Head of Clinical Operations DACH
Proclinical has partnered with a large biotech in Germany in search for a talented Head to lead the Clinical Operations in Germany.
- Manages/oversees the on-time and within budget execution of all clinical trials within DACH. Provide local regulatory and legal requirement expertise.
- Conduct and/or implement impact analysis of all significant changes to conform with updated regulatory / industry regulations affecting conduct of clinical studies.
- Ensures audit and inspection-readiness at all times. Country contact for regulatory agency questions related to monitoring processes and procedures. Drive CAPA preparation and implementation.
- Accountable for managing country/district resources including need identification, timely hiring and allocation, and managing changes to hiring plan.
- Accountable for functional budget planning and administration.
- Provide leadership to the team members within the region and be accountable for growth and development of a world class workforce
- Drives a learning environment and ensures continuous improvement in the region's performance by using innovative approaches, active analysis of Key Performance Indicators, metrics and milestones.
- May lead global Task Forces and Initiatives. Interacts with peers within the industry to stay abreast of regulatory landscape.
Skills and Requirements
- Bachelors or equivalent degree. Health sciences related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred. Graduate degree preferred.
- Site Monitoring Experience: Minimum 3 years having monitored and/or managed a study within a Country from start to close.
- Experience in functional budget planning, resource planning & and assignment, quality management in a Country lead capacity preferred.
- At least 4-5 years of experience in line management of staff including acquisition of talent, performance management.
- Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.