Head of Clinical Operations DACH
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Hobson Prior are in search for a Head of Clinical Operations DACH who will join a biopharmaceutical organisation who are determined to discover and deliver pioneering medicines to solve serious health issues.
Please note that to be considered for this role you must have the right to work in this location.
- Manages/oversees site/country or district related activities as they relate to the organisation's clinical studies.
- Accountable for the on-time and within budget execution of all clinical trials within DACH. Provide local regulatory and legal requirement expertise.
- Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, company Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
- Monitor regulatory reforms and industry trends within country / region. 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. Responsible for staff recruitment and retention plans.
- Accountable for functional budget planning and administration.
- Provide leadership to the team members within DACH countries and be accountable for growth and development of a world class workforce that role models the company behaviors.
- Drives a learning environment and ensures continuous improvement in DACH performance by using innovative approaches, active analysis of Key Performance Indicators, metrics and milestones. Driving simplicity in process and approach and enhancing agility.
- Accountable for ensuring SMM leadership, collaboration and teamwork across all key stakeholders within the DACH Countries.
- Any other assigned duties.
- Demonstrating business ethics and integrity.
- Robust analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
- Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity.
- Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with experience leading (within country or region) projects with competing deadlines.
- Requires a bachelors or equivalent degree - Health sciences related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred. Graduate degree preferred.
- Minimum 3 years having monitored and/or managed a study within a Country from start to close (experience with Germany, Austria and Switzerland highly desired).
- Fluent in German and English.
- 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, growth and development, managing employee relations, coaching and mentoring of staff and teams preferred.
- Experience across multiple Therapeutic Areas and Study Phases.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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