Clinical Study Manager

Job description :

Clinical Project Manager

1. Proactively manages clinical trials from start-up to closure with a focus on trial timelines, quality, budget, and vendor oversight.

2. Leads selection of CRO and vendors including identification of potential vendors, RFP process, qualification of vendors where required and contract negotiation.

3. Supports preparation of regulatory dossier by providing documents and required information

4. Leads the study start-up process, including, but not limited to, preparation of the trial kick-off meeting, study documents, plans and manuals, set-up of the trial master file (TMF), and site feasibility process (where applicable).

5. Collaborates with the Clinical Trial Supply Management function to ensure an effective procurement and supply strategy for study medication, with no stockouts during trial and low overage at study end.

6. Oversees CRO and vendors during the trial to ensure compliance with project requirements, internal processes, timelines, budget, ICH GCP, and local and international laws.

7. Monitors the quality of vendor deliverables, addresses quality issues with the appropriate team members and identifies opportunities to improve training, execution and quality control.

8. Oversees monitoring of clinical trials, ensuring high-quality trial execution at sites, identification of deviations and implementation of mitigation strategies as required.

9. Ensures study is at all times inspection ready.

10. Provides efficient updates on trial progress to Head of Clinical Operations and Senior Management.

11. Ensures trials are registered in trial registries (as applicable) and accuracy of trial information and that updates and final reporting are submitted on time.

12. Ensures timely shipment and tracking of lab samples to ensure no loss of samples due to lack of operational oversight and availability for timely analysis for study reporting.

13. Ensures risk management plans and contingency plans are available for assigned trials and escalates key study risks to the attention of the Head of Clinical Operations / Senior Management. 14. Reviews and approves vendor invoices in collaboration with the Development Finance Specialist / Finance department personnel to ensure vendor payments occur in a timely manner

15. Supports vendor and site audits, follows up on audit findings to ensure appropriate responses and CAPAs implemented by vendors and sites.

16. Ensures all project-level study documentation is filed in the TMF in accordance with applicable SOPs, guidance documents and regulatory requirements and provides oversight to the CRO team regarding TMF filing, maintenance and archival procedures.

17. Supports preparation of responses to queries from Regulatory, Marketing or any other molecule related queries.

18. Ensures at study end that eTMF is completed and archived, budget reconciled, lab samples and IMP samples retained or discarded as per internal decisions.

19. Supports SOP development and review, participates in internal process improvement activities and other activities as needed.