This is a great job opening for a Clinical Research Study Leader to join a global healthcare company based in Basel, Switzerland. With over 80,000 employees, this is an exciting opportunity to join one of the leading organisations in the world. Reporting to the Study Lead Team Lead, the role of the CR Study Leader is to provide leadership for multiple global Study Management Teams responsible for delivering internally managed as well as outsourced First in Man thru Proof of Concept studies. The CRSL is accountable for the strategic and tactical study activities, ensuring high quality execution standards within the agreed budget and timelines.
- Leads the cross-functional Study Management Team (SMT). In the SMTL role, the CRSL is responsible for the planning, coordination, communication, motivation and setting the direction of the SMT, including obtaining agreement on study required timelines, budgets, objectives and goal-setting
- Prepares and manages the budget/financial plan including overall study and site-level costs, collaborating with the respective stakeholders in contract negotiations and preparation, payment schedule and tracking
- Identifies key milestones and tracks critical study activities, issues and strategic priorities. Provides regular updates as appropriate, to key stakeholders.
- With SMT partners, ensures the development of study protocols in conjunction with SMT members, case report forms (CRFs) with Data Management, and necessary regulatory documentation following the provision of clear objectives.
- Conducts protocol and site feasibility assessments to ensure optimal site selection
- Accountable for all aspects of study management including supply management, biosample management, vendor selection and management, site initiation, training, monitoring, essential document management, closedown and archiving in accordance with current Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines
- Manages both internal and external partners
- For outsourced studies, contributes to CRO selection activities and contract set-up, serves as primary contact with CRO PM and provides oversight of CRO, ensures communication between CRO, other vendors and SMT for the entire study
- CRSLII may provide support and mentoring to other CRSLs
Skills and Requirements:
- Life sciences degree or nursing equivalent or substantial experience in a clinical research/a healthcare environment
- Over 10 years of clinical development experience in a global environment, leading the operational aspects of all stages of complex early phase clinical studies
- Extensive experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, sample management, conduct and monitoring of clinical studies (with preference for early phase studies)
- Sound understanding and appreciation of the scientific basis for different study types, ability to question scientific rationale and practical aspects of protocol design and to act as an equal partner for scientific team members.
- Capability representing the Study Management Group at Clinical Teams.
- Proactive management of risk mitigation strategies to troubleshoot foreseeable consequences to a variety of decisions made by a team or an individual
- Direct experience overseeing multiple vendors and sites
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call James Mackinnon on +41 (0) 615 881 152 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.