AD, Clinical Operations

Verastem•Boston, MA

1d•Hybrid

About The Position

Working closely with the Head of Clinical Operations, the Associate Director will oversee a high profile, phase 3 global clinical trial. Responsibilities include operational leadership, 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 the use of technology; facilitation of effective internal and external relationships, and achievement of project goals and objectives.

Requirements

Seasoned Clinical Operations with prior experience managing Global Phase 3 trial is required.
10+ years’ experience years 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.

Responsibilities

Executes the day-to-day operations of a global phase 3 clinical study in compliance with applicable GCP/ICH guidelines, regulations, SOPs and other regulatory requirements across the globe.
Lead cross-functional study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met according to timelines, budget, quality standards and in compliance.
Responsible for leading all clinical start-up activities including feasibility, site selection/recommendation, contact and budget negotiations (site and vendor), timeline planning, supply chain, and OUS regulatory preparation.
Develop and maintain external relationships with clinical investigators and site staff. Proactively identify potential issues or problems with the sites and provide mitigation strategies.
Responsible for authoring or reviewing and/or approving clinical study documents, such as project timelines, pharmacy manuals, laboratory manuals, imaging manuals, informed consent, monitoring plans, etc.
Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and CRFs, edit checks, safety plans, DMC charter.
Work cross-functionally to coordinate the relevant and timely exchange of information to support clinical trial deliverables
Provide oversight and guidance to clinical operations teams, documents and processes to ensure best practices.
Escalates issues related to quality, timelines and budget and provides recommendations to upper management for resolution of these issues.
Regularly meet with manager to discuss overall clinical trial(s) plans, update forecasting, and potential issues/risks or recommendations.