Safety Committee Administrator

Thermo Fisher Scientific•Morrisville, NC

4d•Onsite

About The Position

The Safety Committee Administrator provides moderate contracted project coordination and safety support for global and domestic programs, primarily involving Data and Safety Monitoring Boards (DSMBs) and Endpoint Adjudication Committees (EACs). The role coordinates committee setup, member contracts and payments, meeting scheduling and logistics, minutes, filing, dossier preparation and distribution, and adjudication-related documents. The administrator works with Safety Committee Specialists and internal and external stakeholders to implement projects, prepare contractual documents, facilitate meetings, and manage contracted services.

Requirements

High school or secondary school diploma or equivalent, plus a relevant formal academic or vocational qualification.
At least 2 years of comparable experience, or an accepted combination of appropriate education, training, and directly related experience.
Strong problem-solving skills and the ability to work independently with minimal supervision and initiative.
Ability to build strong relationships and communicate respectfully and diplomatically with clients, management, project team members, and other internal staff.
Ability to analyze project-specific data and systems for accuracy and efficiency.
Self-motivation, a positive attitude, and effective oral, written, and interpersonal communication skills.
Excellent computer skills, including Microsoft Word, Excel, PowerPoint, and Access.
Ability to set priorities and manage multiple tasks simultaneously under strict deadlines.
Strong attention to detail and accuracy, with a careful and meticulous approach to work.
Ability to maintain a positive, professional demeanor in challenging circumstances and reprioritize work as project timelines change.
Ability to attain and maintain working knowledge of applicable FDA regulations, ICH Good Clinical Practices, and company and client SOPs and WPDs for clinical and nonclinical project implementation, execution, and closeout.

Responsibilities

Represent the DSMB/EAC Coordination Team at global and domestic committee meetings, remotely and in person, and coordinate meeting logistics alongside clients, board members, vendors, and project teams.
Implement contracted DSMB and adjudication services, prepare confidentiality disclosure agreements, letters of intent, and member agreements, review documents for accuracy, and coordinate approvals.
Compile, create, and submit follow-up materials to investigative sites.
Coordinate and facilitate project meetings; draft minutes; post blinded and unblinded minutes and materials to client portals; and distribute them to project teams.
Manage project-specific training and the setup, maintenance, and archiving of program files to keep PV audit ready.
Identify and redact subject identifiers according to local requirements, retrain sites, and escalate recurring issues to Data Privacy.
Enter data into internal and external databases and tracking systems, and reconcile systems to identify issues that could affect project timelines.
Oversee committee, travel, and translation expenses, escalating issues as needed to ensure timely member payment.
Support administrative activities performed by the specialty committee team.
Set up DSMB/EAC members’ contracts and track their execution; administer member payment setup and honoraria management.
Poll committee members and client contacts to schedule meetings, arrange meeting facilities as needed, and attend and take minutes for contracted DSMB/CEC meetings.
Oversee DSMB/CEC filing, assist Safety Committee Specialists with dossier building and distribution, and obtain and track adjudication documents for dossiers.
Build effective working relationships with internal functional team members and other stakeholders to implement projects and manage contracted services.