Safety Committee Administrator

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Safety Committee AdministratorAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.The Safety Committee Admin 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.What You'll Do: • 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. Education and Experience 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). …