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Life Sciences / Data Support Tech (Life Sciences Grad) - VR/23679

Status: Permanent
Location: Aberdeen
Ref: VR/23679
Rate: Available Upon Request

We are currently looking for a Life Sciences graduate (recent, or with subsequent career experience) for a permanent / staff opportunity with an exciting company.

    

Job Purpose:

To support the Data Vendor Management and Biostatistics groups in cross-vendor oversight in the provision of clinical trial services for vendors working on clinical trials worldwide.

To undertake responsibilities as defined in Operating Procedures, Core Policies and Quality Policy.

      

Accountabilities:

Primary Responsibilities:

  • Undertakes delegated vendor support oversight activities in compliance with relevant laws, regulations and guidelines and with policies
  • Supports the management of designated vendor contracts in accordance with Quality Management System (QMS) requirements
  • Supports the Data vendor Management and Biostatistics officer in completion of assigned oversight tasks
  • Supports the coordination and review of study documentation as required
  • Produces and reviews the following weekly vendor oversight reports:

Laboratory kit shipment reports

Pharmacokinetic samples pending shipment from Central Labs

Cancelled laboratory tests

Laboratory kit inventory at sites

  • Responds to queries from vendors regarding:

Laboratory samples

MRI and PET scans

Pharmacokinetic samples

  • Tracks Amyloid-PET scans received by vendor, escalating pending scans on a monthly basis
  • Reviews MRI/PET Query reports and escalating queries where applicable
  • Supports the oversight of data reconciliation processes during the life cycle of a study (including generation and maintenance of Reconciliation Plans for delegated Data Vendors)
  • Management of vendor data reconciliation timelines, in the lead up to database lock
  • Attends Data Vendor Management and Biostatistics Calls
  • Oversees the vendor implementation of updates to Clinical Site Set Up Trackers, to ensure site activation timelines are met.
  • Complies with the requirements of a Trial Master File (TMF)
  • Supports with the QC checking of the TMF and SOF.
  • Conducts all job-related activities according to the QMS and relevant regulatory and guideline requirements
  • May be required to deputise for the Data Vendor Officer for specific allocated tasks

     

Education, Experience and Skills:

Education:

  • BSc (Hons) in Life Science desirable
  • MSc, PhD or equivalent desirable

     

Experience:

  • Knowledge Neurodegenerative disease are desirable
  • Previous Project Management experience desirable

     

Skills/Knowledge:

  • Awareness of Good Clinical Proactive (training will be provided)
  • Excellent organisational and communication skills
  • Project Management Training
  • Ability to read, understand and follow company policies and SOPs

TMM Recruitment

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