Beschreibung
Clinical Research Study Leader (m/w/d) - Pharma / Planning / SOPs /GCPProject / Role:
For our Pharma client in Basel we are looking for a highly motivated and qualified Clinical Research Study Leader (m/w/d).
Background:
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. Perfect Candidate: 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.
Must Haves:
- 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
Reference No.: 920766SKN
Role: Clinical Research Study Leader
Industry: Pharma
Location: Basel
Workload: 100%
Start: ASAP
Duration: 12++
Deadline: 26.10.2021
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.
Contact us for further information regarding our company, our positions or our attractive payroll-only-program: .
About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.