Clinical Project Manager II managing biomarker studies for clinical trials at Syneos Health. Overseeing operations, ensuring project success, and providing leadership to cross - functional teams in a fully remote role.
About the role
- Associate Director at Verastem Oncology overseeing phase 3 global clinical trial. Leading operational execution and compliance with regulatory guidelines for oncology-focused studies.
Responsibilities
- Oversee a high profile, phase 3 global clinical trial
- Operational leadership and development of clinical operations personnel
- Successful execution of clinical trials according to regulatory guidelines
- Oversight of timelines, budgets, resources, clinical trial sites, vendors and key project deliverables
- Oversight and continuous improvement of department infrastructure through the development of SOPs, guidelines and technology
- Facilitate effective internal and external relationships
- Achievement of project goals and objectives
- Lead cross-functional study team, external service providers and clinical sites to ensure trial deliverables are met
- Responsible for authoring or reviewing clinical study documents
- Provide input to Clinical Study Reports and Investigator Brochures
- Work cross-functionally to coordinate timely exchange of information
- Provide oversight and guidance to clinical operations teams
Requirements
- 10+ years’ experience direct Clinical Operations experience
- BS/BA in a science or health-related field (Master’s preferred)
- Experience in oncology
- Robust computer skills (Microsoft Office Suite, Veeva Vault, RTSM/EDC Platforms, Data Review Platforms)
- In depth and working knowledge of ICH/GCPs, FDA regulations and the Drug Development process is essential.
- Excellent written and oral communication skills.
- Demonstrated leadership, problem solving, conflict resolution, and team building skills.
- Proven ability to manage a group effectively.
- Ability to advise, direct and manage team to resolve problems and to achieve goals on schedule.
- Ability and willingness to travel.
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