Management Role and Responsibilities:
This role will have multiple clinical operations direct reports at varying levels, e.g., Clinical Operations Program Managers and Clinical Operations Study Leads. Responsibilities include professional development, performance appraisals, and employee counseling. This role reports to the Head of Clinical Operations
- Responsible for the operational strategy and overall execution of assigned clinical program(s) which includes focus on budget, timelines, quality, resource management and providing operational strategies in support of achieving clinical program objectives.
- Develop and actively manage clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets. Ensures compliance with SOP’s, GCP and ICH guidelines.
- Develop and coordinate operational plans for a clinical study or multiple clinical studies within a development program (i.e. study timeline projection, drug and budget forecast, safety plan, monitoring plan, study management plan, issue escalation and resolution plan).
- Lead the Clinical Operation team(s) including in-house team members and Contract Research Organizations (CROs), vendors and other suppliers to ensure work quality, timeliness and adherence to budget.
- Responsible for the selection, oversight and performance of CROs, Contract Laboratories and other vendors for assigned programs.
- Represent the company at clinical sites and external project meetings as required.
- Responsible for the clinical section and overall development update for annual report and IB.
- Direct and manage Clinical Operations financial planning/forecasting and budget management and monitor the budget against actuals.
- Line Manager for Clinical Operations staff
- Recognized as a clinical operations expert by other functions and ability to represent and lead cross functional initiatives.
Qualifications and Education:
- B.A./B.S. in a science, RN, Pharma D / Master’s degree preferred
- 12+ years of experience in clinical research in the pharmaceutical industry, including 9+ years clinical study/program management; program management experience required
- Strong working knowledge and applicable understand of CFR and ICH GCP guidelines
- Experience in setup, execution and operational management of domestic and international Phase 1, 2, and 3 clinical trials across an array of therapeutic areas. Experience as a program manager ensuring program timelines are achieved
- Good understanding of clinical study implementation process
- Must be able to review clinical study tables and listings to ensure clinical data integrity
- Proficiency in managing and developing clinical operations personnel and CROs
- Some travel may be required