Clinical Research Manager
Location: GermanySmall pharmaceutical company that develops new cannabioniod based medication.
Research oriented and informal company.
Echo Pharmaceuticals is developing cannabinoid based medication. It is a small company, recently relocated to Leiden, hence with a startup culture in a new team. We have developed proprietary formulation technology and performed clinical trials phase I and II. Additional indications need to be researched and prepared as well as phase III preparations with partners in different parts of the world.
Working at Echo means the opportunity to shape the program and have a big impact on the development of the company and the team. You will be working in an entrepreneurial environment. Echo is on an exciting journey to become financially self supporting and building a network of partners and customers to develop the cannabinoid market.
We’re looking for a clinical research manager to join our team! This is a permanent role to be located in Leiden. You need to speak English. Dutch is a nice to have.
- Developing Clinical Roadmap and Investors pitch.
- Managing Clinical trials with the CRO’s and sites.
- Provide relevant input to and review of clinical trial protocol.
- Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements.
- Monitoring data with a focus on data integrity and patient safety, in accordance with specific country regulations.
- Preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites.
- Ensuring adherence to study timelines and budgets.
- Managing external partners supporting clinical trials, e.g. consultants
- Undergraduate degree or its international equivalent in clinical, science, or health-related field
- Prior experience in monitoring of pharma trials
- Working knowledge of FDA Guidance Documents / EU Directives / local regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- Ability to work effectively in an entrepreneurial environment with changing priorities
- Strong verbal and written communication skills
- Excellent organizational and time-management skills, able to meet deadlines
- Self-starter with common sense and able to act on own initiative
- Accountable, dependable and strong commitment
