Associate Director, Program Operations Leader
2 months ago
The Program Operations Leader (POL) is responsible for leadership, implementation and delivery of the operational strategy of one or more programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff, including responsibility for staff recruitment, development, coaching, mentoring and performance management.
In a typical day you will:
- Be responsible for the overall success of the clinical study team(s) within a program(s)
- Maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested
- Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development
- Oversee clinical study timelines within a clinical program(s)
- Provide input and operational insight into Clinical Study Concepts (CSC)
- Be responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol
- Review plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTM
- Oversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader or Director POL, as appropriate
- Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s).
- Drive decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation
- Act as point of contact for clinical program and study level escalation
- Review key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress
- Ensures inspection readiness throughout the clinical program lifecycle and is the cross functional leader for Regulatory Authority Inspections
- Responsible for CTM resource forecasting and resource allocation for clinical studies across one or more clinical programs
- Responsible for direct supervision of CTM staff. Line management responsibilities include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.
- May require up to 25% travel
This job may be for you if you have:
- Bachelor's degree and 10+ years of progressive, related pharmaceutical industry experience with a concentration in clinical trial management.
- Early Oncology experience is a strong plus
- Strong interpersonal & leadership skills
- Ability to provide operational strategic direction and guidance for clinical programs
- Applies technical knowledge to solve complex issues
- An understanding of relevant industry trends
- Analytical skills with a data driven approach to planning, executing, and problem solving
- Effective communication skills via verbal, written and presentation abilities
- Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
- Ability to influence and negotiate across key stakeholders
- Budget management expertise
- Ability to build, lead and develop productive teams and collaborations
- Strong project management, cross-functional team engagement and organizational skills
- Demonstrated vendor management experience
- Line management experience with demonstrated mentoring and coaching skills
- Extensive experience in global clinical trial operations
- A working knowledge of GCP and ICH
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