The Director of Clinical Operations will be responsible for executing the clinical development strategy to ensure that all clinical development activities within the company are conducted efficiently to agreed corporate timelines and in compliance with local and global requirements.
typical roles and responsibilities for Director Clinical Operations
- Implement clinical development plans in order to meet corporate goals and objectives.
- Work with other departments and functions to implement clinical trial protocols.
- Participate and assist in design and preparation of protocols and case report forms.
- Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
- Evaluate potential clinical CROs and sites according to established criteria of acceptability.
- Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
- Supervise and oversee contract research organizations, clinical vendors, and consultants
- Supervise and manage activities of clinical operations personnel.
- Prepare clinical documents for regulatory submissions.
- Attend scientific and external training meetings as needed.
- Willingness to travel (up to 25%)
Requirements for Director Clinical Operations – Life Sciences
- BA, BS, RN, BSN or equivalent
- Thorough knowledge and adherence to GCPs
- Strong attention to detail
- Ability to multi-task
- Minimum of 10 years’ experience in study management
- Prior experience in conducting international studies preferred
- Unquestionable integrity and highest ethical standards
- Excellent written and verbal communication skills
- Self-motivated, assertive, driven, and hands-on leader
- Ability to operate collaboratively with colleagues across functional areas in an entrepreneurial and science-driven environment
- Ability to forge solid personal and professional relationships with key opinion leaders and investigators
- Ability to read, analyze, and interpret common scientific and technical journals and related documents. Ability to effectively respond verbally and/or in writing to technical inquiries from clinical investigators, customers, sales force, or internal person on topics related to products. Ability to effectively prepare and present technical information/data for internal venues or at scientific meetings. Ability to write and submit final manuscripts for publication in peer-reviewed journals, and technical documents for regulatory submission.
- Ability to apply moderate to advanced mathematical concepts to clinical and research data analysis such as p values, regression analysis, analysis of variance, etc
- Ability to define the key issues or problems, to collect information and data for problem solving, and to recommend an effective approach to problem solving and project completion. Ability to understand and use abstract and concrete variables and concepts.