Beschreibung
We have an opening for a Clinical Trial Leader for our Pharma client based in Basel. You will be responsible for the management and clinical execution of clinical trials within Translational Medicine. You will be responsible for the planning and implementation of all operational aspects clinical trials from study concept to reporting according to timelines, budget, operational and quality standards.Responsibilities:
- Responsible for leading and matrix managing the multidisciplinary teams and projects to ensure all trial deliverables are fulfilled according to objectives.
- You will author clinical documents including study protocols.
- Working in teams you will be responsible for the planning and feasibility assessments, selecting CROs, identifying sites and managing study set-up, including responsibility for organizing and chairing the Investigator meetings, site selection meetings.
- Train and support the CRAs and CROs on study protocol and serve as point of contact for managing/answering questions relating to trial procedures and subjects' eligibility.
- Ensure the set up and maintenance of the Trial Master File for assigned studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines.
- Chair meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards.
- Regularly update all trial information databases in order to manage accuracy of information.
- Review and approve all study payments as per financial agreements.
- Assist in data review and interactions with the Data Manager, Statistician, and third parties.
- Work closely with the Medical Expert to coordinate the medical review of clinical data and coordinate data analysis and report the data as per company
- Provide Clinical expert advice to cross-functional departments such as Drug Metabolism, DMPK, Drug Supply Management
Requirements:
- Prior experience in a similar environment, within a Global Pharma or Biotech (5 years +) is essential
- Experience in budget management, documentation including protocol writing, selecting and managing CROs.
- Education in Life Sciences at a MSc or PhD Level. BScs are also considered as long as you have a strong professional background.
- Experience in a Global environment, managing multiple, complex clinical trials.
Kontakt: Luchele Mendes:
Michael Bailey International is acting as an Employment Business in relation to this vacancy.