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

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.

AD, Clinical Operations

Key skills