One of the world`s leading research-focused healthcare groups in Basel (BS) is looking for an experienced personality with profound knowledge in global study management as
Clinical Research Study Leader
The role of the Clinical Research Study Leader (CRSL) is to provide leadership for one or more global Study Management Teams responsible for delivering internally managed as well as outsourced First in Man through 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 SMT Leader (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. The SMTL is accountable for the delivery of the clinical studies within the agreed timelines, budget and quality
- 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
- Accountable for all aspects of study management including supply management, biosample management, vendor selection and management, site selection, initiation, training, monitoring, essential document management, closedown and archiving in accordance with current Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines
- 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 lifecycle
- Assures consistency and standards across a study or studies for all investigational sites and in line with project standards
- > 5 years experience in study management, with extensive knowledge of planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, sample management, conduct and monitoring of clinical studies
- Life Sciences Degree (BSc, MSc, PhD, MD)
- Experience with global study management and pharma (preferred) or CRO
- Experience in early phase of clinical trials and neuroscience / infection / oncology skills a plus
Please apply online. For further information about the position, please contact your Kelly recruiter, Mr. Andreas Danner, Dr. med. Dipl.-Biol. (+41 44 225 41 07/ +41 76 310 760 9)
We connect people to jobs in ways that enrich lives. Kelly Services® is a leading global provider of human resources solutions, operating in over 40 countries. Together with its subsidiaries, Kelly offers a wide range of outsourcing and consulting services; temporary, permanent and management positions as well as flexible forms of employment at all hierarchy levels. Kelly Services (Schweiz) AG has been present in Switzerland since 1979 and counts more than 200 employees in over 40 Talent Offices and Centers.