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