6 Director, Clinical Operations Jobs in Boulder, CO
Sorry! This job is no longer available. Please explore similar jobs listed on the left.
Edgewise Therapeutics is Hiring a Director, Clinical Operations Near Boulder, CO
- Provide operational expertise for assigned trials and site activities.
- Meets departmental and project productivity and quality metrics and provides financial and management accountability to a wide range of audiences.
- Responsibility for direct management, including but not limited to execution and management of small pilot clinical studies.
- Performs or oversees co-monitoring visits to ensure site performance is in alignment with the company’s expectations and that monitoring is being conducted in alignment with ICH/GCP guidelines and study-specific monitoring plan.
- Collaborates with Quality Assurance in the development of Clinical Operations Standard Operating Procedures (SOP), Work Instructions (WI), training and other tools to ensure compliance with FDA Regulations.
- May manage function and people, including goal setting, team performance, communications, and talent management.
- Collaborate on clinical study planning on a program level.
- Collaborate closely with cross-functional teams to ensure strategic integration of clinical trial plans.
- Provide oversight to operations to ensure quality execution of the function.
- Optimization of departmental processes.
- Ensure GCP compliance of clinical operations function.
- Initiate and manage key vendor/partner relationships.
- Provide expertise and operational input into protocol synopsis, final protocol, Informed Consent, and other study related documents.
- Provide oversight to and input site feasibility/selection process to ensure understanding between study execution plan and program strategy.
- Provide strategic input and management of site activation activities and recruitment strategies.
- Oversight of study timelines to ensure the needs of the clinical development plan are met.
- Oversee strategic partners/CRO/vendor selection, budget and contract negotiation, and proper guidance of performance for all activities assigned to a strategic partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted.
- Review outcomes/actions related to protocol deviations review; primary purpose of review is to help identify trends across sites or the study.
- Documented review and monitoring of risks and decisions at the study level and implementation of mitigation strategies.
- Participate in Safety and Compliance meetings by reviewing adverse events, drug accountability and protocol deviations.
- Provide oversight and feedback to study team to ensure studies are "inspection ready" at all times; may be involved in regulatory inspections by preparing for and attending the inspections.
- May collaborate with other functional leads to manage project related efforts. Participates in departmental quality or process improvement initiatives.
- Bachelor's Degree (Life Sciences), nursing or business-related field required. Advance degree (e.g., MBA, MSPH) a plus.
- 12 years of clinical operations experience in clinical trial design and conduct; including 6-8 years' experience in the pharmaceutical industry or clinical research organization, 5 years clinical study management.
- Experience must include early development (Phase 1) and multicenter, global Phase 2 and 3 studies.
- Experience in more than one therapeutic area is advantageous. Cardiovascular experience preferred.
- Strong knowledge in global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, and ICH GCP.
- Strong clinical knowledge
- Clinical monitoring and auditing experience
- Experience managing clinical operations teams
- Excellence in project management and communication.
- Travel (25-30%) may be required. Addition travel to meet as a larger department, including strategy meetings, in and around the US as needed.
Job Summary
Full Time
$133k-176k (estimate)
07/22/2023
04/26/2024
edgewisetx.com
Boulder, WY
<25
Related Companies
The job skills required for Director, Clinical Operations include Clinical Operations, Clinical Research, Planning, Clinical Trial, Project Management, Accountability, etc. Having related job skills and expertise will give you an advantage when applying to be a Director, Clinical Operations. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Director, Clinical Operations. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Director, Clinical Operations positions, which can be used as a reference in future career path planning. As a Director, Clinical Operations, it can be promoted into senior positions as a Critical Care Director that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Director, Clinical Operations. You can explore the career advancement for a Director, Clinical Operations below and select your interested title to get hiring information.
Similar Jobs
Popular Articles
