Title: Clinical Project Manager / Regulatory filing
Location: Basel, Switzerland
In this role of Clinical Project Manager you will be act as a bridge between Clinical Projects and Regulatory submissions. The position will require you to drive the business strategy; in line with company vision, budgets and timelines.
Your role:
- Primary clinical operations support in the development of study feasibility and set-up activities working closely with the medical lead for the program
- Ensure regulatory standards are being met in a Global Phase 3 study
- FDA and EMA submissions
- Management of internal CRA teams as well as external CRO's
- Development / Co-development, review and approval of study documentation (Study protocols and amendments, IB, Patient consent forms, case report forms, study manuals and study tools)
- Support logistics of the trial, to include budget tracking, IMP oversight
- Co-ordinating strategy alongside PreClinical and Commercial teams
- Support clinical operations process initiatives and SOP development activities
Requirements:
- Ideally PhD educated in a Life Science / Science discipline. University level education will also be considered.
- Sound knowledge of EMA, FDA and GCP / ICH regulations, laws and guidelines.
- Ideally a background in one of the following Therapy Areas; Oncology, Gastroenterology, Rare Diseases or Haematology.
- Background in Clinical Project Management. Other Clinical management positions will be considered; clinical study manger, clinical operations manager, clinical trial manager.
- Business proficient English, both written and spoken. Any other languages are desirable.
- Career progression from CRA (clinical research associate) into management is desirable but not necessity.
What we can offer:
- Flexible working from home structure, up to 50%
- In house canteen and provided lunch
- Gym and leisure facilities
