Beschreibung
The Clinical Development Leader will oversee multiple clinical studies in Early Translational Research with the objective of leading these successfully into Phase I and Phase II. Therefore we are looking for a Clinical Scientist who can successfully demonstrate their ability to work under strict deadlines and budget restrictions to lead Clinical studies efficiently.Responsibilities:
- Set up the Clinical Development Plans for early Translational Studies through to Phase I and Phase II
- Independently translate the Clinical Development Plan strategy into high quality, highly executable clinical protocols and study documents
- Contribute to Program level documents including clinical sections of regulatory documents such as Investigators' Brochures, Health Authority documents, submission documents.
- Own responsibility of planning and managing the budget and clinical timeline deliverables
- Partner and effectively collaborate with key stakeholders internally as well as externally
- Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs.
- Train and support the CRAs & CROs on study protocol and related questions and serve as point of contact for 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.
- Responsible for the coordination of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved, and address corrective actions.
- Oversee the work of assigned support ensuring clear delegation and assignment of duties
- Contribute to the identification and evaluation of new clinical sites
Requirements:
- PhD in Life Sciences or MSc. with significant experience in Early Phase Clinical Studies
- Writing Protocols, managing budgets, creating operational timelines and overseeing clinical studies
- Experience in Drug Development
- Scientific background and interest
- Ideally have had experience in all operational levels of clinical trials such as feasibility assessment, site selection, study start up and close out, recruitment of complex patients.
- A keen interest in Translational Science.
Kontakt: Luchele Mendes
Michael Bailey International is acting as an Employment Business in relation to this vacancy.