Clinical studies are the heart of drug development. Without thorough studies taking place many drugs would not reach the market, therefore leaving millions without relevant aid for their conditions.
As a Clinical Project Manager, you will be responsible for oversight of multiple clinical projects. The position will require you to drive drug development and the business vision; in line with strategy, budgets and timelines.
- Primary clinical operations support in the development of study feasibility and set-up activities working closely with the medical lead for the program
- 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)
- Submissions to FDA and EMA bodies.
- 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
- Risk assessment and anylsis.
- 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.
- Background in one of the following therapy area's; Oncology, Immunology, Hematology, Infectious / Rare Diseases.
- 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 a necessity.
What we can offer:
- Flexible working from home structure, up to 50%
- Child care
- Company fun days
- In house canteen and provided lunch
- Gym and swimming facilities