Location: Switzerland - Meyrin/Geneva
Company: OM Pharma
In view of our continued global growth, we are looking for our new Clinical Trial Manager in Meyrin/Geneva.
Reporting to the Clinical Operations Lead, your main missions are related to the Clinical Trial Management of OM Pharma sponsored clinical trials:
- 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
Your key tasks will include the following:
- 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
To carry out these tasks the ideal candidate will have the following skills:
- 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
- Business fluent in English and French
- Experience in leadership of cross-functional teams
- Experience in dermatology field or infectious diseases.
You are a dynamic, hands-on person, able to lead a cross-functional team. You act in an entrepreneurial and innovative manner. You collaborate across the organization in an agile way and apply pragmatic and simple solutions. You are a team player and act as a role model for the OM Pharma values.
If this sounds like you please do apply to this new position with us at OM Pharma in Meyrin/Geneva.
OM Pharma is a global Geneva-based Biotech company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.
It operates worldwide through a strong network of international partners and continues to invest into R&D to develop microbial derived immunotherapeutic products addressing acute and chronic immunological disorders resulting from infections and inflammation. OM Pharma is operating to highest Good Manufacturing Practice (GMP) standards which rely on a high level of Biotech competencies and experienced teams.
The company strives to help patients around the world to live better lives by allowing access to a better management of infectious diseases and immunological imbalances.
For more information, please visit: ompharma.com.