Are you an enthusiastic manager with experience in clinical trial feasibilities and site identification? Would you like to work at in a global team in which you can bring your expertise to further build the department? Are you interested in working in a growing boutique CRO with several therapeutic areas and a strong focus on oncology?
The individual in this role produces recommendations for country and site selection strategies, as well as enrollment projections and recruitment challenges. In this capacity, the Feasibility Manager assures the integrity of the data sources used as well as the proper interpretation and resulting strategy provided in feasibility proposals and reports, (feasibility proposals are documents that detail the strategy, actions, and the cost of conducting feasibility, while feasibility reports are documents that describe the outcomes of feasibility projects). The Feasibility Manager is responsible for setting priorities for workload and deliverables and assuring that the individual elicits input from and coordinates activities with all of the stake holders in the feasibility process including: Proposals, Investigator Strategy and Site Coordination, Regulatory, Medical Affairs, Clinical Operations and Project Management and any other identified stakeholder.
- Bachelor / Master degree in a related field of study and a minimum of 5 years applicable. industry experience or equivalent combination of education and experience.
- 1-2 years experience as a CSM, PM, or Sr. CRA is required.
- A minimum of 4 years’ experience in the conduct of clinical trials is required.
- Demonstrated knowledge of government/international databases, open source databases or more proprietary databases (e.g., PubMed/Medline, ClinicalTrials.gov, Cite line).
- Demonstrated ability to form strong working relationships with other groups within the organization essential to high-level performance in this position.
- Demonstrated knowledge of quality assurance related to the Feasibility process and willingness to promote the quality process within the group.
- Ability to motivate, lead, and grow a team.
- Experience with pharmaceutical product development.
- Working knowledge of GCPs, ICH guidelines, EMA and other applicable country regulations.
- Effective verbal and writing skills; English.
You will be part of CATO SMS’ Clinical Trial Operations team that provides clinical services; for example project management, site and investigator selection, site management, monitoring and regulatory affairs.
CATO SMS has a unique business model of integrating oncology drug development affairs and clinical operations, we cover the whole value chain from trial design to the setup, management and completion of phase I to IV oncology trials. We specialize in early phase, pediatric and immuno-oncology trials. We believe that oncology trials require oncology experts. Our clients can rely on our expertise and our proactive, responsive and pragmatic approach. Our mission is to excel in oncology trials for the benefit of our clients and cancer patients worldwide. CATO SMS nurtures a high performance culture, provides continuous training, offer unique opportunities to learn, and stimulates personal and organizational development. Our high performance culture impacts our retention rate positively, as represented by our industry leading rate of ~95%.
Do you want to know more about this vacancy, please contact our HR Manager, Ariane des Tombe via +31 (0)20 4350580.