Employer description & source details
Lead the planning, execution, monitoring, and completion of assigned clinical research projects, ensuring project objectives and deliverables are achieved. Coordinate cross-functional project teams to ensure activities comply with applicable regulations, industry guidelines, corporate policies, and quality standards. Oversee project operations, budgets, regulatory requirements, and patient safety to maintain operational and financial integrity throughout the project life cycle. Manage the development, maintenance, and appropriate disposal of essential clinical study documents, data, equipment, and tools, including protocols, SOPs, informed consent forms, and case report forms (CRFs). Assign, track, and oversee interdisciplinary activities, including site monitoring, database development, data collection, adverse event management, statistical analysis, and clinical study reporting. Serve as the primary point of contact for sponsors and clients, proactively managing expectations, resolving project-related issues, and maintaining effective communication. Organize and facilitate project meetings, prepare investigator updates, and provide regular project progress and status reports to relevant stakeholders. Support site and patient recruitment strategies, stakeholder training initiatives, and the development of study-related communication materials. Participate in regulatory submissions, audits, third-party vendor selection, and other activities required to support successful project delivery. Monitor team performance, project milestones, and deliverable quality to ensure alignment with sponsor expectations, project requirements, and regulatory standards. Bachelor's degree in a relevant field, preferably Health Sciences, Clinical Research, or a related discipline. 1–3 years
Extracted skills: operations, project management