About the job
We are seeking a dedicated Clinical Trial Manager or Senior Clinical Trial Manager to take the lead in planning, conducting, and overseeing the operational aspects of clinical studies. You will ensure that all clinical trials are executed according to the established protocols, standard operating procedures (SOPs), ICH-GCP guidelines, and applicable regulatory requirements.
Key Responsibilities:
- Act as the primary clinical contact for clients.
- Work collaboratively with project managers on monthly invoicing and clinical budget variance management.
- Create and maintain study-related clinical documents, including clinical plans, informed consent form templates, study-specific forms, manuals, CRF completion guidelines, study trackers, PSV/SIV slides, and other training materials.
- Identify and address training needs for Clinical Research Associates (CRAs) and third-party vendors, including presentations at investigator meetings and study kick-off sessions.
- Generate a list of potential sites from key stakeholders and lead the site feasibility process.
- Assess risks to enrollment targets based on feasibility analysis and site commitments.
- Devise and finalize recruitment and retention strategies for each country involved in the study.
- Establish effective communication and relationships with investigators and the study team to facilitate feasibility, site start-up, enrollment, maintenance, and close-out procedures.
- Lead internal clinical team meetings, setting clear expectations for CRAs and Clinical Trial Assistants (CTAs).
- Respond to all CRA and site inquiries while maintaining a Frequently Asked Questions (FAQ) log as necessary.
- Assist in planning and conducting investigator meetings.
- Review and approve investigational product release packages.
- Oversee and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in collaboration with regulatory departments as required.
- Develop clinical monitoring strategies to ensure study timelines and quality deliverables are met.
- Utilize metric reporting tools (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to confirm compliance with study plans and communicate issues to project managers and CRAs as needed.
- Manage the implementation and oversight of the electronic Trial Master File (eTMF).