For our client OM Pharma specialized in biotechnology, localized in the Geneva, we are looking for a :
Clinical Trial Manager
- Planning and feasibility assessments of clinical trials
- Operational excellence in ICH-GCP compliant execution of global clinical trials including management of budget and timelines as well as delivery of quality.
- External service provider / vendor management for clinical trial execution
- Leadership of Clinical Study Teams. Member of cross functional teams
- Support of Clinical Operations tools & departmental development
- Business travels are required for this position, around 10-20% of working time
- Contributes to development and operational design, planning of budget and timelines, feasibility assessments and initiation of clinical trial protocols and programs
- Leads internal cross functional Clinical Study Teams responsible for conducting global clinical trials to ensure project deliverables are executed on time and within budget with full oversight
- Manages external service providers including CRO(s), vendors and subcontractors
- Efficient & effective communication, exchange of information across projects & reporting lines
- Ensures clinical trials are conducted according to GCP and all applicable regulations.
- Contribution to essential study documents, coordination of reviews, manages audits & inspections
- Accountable to track trials KPI and improve trial performance
- Responsible for budget management for global clinical trials, evaluation of project budget variances / scope changes. Preparation of project change in scope orders for review.
- Contribute to the development and implementation of process improvements to ensure regulatory / legal compliance, including corrective actions and updates of procedural documents as required. Comply with training requirements.
- Manage relationships with investigators, KOLs, pharmaceutical partners and suppliers in clinical development programs to optimize delivery
- Collaboration regarding the different studies/projects with other functions to ensure Lessons Learned and Best Practice, including representation of the clinical study team.
- Assist in the project specific initiation, orientation, and training of inter-departmental project team members as needed. Support ClinOps tools and departmental development.
- Maintain knowledge of overall developments in the field of clinical research & therapeutic areas
- Relevant University Degree in biological or medical sciences
- Minimum of 3 years monitoring and successful management experience in global clinical trials in pharmaceutical industries or CROs
- Demonstrated success in coordinating external resources for clinical development and in working with pharmaceutical partners
- Experience and understanding of the drug development process and clinical trial execution
- Understanding of clinical aspects of therapeutic area along with willingness to develop in-depth expertise
- Experience in dermatology field or infectious diseases would be an advantage
- Business fluent in English and French
- Experience in leadership of cross-functional teams would be a plus
Please apply on-line. For more information, contact Ms Karine Legerot