Category

Description

Job Duties

• Responsible for the overall success of the clinical study team(s) within a program(s)
• Maintains 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
• Provides operational insight into feasibility, timeline and cost estimates during clinical program/study development
• Oversees clinical study timelines within a clinical program(s)
• Provides input and operational insight into Clinical Study Concepts (CSC)
• Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensures consistency within the program and development of best practices within CTM
• Oversees 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
• Reviews key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress
• Provides proactive creation and implementation of risk mitigation strategies
• Provides innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges
• Drives the strategy and oversight for vendor selection and management within a clinical program(s)
• 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
• Identifies and recommends changes to practices and policies, including initiating and participating in strategic projects, initiatives, and continuous improvement projects within Global Development
• Attends and represents CTM for a program(s) at review committee meetings as appropriate
• Participates in CRO governance meetings as needed for clinical program(s)
• Participates in Joint Meetings with Collaborative Partners at the study level and program level
• 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.

Key Team Membership

• CTM Leadership Team
• Vendor Governance Committee(s)
• Clinical Operations Review Meeting(s)
• Development Team(s)
• Clinical Compliance Meeting(s)
• Strategy Review Meeting(s)

Cross Functional Interfaces

• Interface with key clinical and regulatory functional area leads
• Project Management
• Medical Director(s)
• Procurement
• Clinical Finance

Requirements

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