ROCGJP00015574 working period 25/05/2022 bis 22/05/2023
For our customer a major player in the Pharmaceutical Industry in Basel we are looking for a
Clinical Research Study Leader
The role of the Clinical Research Study Leader 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.
The perfect candidate is someone with solid experience in global study management (on a leading level), ideally with experience of early phases, someone with effective leadership skills still able and happy to do operational work. Please note that there will be operational work involved; please ensure your candidates are aware about it. If that helps, we are looking for someone between a GSM & a GSL in terms of level of experience.
On a personality level, as always we need collaborative, open-minded people, willing to learn, develop and grow. We need someone used to matrix environment and flat hierarchy settings.
Tasks & Responsibilities:
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.
- Minimum 7/8 years in study management with extensive experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, sample management, conduct and monitoring of clinical studies
- Minimum Bachelor (preference on Master) in Life Sciences
- Experience with global study management
- Experience in pharma (preferred) or CRO
- Effective leadership skills, able to lead cross-functional teams across multiple time zones
- Experience working in matrix environment and flat hierarchical team setting
Nice to haves:
- Experience with early phases of clinical trials
- NS & Infection & Oncology
- Start date: ASAP
- End date: 1 year
- Extension: possible
- Work location: Basel
- Workload: 100%
- Remote/Home Office: Onsite work will be required. Details to be discussed in interviews and when in contract.
- Travelling: No travel
- Team: about 15 people
Please apply online. For further information about the position, please contact your Kelly recruiter, Franck Maerky (+41 61 270 80 17).