Summary
Citryll is a start-up biotech in Oss that specializes in immunology. We are pioneering a transformative approach to treating immune-mediated inflammatory diseases by targeting Neutrophil Extracellular Traps (NETs), a fundamental component of the inflammatory processes that has yet to be addressed therapeutically. With 20 employees, we are in an exciting phase as our lead product is entering the Phase IIa in two indications. We are looking for an experienced Clinical Trial Manager to manage these clinical trials.
Responsibilities
- Serving as primary point of contact for study vendors to ensure effective communication and collaboration.
- Serving as the primary contact person for sites e.g. through co-monitoring visits
- Coordinating and managing study activities, including outsourced activities such as site selection, site monitoring, IMP management, data collection, and filing of study documentation.
- Ensuring that the study is conducted in accordance with Good Clinical Practice (GCP) guidelines, ethical standards, and regulatory requirements.
- Monitoring study progress and identifying and resolving any issues or challenges that arise during the course of the study.
- Collaborating with a cross-functional team to ensure the successful execution of the study.
- Overseeing the preparation and submission of study documents and reports to regulatory agencies for review and approval.
- Providing project related training and mentoring of involved (junior) staff where necessary.
- Senior CPM only: coaching and training of CPM as appropriate.
- Senior CPM only: Program Level responsibilities (as required) in agreement with HCO.
- Senior CPM only: lead cross-functional team (as required) in agreement with HCO
Qualifications & Experience
- MSc. graduate, preferably in a healthcare related discipline
- More than 5 (or 10 years for senior CPM role) years relevant working experience in (bio-) pharmaceutical clinical research, including project management experience
- Good computing skills (MS-Office standard software package, project management, trial and document management systems)
- Leadership skills
- Excellent organizational and communication skills.
- Independent and self- sufficient to evolve and expand future activities of Citryll
- Professional, proactive, efficient and flexible
- A thorough knowledge of ICH guidelines, Good Clinical Practice, and international regulatory requirements
- The capacity to work in a small, non-hierarchical organization with a fast pace is required as is the ability to work well within a broader team environment involving professionals with all levels of expertise and experience
- Team player and ability to work with remote teams
- English fluency written and spoken
- Strong verbal and written communication skills with well-structured communication and presentation ability
