Safety Admin

Work Schedule

Environmental Conditions

Job Description

At 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.
Essential Functions:
- adverse events, diagnostics and Data Safety Monitoring Board data; tracks all necessary data and generates reports for the client, project team and/or external vendors.
- Represents the organization's 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 project team, coordinating all logistical aspects and assisting with facilitation.
- Interfaces with various internal and external parties to implement projects, prepares 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.
- Compiles adjudication dossiers and creates/submits follow-up to investigative sites.
- Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and unblinded minutes/materials to client portals and distributes to internal and external project teams.
- Manages project specific training and the set-up, maintenance and archival of program files; ensuring PV remains audit ready.
- Identifies and redacts subject identifiers per local requirements, retrains sites and escalates reoccurrences to the organization's Data Privacy.
- Performs data entry into internal/external datases, tracking systems and the organization's budget management system; performs system reconciliations to identify issues which may negativley impact project timelines.
- Oversees expenses and manages translations; ensuring budget parameters are not exceeded. Answers incoming hotline calls, coordinates department functions and performs other duties as assigned.
- Supports any specific activities performed by the local office, which cannot be performed from elsewhere.
- Provides training to junior staff.
Qualifications:
Education and Experience:
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).
Working Conditions and Environment:
- Work is performed in an office environment with exposure to electrical office equipment
- Potential aims to site locations and/or travel required on rare occasion
- Majority of work computer-based
- Long varied hours required on occasion