Columbia, MD, USA
Reports to: Medical Director
Location of position: Columbia, Maryland
Position type: Full-time
POSITION SUMMARYThis position will set the direction for US clinical operations, manage a growing team of CRAs, and support corporate clinical goals. This individual will serve as a medical/scientific consultant to clinical, marketing, and research project teams. In this role, the individual will drive overall strategy and execution of Ambu's clinical evidence generation and utilization program.
Essential Functions and Responsibilities Head of Clinical Operations
- Manage US Clinical Operations team and budgets in alignment with corporate clinical strategy
- Work in collaboration with corporate clinical staff to meet set objectives
- Directly responsible for day-to-day management of clinical operational staff to execute on clinical investigations and other relevant clinical activities including own active participation
- Set clear objectives and clinical strategy to support the team in driving clinical activities to support Ambu products from launch through to end of product life.
- Translation of business objectives into requirements for clinical investigations and meeting regulatory requirements for clinical documentation and post-market surveillance.
- Responsible for coordination of the US (regional) clinical research study portfolio
- Create and maintain a culture with a strong focus on constantly improving daily execution of clinical activities/clinical investigations
- Ensure adequate clinical resources to drive relevant clinical launch and maintenance activities
- Responsible for adherence to corporate clinical QMS procedures and ownership of any local clinical QMS processes
- Define and acquire the necessary key competencies in the area to ensure long term success
- Develop the capabilities of the staff to create an efficient clinical team, including but not limited to, competence development, coaching, and performance management.
- Represent organization as a primary contact for specific projects and initiatives through communication with internal and external customers and vendors at various levels
- Develop and maintain strong working relationships with physicians and scientists
- Travel as needed (up to 50%)
- Advanced degree in clinical or life sciences (biomedical, engineering, physiology, epidemiology, RN, etc.)
- Successful track record of managing a team of CRAs
- Strong preference for additional clinical research certifications such as those from ACRP or CRS
- Clinical background: RN/PA/RT (Preferred)
- 5+ years of direct clinical research experience in the medical device, pharmaceutical, biotechnology or CRO industry
- Previous experience with successful completion of clinical studies
- Excellent working knowledge of clinical research processes, good clinical practices, federal regulations and applicable local laws pertaining to clinical research investigations
- Understands and complies with medical device quality procedures and instructions
- Strong knowledge base of medical terminology
- Excellent written and verbal communication