  • Proven project management, time management, and organizational skills.

Apply:
For more information or to apply for this Clinical Data Standards Manager position, please contact CK Group, quoting job ref 49267.

It is essential that applicants hold entitlement to work in the UK.


You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Stephen Lord
  • Phone: 01246 457722
  • Reference: 49267
  • Posted: 17th November 2020
  • Expires: 15th December 2020

CK Group

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