Job Listing
Director, Clinical Operations
Job Type
Permanent
Employment
Full Time
The Director will report to the VP, Clinical Operations and will work closely with a cross-functional team in a fast-paced high growth environment team to ensure that clinical trials are conducted on time and budget, and in accordance with applicable GCP/ICH guidelines and other regulatory requirements.
Job Responsibilities
- Accountable for the overall management of assigned clinical programs (across multiple studies), including providing strategic direction to study teams to ensure timely clinical trial execution.
- Responsible for maintaining inspection-readiness across clinical programs.
- Assist in development of hiring/resourcing plans and program budgets.
- Manage multiple direct reports.
- Mentor and oversee junior team members.
- Provide oversight of clinical research organizations (CROs) and other key vendors to ensure timely and quality deliverables.
- Provide a point of escalation for clinical trial execution issues.
- Lead preparation of vendor requirements and project scope and selection of study vendors.
- Responsible for clinical vendor selection.
- Contribute to the establishment of KPIs to measure vendor performance.
- Implement appropriate systems, standards, and processes to ensure quality at the level of investigative sites, vendors, and data.
- Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results.
- Oversee set-up and implementation of effective investigator and site monitor training; facilitate operational and therapeutic area training for internal and external study team members.
- Review study invoices and participate in accrual reviews to track the financial status of the study against budget.
- Responsible for establishing clinical operations SOPs, Work Instructions, guidelines, standards, and best practices.
- Drive and implement infrastructure initiatives, process improvements, change management, and ad-hoc business projects.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.
- Bachelor’s degree required.
- 12+ years of experience working with CROs to manage large global clinical trials.
- 3+ years of experience managing direct reports, evidencing strong leadership, team-building, and hands-on management.
