Main contact person to support country study team to communicate with global PTDS, local PT or third party vendor to ensure proper management of clinical supply from order to destruction in accordance with ICH-GCP, local GCP, GMP, Roche SOPs, regulations and requirements. Provide user requirement specification to local PT for third party vendor selection, evaluation and inspection, if apply.
Main Accountabilities and Responsibilities:
Clinical Supply Management
- Support country study team to coordinate local PT and global PTDS to ensure a smooth clinical study medication importation as per study timeline. Track and document goods receipt status at local depot.
- Ensure that sensitive, potential unblinding, IMP documentation that is required by local customs for importation purposes is not shared with the Local Study Teams in CCO China, nor investigational site staff. Also ensure that these documents are not archived in a location that is accessible by local CCO study teams.
- Coordinate with local PT and country study team to make sure the clinical study medication to be dispatched to the clinical study site per request. Track and document dispatch information.
- Support country study team to purchase the commercial drug for clinical study use and coordinate with local PT to conduct additional labeling upon request within required timeline.
- Support country study team to coordinate with local PT in additional labeling of use-by date extension for clinical study medication upon request within required timeline.
- Support country study team to coordinate with local PT to arrange and track the destruction of clinical study medication returned from study site and/or stored at local depot upon the authorization from related stakeholder.
- Provide country study team with monthly clinical study medication inventory report for country study team to monitor the clinical study medication inventory.
- Coordinate with local PT and country study team for clinical service cost payment. Submit purchasing requisition to local PT for purchasing packing material used for clinical study medication transportation.
- Support supply of clinical study related equipment, such as thermometers to the study site as per country study team’s request and ensure thermometer calibration.
- Provide support for importation of clinical study used materials (like lab kit, pad, booklet, etc).
- Work with local PT to review and provide inputs to clinical supply related local SOPs before approval in Condor system. Deliver related training to targeted people to ensure proper implementation.
- SAP key user from PDG CCO China, to liaise with local IT to solve local SAP issue if required and provide related training to new SAP user if applicable.
Clinical Supply Third Party Vendor Management (if applicable)
- Work with third party vendor to manage the supply of commercial drug used in clinical trials and purchased outside of SRPL to meet with country study team’s requirements. Provide the feedback for third party vendor’s performance and compliance.
- Provide user requirement specification to local quality team for their evaluation of third party vendor qualification and performance at regular basis.
- College degree or equivalent or above, majored in medicine/pharmacy/science related is preferred
- Experience in Clinical Research/Development or related industry (appreciated).
- GCP/GMP knowledge on clinical supply management
Skills, Experience and Competencies:
- Decision Making — identifies and understands problems and opportunities by gathering, analyzing and interpreting quantitative and qualitative information; choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions; taking action that is consistent with available facts and constraints, and optimizes probable consequences.
- Customer Orientation — places a high priority on the internal or external customer’s perspective when making decisions and taking action; implements service practices that meet the customer’s and own organization’s needs.
- Technical/Professional Knowledge and Skills has achieved a satisfactory level of technical, functional and/or professional skill or knowledge in position-related areas; keeps up with current developments and trends in areas of expertise; leverages expert knowledge to accomplish results.