Department: Clinical Affairs
Clinical Operations is accountable for the leadership, strategic planning, oversight, execution of clinical operations and the management of staff responsible for our products. The individual must have the ability to work independently and also as an effective and engaged team member in a dynamic, fast-paced environment. As a member of a growing team the Director of Clinical Operations must be flexible and willing to carry out tasks outside of their routine responsibilities.
DUTIES & RESPONSIBILITIES
The role of the Director of Clinical Operations includes but is not limited to the following responsibilities and skill sets:
- Build out and oversee the Clinical Operations function, processes and all activities related to execution of clinical studies and programs in accordance with regulatory guidelines
- Develop efficient, scalable system approaches to planning and implementing clinical trial operations that effectively integrate clinical operations and other functional areas
- Recruit, motivate and provide oversight for all in-house clinical operations and external department staff and resources associated within clinical operations, CRO’s and vendors
- Direct the successful execution of all clinical trials, programs, timelines and clinical milestones to ensure the successful execution of clinical programs and clinical operations to time, on budget and with quality
- Accountable for oversight of clinical operations activities within the program(s) and for ensuring provision of clinical operations expertise/input into the program (e.g. feasibility, country selection, operational input into design, Risk based Quality Management and external partner management)
- Identify and resolve clinical operations issues related to data management, monitoring, timelines, safety assessment, regulatory compliance, and timely review of trial master files, etc.
- Manage budgets, contracts, agreements, vendor payments and processes to conduct clinical trial programs in an effective manner.
- Oversee data collection activities for all clinical programs: CRF, SAE assessment, queries, and follow-up, annual reports, investigator brochures, etc.
- Perform other duties as assigned.
- BS in a scientific discipline with 10+ years of Clinical Operations line management experience (an equivalent combination of education and experience may be considered ). MS or PhD is preferred.
- Extensive background in Medical device clinical research and development.
- Proven history of device development, demonstrated through comprehensive clinical trial design and execution and prior regulatory accomplishments.
- Demonstrated experience leading multi-site or large-scale clinical trials research.
- Proven experience hiring, leading clinical operations teams and overseeing their career growth skills
- Experience managing a rapidly changing organization and integrating new personnel is essential, as well as, ability to evaluate and resolve complex problems
- Demonstrated experience in CRO and vendor management to support global clinical trials, including excellent senior leadership, project management, budgeting, and negotiation skills, required
- Management experience with developing strategies and leading the administrative and financial operations of a large organization academic and/or industry-based clinical research organization.
- Strong knowledge of FDA/EMEA regulations and GCP/ICH guidelines regarding clinical trial management.
- Excellent verbal and written communication skills and ability to relay vision/strong sense of department organization, processes
- Travel will be required