Looking for an opportunity to put your clinical project management skills to the test? We are seeking an experienced Clinical Project Manager to join our team at Gouya Insights GmbH & Co KG, a clinical development consulting and clinical research services company supporting innovative biotech, pharmaceutical, and medical device companies. As Clinical Project Manager, you will take operational ownership of early-phase clinical studies and development projects, working at the interface between our clients, clinical sites, CROs, specialist vendors, and internal clinical development experts. You will translate clinical development strategies into operational execution, coordinate cross-functional project teams, and ensure timely delivery of projects within budget constraints, maintaining high quality and GCP standards. This role suits a proactive leader who enjoys taking ownership, working in a dynamic early-development environment, and solving the operational challenges that arise when multiple partners need to work together. Key Responsibilities
Clinical Trial Management Lead the operational delivery of assigned clinical studies from planning and start-up through study execution, database lock, and close-out. Develop and manage study plans, timelines, budgets, deliverables, and risk-mitigation activities. Lead regulatory activities to ensure timely approvals and keep site activation on schedule. Coordinate site feasibility, selection, activation, enrollment, study conduct, and close-out activities. Act as a central operational interface between clients, sites, CROs, vendors, and cross‑functional experts. Track critical‑path activities and proactively identify, elevate, and resolve operational risks, issues, and dependencies. Coordinate cross‑functional activities with Medical Experts and Medical Writers, Clinical Data Management, Biostatistics, Pharmacovigilance, and Quality. Maintain effective project governance, including project, risk, and action trackers, status reporting, and project meetings. Support clinical trial budget management, forecasting, accruals, and change control. Lead the selection, coordination, and oversight of CROs and specialist clinical trial vendors and support their contracting and qualification. Review scopes of work, proposals, budgets, assumptions, invoices, and change orders and identify potential gaps or budget risks. Ensure clear responsibilities, interfaces, timelines, deliverables, and escalation pathways across external partners. Monitor CRO and vendor performance against agreed scope, quality, timelines, and budgets. Manage interfaces and dependencies between vendors, ensuring that outsourced activities remain appropriately controlled and aligned with sponsor oversight responsibilities. c. Client & Stakeholder Management
Act as a key operational contact for assigned clients, providing transparent reporting on project status, timelines, budget, risks, and required decisions. Build strong working relationships with clients while providing constructive solutions and operational recommendations, rather than simply escalating problems. Lead project meetings and ensure decisions, actions, responsibilities, and timelines are clearly documented and followed through. d. Quality & Compliance
Ensure studies are conducted in accordance with ICH‑GCP, applicable regulations, SOPs, and study‑specific requirements. Maintain inspection‑ready clinical trial and sponsor oversight documentation. Partner with Quality on audits, CAPAs, deviations, quality issues, and continuous improvement. Contribute to the improvement of Gouya Insights' Quality Management System, operations processes, and management practices. What You Bring to the Table
Advanced degree in life sciences, natural sciences, or medicine, with at least 3 years of relevant clinical research experience, including clinical project management or substantial operational responsibility for clinical trials. Other relevant combinations of education and experience will be considered. Ability to work independently, prioritize competing activities, and take the lead in a dynamic environment. Hands‑on experience in clinical trial start‑up and conduct; early‑phase, first‑in‑human, Phase I or Phase II experience is highly desirable. Experience managing CROs, clinical sites, and specialist vendors. Strong knowledge of ICH‑GCP and applicable EU and/or US clinical research requirements. Understanding of sponsor oversight responsibilities and outsourced clinical trial activities. Strong project management, organizational, and problem‑solving skills with a proactive and solution‑oriented mindset. Ability to identify operational risks, unclear responsibilities, and missing interfaces before they affect study execution. Strong stakeholder and client management skills and the ability to coordinate multidisciplinary teams. Strong skills in MS Office, data visualization, and presentation. Familiarity with clinical trial systems such as EDC, eTMF, and CTMS. Excellent written and spoken English. Knowledge of German and other languages would be an advantage. A Bit About Us…
Founded in 2016, Gouya Insights is a clinical development consulting and clinical research services company dedicated to supporting innovative drug and medical device development. We work with biotech companies, start‑ups, pharmaceutical companies, and medical device manufacturers to translate clinical development strategies into executable clinical programs and studies. Our expertise spans clinical and regulatory strategy, study design and scientific advice, clinical operations, CRO and vendor oversight, study conduct, and medical writing. A particular strength of Gouya Insights is our ability to operate at the interface between clinical development strategy and execution. We coordinate sponsors, investigators, sites, CROs, specialist vendors, and clinical experts to deliver operationally feasible, high‑quality clinical studies. Our international team combines scientific and clinical development expertise with hands‑on operational execution, helping our clients move innovative products from development strategy into clinical evidence.
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