Description
We are looking for a
Clinical Project Manager (Phase 3b/4 and NIS) (m/f)
Reference: -en
Start: 04/16
Duration: 12 MM+
Place: in Bavaria
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Project execution, coordination and oversight of all assigned tasks within globally conducted phase 3b/4 and non-interventional (NIS) clinical trials in the CV area
- Matrix-related working with global, cross-functional and cross-cultural project teams, in-house and with external vendors in Europe, South America and Asia
- Deputizing for the Late-Phase Operations Lead with respect to all assigned functions and activities
- Ensure oversight of all relevant internal and external CRO/vendor study activities according to internal SOPs and external laws and regulations
- Key regions: Europe, and limited countries in South America and Asia
- Liaison with Global Medical Affairs team in US and in EU
Your qualifications
- Master degree in health profession and/or science field
- Profound experience in clinical research and operations, as well as project management experience (at CRO and/or sponsor)
- Experience in late-phase clinical operations preferred
- Sound knowledge of project management tools and practices in an international, cross-cultural, clinical environment
- Working knowledge and understanding of non-interventional (NIS) clinical study settings and of ICH-GCP, regulations governing clinical trials, standard regulatory and clinical practices and current regulatory issues related to clinical research
- Demonstrated aptitude and knowledge in cardiovascular (CV) therapeutic area and ability to learn and integrate new/different therapeutic areas
Skills:
- Clinical project manager