Clinical Trial Manager

Position Clinical Trial Manager (CTM) Responsibilities Oversee end-to-end study operations at country level to meet timelines, budget, and quality. Act as country primary point of contact for internal/external stakeholders; ensure clear communication and coordination. Lead country/site feasibility and proposal/validation of country study targets. Plan and execute start-up timelines/activities with local study team, GTAC, and stakeholders. Implement patient recruitment strategy and risk mitigation; ensure enrolment targets/timelines. Lead issue/risk resolution, including contingencies and appropriate escalation. Set up local vendors during start-up; participate in investigator meetings. Ensure CTMS data is current/complete; ensure eDC/eTMF/eTMF access; upload documents in eTMF. Validate study materials (protocol, ICF, patient materials) and support document reviews/prep. Support Site Initiation Visits/Investigator Site Assessment Visits; verify eTMF completeness. Acknowledge monitor visit reports, act within timelines, and document/escalate issues. Coordinate database locks and query follow-up; ensure timelines. Ensure inspection readiness; support Health Authority inspections. Coordinate CAPA for country audit findings. Coordinate local study team meetings; support GTAC with invoice queries/patient compensation claims (if applicable). Support site relationship management (including CRO issues), possible site closure, and serve as point of contact for sites. Prepare/support Health Authority and Ethics Committee submissions and follow-up to approval (as required). Support approvals for closure of funds/POs; update national registries (if applicable). Coordinate resources on evolving country regulatory requirements with Regulatory/Legal. Competencies/Skills GCP, ICH guidelines, and local clinical research regulations/codes of practice. Clinical research processes, regulations, methodology; understanding of medical settings and medical records management. Strong planning/organizational skills; independent decision-making. Communication skills (oral/written) influencing others; English and local language. Proficient independently in Microsoft Suite, CTMS, eDC, eTMF. Qualifications Bachelor’s or Master’s in life sciences or equivalent. Minimum 4 years industry experience. Experience leading/participating in cross-functional teams and initiatives. Occasional local travel Benefits (as listed) Health coverage (medical/pharmacy/dental/vision), wellbeing support (including EAP), financial protection (401(k), disability, life/accident insurance, legal support, survivor support), and paid time off programs. #J-18808-Ljbffr