Job Title
A highly organized and detail-oriented Clinical Research Manager is required to lead the operational planning, execution, and oversight of company-sponsored clinical trials.
In this pivotal role, you will be responsible for managing the set-up, conduct, supervision, and termination/abortion of internally approved company-sponsored clinical trials.
* The ideal candidate will have excellent project management skills and experience in coordinating and managing clinical trial operations.
* Responsibilities include:
1. Managing the assigned trial(s) in accordance with budget, timelines, and quality as well as regulatory compliance of projects (GCP guidelines, regulations, and applicable SOPs).
2. Providing trial-related operational input to the CRD Project Development Team with respect to the defined deliverables.
3. Setting up, monitoring, and adapting the trial-specific cost plan.
4. Assigning and monitoring trial-specific trainings of the Trial Operations Team members, including the documented handover of tasks to new team members.
5. Coordinating the writing and revision of trial-specific documents, e.g., Protocol (and amendments), Patient Information / Informed Consent, CRF, Investigator's Brochure, as well as plans and manuals as defined in the Trial Management Plan.
6. Ensuring the handover of trial documents required for regulatory submissions to internal Regulatory Affairs or to assigned CRO, or conducts regulatory submissions, as defined in the trial-specific RACI and according to outsourcing strategy.
7. Conducting and monitoring submission to ethics committees or ensuring handover of trial documents to assigned CRO, as applicable, as defined in the trial-specific RACI, in accordance with outsourcing strategy and contracts with clinical trial sites.
8. Collaborating with the Project Lead, Subject Matter Experts (such as Clinical Trial Supplies Manager, Clinical Data Manager, Biostatistician etc.) and the Manager Clinical Operations, proposing the outsourcing strategy to the decision committee.
9. Implementing contracts with vendors and conducting oversight with respect to quality, time, and budget deliverables.
10. Monitoring the workload and performance of the internal Trial Operations Team.
11. Developing effective relationships with clinical trial sites and vendors.
12. Planning and participating in trial-specific meetings, e.g., Project Meetings, Trial Execution Team Meetings, Expert Meetings, Investigator Meetings, Vendor Meetings.
13. Ensuring effective handling of trial-related issues, their escalation if required, their reporting as required, and their closure, according to processes.
14. Implementing trial-specific risk handling in terms of identification, mitigation, and review to ensure high-quality and timely delivery of set goals.
15. Implementing issue resolution and lessons learned together with the Operational Trial Team members and other relevant SMEs.
16. Performing co-monitoring visits if necessary.