Lead Clinical Operations Strategist
The Director Program Operations Leader (POL) oversees the strategic management of complex programs in Clinical Trial Management (CTM). This role is responsible for clinical operations activities and decisions, ensuring quality, timelines, and budgets are aligned with applicable regulations, ICH/GCP guidelines, and company Standard Operating Procedures (SOPs).
This individual interacts with senior management, external vendors, collaboration partners, and clinical study personnel to drive clinical research project and department initiatives.
Key Responsibilities:
* Oversee the success of clinical study teams within a program(s)
* Maintain an overview of clinical program(s) status and issues, proactively communicating progress, risks, or changes that may impact quality, timelines, or budget;
* Provide clinical program level updates to stakeholders as requested
* Offer 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)
* Review plans and provide clinical operations expertise during protocol design, feasibility, study start-up, and conduct phases of studies.
* Ensure consistency within the program and develop best practices within CTM
* Manage clinical study budgets: review, present, and approve initial study budgets, and communicate changes to TA Operations Leader as necessary
* Ensure timely delivery of quality operational deliverables and accountability for ensuring consistency of process and approaches across clinical study teams within the clinical program(s).
* Drive decision-making and integrate all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation
* Supervise CTM staff: line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.
Requirements:
* A Bachelor's degree and minimum 12 years of relevant industry experience, 8 years within clinical operations