Responsibilities
Design, implementation and coordination of clinical studies with the support of the Clinical Operations, Pharmacovigilance, Biometrics and Medical Writing departments:
- Planning the clinical development program
- Writing protocols, amendments and study reports
- Writing regulatory files
- Managing relationships with investigators and opinion leaders
- Implementation and monitoring of actions to meet recruitment deadlines and good clinical practices
Profile
- Holder of additional training in methodology (CESAM, DIU, ..
.
)
- Successful experience as a ClinicalProjectManager in a pharmaceutical laboratory or CRO
- 6 to 8 years of experience clinical development (phase II and III)
- Experience in oncology or in auto:
immune inflammatory pathologies would be a plus.
- International development experience essential
- Control of the regulatory environment for clinical trials
- Experience in writing study reports and FDA (IND, NDA) and EMA regulatory dossiers
- Fluent English imperative
Terms and conditions
- Permanent contract (CDI) to be filled as soon as possible
- Paris office
- Salary to be defined according to profile and experience
Please reach out to Lewis Coulson :
Consultant/Clinical Research for more details at ACHIEVAGroupLimited paris Science CDI EUR60000 to EUR90000 per annum
