Chase Weston are actively searching for a talented individual to join a European focused Contract Research Organisation to take on the role of Director of Clinical Research and Operations.
The candidate will oversee an internal clinical team and continuously manage external vendors internationally to support the successful completion of clinical trials across a range of therapeutic areas.
Key roles and responsibilities:
- Lead cross-functional activities from start-up to close out in accordance with program goals and timelines.
- Line management of the Clinical Operations team, including responsibility on project assignment, budgeting and timelines.
- Accountability for compliance (SOP/GCP).
- Identify, coordinate and oversee any third-party vendors (CROs/central laboratories, consultants, etc.).
- Knowledge of ICH-GCP and other relevant documents.
- Engage in site visits to oversee progress and CRA monitoring.
- Develop and implement process improving strategies.
- Liaising with Board of Directors and the executive team regarding progress and financial feasibilities.
- Assisting the business development activities.
- Degree in Life Sciences.
- Strong managerial skills.
- Previous vendor governance experience.
- Phase I through phase IV experience.
- Minimum of 5 years of direct CRO experience, plus additional pharma/biotech exposure.
- High level of negotiation and communication skills.
- Demonstrate awareness with auditing processes.
- Familiarity regarding FDA procedures.
- Experience completing projects and aligning resources.
- Understanding of quality, regulatory and medical affairs.
Job Reference: CRO021020DH