Life Sciences / Data Support Tech (Life Sciences Grad) - VR/23679
We are currently looking for a Life Sciences graduate (recent, or with subsequent career experience) for a permanent / staff opportunity with an exciting company.
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.
- 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:
MRI and PET scans
- 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:
- BSc (Hons) in Life Science desirable
- MSc, PhD or equivalent desirable
- Knowledge Neurodegenerative disease are desirable
- Previous Project Management experience desirable
- 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
Receive information on the latest job opportunities by email. Subscribing to our job alert service is convenient and easy.Sign Up Now
Great recruitment is all about the people you work with. We take the work we do for you, not ourselves, really seriously.Our Team