Director – Program Operations Leader-Hematology

Director – Program Operations Leader-Hematology

Requirements

• Bachelor’s degree and minimum of 12 years relevant sponsor-side industry experience, 8 years within clinical trial management.
• Advanced interpersonal & leadership skills
• Ability to provide operational strategic direction and guidance for clinical programs
• Advanced technical knowledge to solve highly complex issues
• An understanding of relevant industry trends
• Strong analytical skills with a data driven approach to planning, executing, and problem solving
• Advanced communication skills via verbal, written and presentation abilities
• Ability to influence and negotiate across a wide range of senior stakeholders (i.e., functional area heads)
• Budget management expertise and strong financial acumen
• Significant line management experience with demonstrated mentoring and coaching skills
• Extensive experience in global clinical trial operations
• A working knowledge of GCP and ICH

Responsibilities

• 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, as appropriate
• Ensures timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s)
• Drives decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation
• Acts as point of contact for clinical program and study level escalation
• Manages 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

Preferred Qualifications

No preferred qualifications provided.