Clinical Trial Manager

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Job Title:

• Clinical Trial Manager

Department:

• Regional Clinical Operations

Purpose/Objective: The Clinical Trial Manager is responsible for the oversight and delivery management of clinical trials at the country level, ensuring timely, budget-conscious, and high-quality execution from start-up to closure. This role serves as the primary point of contact for both internal and external stakeholders at the country level.

Key Responsibilities:

• Coordinate cross-functional teams within the country, acting as the main point of contact with the protocol manager and global study team members.
• Collaborate with internal roles in the country and manage the site feasibility process, including proposing and validating country study targets.
• Develop and implement a country-level patient recruitment strategy and risk mitigation plan, ensuring study enrollment targets and timelines are met.
• Lead problem-solving and resolution efforts, including risk management, issue resolution, and appropriate escalation.
• Assess and set up local vendors during the study start-up period.
• Participate in and prepare for Investigator Meetings.
• Ensure that data in Clinical Trial Management Systems is current and complete and that access to eDC and vendor systems is available for country and clinical trial site personnel.
• Validate study-related materials, including protocols, Informed Consent Forms (ICF), and patient materials.
• Prepare country-specific documents, such as global country-specific amendments.
• Prepare materials for Site Initiation Visits (SIVs).
• Verify and confirm eTMF completeness at the country and site levels with the local team.
• Review Site Monitoring visit reports, take action within specified timelines, and escalate issues as necessary, ensuring proper documentation.
• Coordinate database locks and query follow-up, ensuring adherence to timelines.
• Ensure inspection readiness for assigned trials within the country, providing support for Health Authority inspections and pre-inspection activities.
• Coordinate, develop, and implement Corrective Actions/Preventive Actions (CAPA) for country-level audit findings, driving review, implementation, and completion.
• Lead local study team meetings.
• Review and approve payments (based on GOA) and manage patient compensation claims, if applicable.
• Manage site relationships, including addressing CRO-related issues.
• May conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs).
• May perform site closure activities, including post-closeout.
• May act as the point of contact for sites.
• May support the preparation and submission of documents to obtain approval from local Health Authorities, Ethics Committees, and other relevant bodies.

Senior Level Expectations:

• Engage with the Global Trial Manager, line management, and/or Head of Clinical Operations to assist in resolving complex issues locally and/or globally.
• Serve as a key resource for colleagues by providing guidance, leading training, and mentoring other team members through both informal and formal presentations.
• May be assigned as a Lead Clinical Trial Manager for a study locally, as determined by leadership.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
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