Safety Committee Administrator - DSMB

Thermo Fisher Scientific•Morrisville, NC

8h•Onsite

About The Position

Join Thermo Fisher Scientific as a Safety Committee Administrator and contribute to meaningful work that impacts global health. This role provides moderate contracted project coordination and safety support for global and domestic programs, with a specific focus on Data and Safety Monitoring Boards (DSMB). You will be responsible for DSMB set-up, managing member contracts, administering payments and honoraria, coordinating meeting schedules, arranging facilities, and taking minutes for DSMB meetings. Additionally, you will oversee DSMB filing, assist with dossier building and distribution, and work with the Event Adjudication System. Collaboration with Safety Committee Specialists and internal teams is key to implementing projects, preparing contractual documents, and managing contracted services.

Requirements

High school diploma or equivalent and relevant formal academic/vocational qualification.
Technical positions may require a certificate.
Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
Strong problem-solving skills.
Ability to work independently with minimal supervision, demonstrating initiative.
Ability to build strong relationships.
Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency.
Ability to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members, and other internal staff.
Self-motivated, positive attitude with effective oral and written communication and interpersonal skills.
Excellent computer skills including MS Office (Word, Excel, PowerPoint, Access).
Ability to identify and set priorities and effectively perform a variety of tasks.
Strong attention to detail and accuracy with an orientation toward careful and meticulous work.
Ability to maintain a positive and professional demeanor in challenging circumstances.
Flexibility to reprioritize workload to meet changing project timelines.
Demonstrated ability to attain and maintain a good working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and the company's/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution, and closeout.

Nice To Haves

Working knowledge of the Event Adjudication System.

Responsibilities

Represent the DSMB Coordination Team at global and domestic committee meetings (teleconference and face-to-face), coordinating logistics and assisting with facilitation.
Interface with internal and external parties to implement contracted DSMB services, prepare contractual documents (CDAs, LOIs, Member Agreements), and coordinate approvals.
Compile, create, and submit follow-up to investigative sites.
Coordinate and facilitate project meetings, draft meeting minutes, and post blinded/unblinded minutes/materials to client portals.
Manage project-specific training and the setup, maintenance, and archival of program files to ensure audit readiness.
Identify and redact subject identifiers per local requirements, retrain sites, and escalate reoccurrences to Data Privacy.
Perform data entry into internal/external databases and tracking systems, performing system reconciliations to identify potential issues.
Oversee expenses (committee, travel, translation) and ensure timely member payment.
Support specific activities performed by the specialty committee team that require administrative support.