Description
We are looking for a
Clinical Trial Head (m/f)
Reference: -en
Start: asap
Duration: 5 MM+
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Lead and direct all aspects of global oncology clinical trials
- Lead the development of global clinical protocols as well as of medical and scientific trial related documents
- Responsible for operational and functional management of clinical managers
- Lead and manage the global cross-functional Clinical Trial Team
- Develop clinical outsourcing specifications to facilitate bid process and selection of contract research
- Develop Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan in collaboration with the trial data manager, trial statistician, statistical programmer and medical lead
- Lead the Data Review Team (DRT) and participate in developing and executing the data review plan
- Forecast trial resource needs
- Contribute to program level activities
- Responsible for education, implementation and compliance to standards (SOPs) and best practices
Your qualifications
- Advanced (e.g. Master's) degree or equivalent education/degree in life science/healthcare is strongly recommended
- Profound technical, operational and managerial experience in planning, executing, reporting global clinical studies in a pharmaceutical company or contract research organization
- Excellent communication, influencing and negotiating skills
- Strong project management skills and demonstrated ability to meet timelines
- Proven ability to work independently, to lead a multidisciplinary trial team in a complex matrix environment (including remote or virtual team environment)
- Experience in developing effective working relationships with internal and external stakeholders
- Thorough knowledge of Good Clinical Practice, clinical trial design and global drug development process
- Strong knowledge of oncology, haematology, endocrinology or any appropriate therapeutic area is of advantage
- Fluency in English (oral and written)
Skills:
- Clinical project manager
Keywords: Clinical Project Manager