Description
We are looking for a
Clinical Study Consultant Generics (m/f)
Reference: -en
Start: asap
Duration: 2 MM+
Place: in Bavaria
Branch: Pharmazeutische Industrie
Your tasks:
- Ensure decision making for clinical studies, and organize respective communications internally, and/or with other companies (in a consortium), and/or with Health Authorities (Referral studies)
- Ensure studies are implemented and reported as required if studies are not conducted, ensure this is communicated to the relevant parties, internally to exit/prune the product (Referral studies)
- Ensure that adequate standards & procedures (e.g., GOPs, oversight tools, audits, training, etc.) are in place (Post-marketing)
- Ensure studies are conducted in full compliance with external and internal standards globally (Post-marketing)
- Ensure these standards are known and understood, and implemented, globally, and respective central oversight of any non-compliances exists, and is escalated and addressed as appropriate (Post-marketing)
- Implement a respective IT tool, as needed (Post-marketing)
Your qualifications
- Profound experience in Pharmaceutical Industry, in Project Management and/or Study Management, ideally has designed / conducted studies
- Academic degree in life sciences (Physician, Pharmacist, or equivalent)
- Great communicator, outgoing personality, able to talk to Senior Mgmt. representatives
- Ability and desire to drive projects autonomously, while involving the right internal stakeholders & decision making bodies
- Attention to detail, and high quality and precision of documents / documentation
- Fluent in English (ideally native speaker)
Skills:
- Clinical development manager