A biotechnology company in Frankfurt are looking for a bright and talented Project Manager to lead clinical developments. The individual will be able to step up and help the organisation make life changing improvements to medicine.
- Participate in the process of clinical development strategy creation and implementation
- Responsible for all aspects of study management, oversight and site monitoring
- Manage CRAs and study teams
- Provide resource and budget planning information for clinical operations
- Manage the process of negotiation contracts
- Contribution to the submission package to the Regulatory Authorities
- Complete process of Safety reporting, process production of reports, narratives and follow up
- Ensure the completion and accuracy of project-specific tracking requirements including patient enrollment and regulatory documents
- Ensure support in regulatory affairs and compliance for medical projects,
- Establish relationships with key opinion leaders (KOLs),
- Engage in scientific discussions with health care professionals (HCPs) on current topics related to hepatitis Delta and various treatments to help physicians make informed decisions and improve clinical practice and care,
- Monitor and communicate on newly published data in your area of expertise,
- Respond to requests for medical information scientifically,
- Raising awareness of the relevant indication so that investigators, KOLs, HCPs and site staff are provided with relevant, compliant and consistent medical and scientific support
Skills and Requirements
- A degree in natural sciences
- CRA/site monitoring experience and GCP knowledge
- Motivation to broaden the scope of clinical tasks to the medical field
- Readiness to develop in the medical affairs area
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Nico Kohlwes on +49 69 94189257 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.