Clinical Trial Operations Manager
hace 6 días
Clinical Trial Manager – Sponsor Dedicated
The Clinical Trial Manager provides regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. This role leads the Study Management Team (SMT) and ensures regional/global clinical operations deliverables progress according to agreed-upon timelines and milestones, including country & site feasibility and site selection, trial set-up, trial execution, and trial closure, as well as vendor set-up activities assigned by the Global Clinical Development Operations Trial Leader (GTL).
Key Responsibilities:
• Ensure compliance with applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), and local regulatory requirements.
• Manage timely and accurate documentation and communication of trial progress.
• Ensure the Study Management Team (SMT) operates in a constant state of inspection-readiness.
• Act as primary contact for Country and Regional staff.
• Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress.
• Participate in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits.
• Contribute to patient understanding of protocol and patient safety by contributing to the review of country-specific informed consent in accordance with procedural document/templates.
Essential Requirements:
- BA/BS degree in a health or science-related field.
- 1 to 8 years of clinical trial management experience in the pharmaceutical industry or CRO.
- Superior clinical research operational knowledge and proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure.
- Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols, and associated protocol-specific procedures.
- Strong IT skills in appropriate software and company systems.
- Effective leadership skills and ability to manage multiple stakeholders.
- Proficient in speaking and writing the country language and English.
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