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Regional Clinical Trial Manager
hace 2 meses
Job Summary:
Clinical Trial Manager – Sponsor Dedicated.
This role provides for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. The successful candidate will lead the Study Management Team (SMT) and ensure 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 and vendor set up activities as assigned by the Global Clinical Development Operations Trial Leader (GTL).
Key Responsibilities:
- Ensure services rendered adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements.
- Ensure availability of required reports to support real-time tracking of trial status according to trial plan.
- Manage timely and accurate documentation and communication of trial progress.
- Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness.
- Act as primary contact for Country and Regional staff.
- Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
- Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits. Escalates corrective and preventive actions (CAPA) to GTL MAO and CPL when the trial deviates from plans and communicates study progress and issues to study management teams and business partners.
- Contributes to patient understanding of protocol and patient safety by contributing to the review of country-specific informed consent in accordance with procedural document/templates. This includes reviewing and managing site-specific informed consent forms in accordance with SOPs, other procedural documents, and applicable regulations.
Requirements:
- Bachelor's 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. 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. Willingness to travel with occasional overnight stay away from home according to business needs.
- Effective leadership skills and ability to manage multiple stakeholders.
- Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate.
