Director, Program Operations Leader

This role is a hybrid role on-site 3 days per week and 2 days from home. A fully remote role is not possible.The Director Program Operations Leader (POL) is responsible for leadership and overall strategic management of one or more complex 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 research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The Dir 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 Dir 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 communicate 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).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 development of best practices within CTM.Oversee clinical study budgets within a program: ensure review, presentation and approval of initial study budget and manage the budget through the lifecycle of the program by communicating changes to TA Operations Leader, 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 integrate 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.Provide proactive creation and implementation of risk mitigation strategies.Provide innovative and flexible operational solutions and options to the cross functional and development teams; assist in preparing scenarios for creative solutions to operational challenges.Drive the strategy and oversight for vendor selection and management within a clinical program(s).Manage the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts.To be considered, you must possess a Bachelor’s degree, and a minimum of 12 years relevant industry experience, with 8 years within clinical trial management.Salary Range (annually):

$198,000.00 - $330,000.00

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