Safety Committee Administrator

Thermo Fisher Scientific • Morrisville, NC

6d • Onsite

About The Position

Join Thermo Fisher Scientific and contribute to a global mission of making the world healthier, cleaner, and safer. We empower our teams with the resources for individual career growth and to advance science through research, development, and delivery of life-changing therapies. With a significant presence in clinical research across numerous countries and the development of innovative frameworks, our work impacts laboratory services, digital solutions, and decentralized clinical trials. Your dedication to quality and accuracy will enhance health outcomes for individuals and communities, both now and in the future. We have a proven track record of supporting major pharmaceutical companies and biotechs, managing thousands of clinical trials globally.

Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Technical positions may require a certificate
• Previous experience that provides 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
• Know how 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 to include: MS Office (Word, Excel, PowerPoint, Access)
• Ability to identify and set priorities and effectively perform a variety of tasks simultaneously with strict deadlines
• Strong attention to detail and accuracy with 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

• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Responsibilities

• Provides moderate contracted project coordination and safety support on global and domestic programs with an emphasis on Data and Safety Monitoring Boards (DSMB) and Endpoint Adjudication Committees (EAC).
• Performs DSMB/EAC set-up, member contract execution and tracking.
• Administers member payment set up, member honoraria management and oversight, polls committee members and client contacts for meeting dates and times.
• Arranges meeting facilities as needed for all contracted meetings and attends and completes meeting minutes for DSMB/CEC meetings as contracted.
• Provides oversight for all DSMB/CEC filing, assists the Safety Committee Specialist with dossier building and distribution and has a working knowledge of the Event Adjudication System.
• Obtains and tracks adjudication specific documents for inclusion into dossier.
• In collaboration with Safety Committee Specialists, liaises and establishes effective relationships with internal functional team members to implement projects, prepare contractual documents, coordinate and facilitate meetings and accurately manage all contracted services for DSMB/EAC.
• Represent the DSMB/EAC Coordination Team at global and domestic committee meetings (both via teleconference and face-to-face) alongside the client, board members, third party vendors and the company's project team, coordinating all logistical aspects and assisting with facilitation.
• Interface with various internal and external parties to implement contracted DSMB / Adjudication services for projects, prepare Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements based on contractual considerations; reviewing all contractual documents for accuracy and coordinating internal and external approvals.
• Compile/create/submit follow-up to investigative sites.
• Coordinate/facilitate project meetings, draft meeting minutes, post blinded and unblinded minutes/materials to client portals and distribute to internal and external project teams.
• Manage project specific training and the set-up, maintenance and archival of program files; ensuring PV remains audit ready.
• Identify and redact subject identifiers per local requirements, retrain sites and escalate reoccurrences to the company's Data Privacy.
• Perform data entry into internal/external databases, tracking systems; perform system reconciliations to identify issues which may negatively impact project timelines.
• Oversee expenses including committee, travel or translation expenses ensuring proper escalation as needed for timely member payment.
• Support any specific activities performed by the specialty committee team, which can be assisted by administrative support.

Benefits

• Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED