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Job Details

3rd Party Clinical Data Project Manager

Company: MSI Group Limited
Location: Slough UK
Reference: VR-7772
Closing Date: 06 Jan 18
Type: Contract
Salary (£): Competitive

Job Summary:

Contract role - pharmaceuticals


A globally recognized pharma company are actively searching for a 3rd Party Clinical Data Project Manager who has oversight of the timely and quality clinical trials data deliverables from CRO Partners and 3rd party vendors per agreed Quality Performance and Key Performance Indicators.


Key Responsibilities:

  • Integrating and processing data loads from various sources into the clinical and operational data repositories including the project management of planned deliverable and study timelines
  • Oversee the creation and maintenance of databases and relevant technology or file share including Clinical Data repository and other relevant technology or file share.
  • Complete ad-hoc analyses of CDISC SDTM data. Creating, modifying and updating programs or database structure for the management of data requiring medical coding, including the management of transfer or exchange of medical coding data to and from a partner, vendor or CRO and uploading to applicable tools
  • Programming reports and visualisations for clinical operational data.
  • Review of critical document/deliverable (SDTM Annotation, SDTM datasets) to ensure that applicable data standards including project-specific standards are used consistently and support creation of DE dataset
  • Perform relevant quality checks and create standard edit checks for new CRF modules as well as perform and document processes adhering to all applicable regional regulations such as Good Clinical Practice, and Good Clinical Data Management Practice.
  • Support audits and inspections and other responsibilities and projects as assigned


Skills Requirements:

  • Strong skill set in managing different stakeholders internally and externally
  • Great communicator and ability to develop and improve on built-on relationships with the ability to  influence and motivate
  • Substantial experience in the clinical, CRO or pharmaceutical industry. in clinical trial data-related processes such as the review of CDISC SDTM annotated CRFs, writing and reviewing technical specifications, review of SAS/R/etc. log files for errors and warnings, resolving and troubleshooting errors, and clinical data mapping and CDISC SDTM Controlled Terminology
  • Relational database design, SAS programming, SQL and PL/SQL programming experience as well as Clinical Data Management. Relational databases, preferably Clinical and Operational Data Management Systems like CDMS, CTMS.
  • Familiarity with reporting, visualisation and BI tools. Building project timelines. Computer system validation, in particular 21 CFR part 11.


Apply for this job: 3rd Party Clinical Data Project Manager

Contact Information:

Address:  Head Office
3rd Floor East, Cottons Centre, 47/49 Hays Lane London SE1 2QE
Tel:  02079401985
Fax:  02079909763
Website:  Visit Our Web Site

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