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Safety Committee Administrator
Thermo Fisher Scientific. Provide moderate contracted project coordination and safety support for global and domestic programs, especially DSMB and Endpoint Adjudication Committees .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates strong project coordination and safety support capabilities, with expertise in managing DSMB and Endpoint Adjudication Committees. Proficient in data analysis, effective communication, and adherence to FDA regulations and ICH Good Clinical Practices.
Highest-signal resume keywords
Project CoordinationData AnalysisEffective CommunicationFDA Regulations KnowledgeICH Good Clinical Practices
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data EntrySystem ReconciliationMeeting FacilitationContract AdministrationDocument ManagementProject TrainingConfidentiality Disclosure AgreementsMeeting Minutes PreparationLogistics CoordinationFile Maintenance
Soft Skills
Problem-SolvingRelationship BuildingInitiativeAttention to DetailFlexibility
Tools & Technologies
MS OfficeClient Portals
Certifications & Qualifications
Relevant Formal Academic QualificationTechnical Certificate (if applicable)
Industry Keywords
DSMBEndpoint Adjudication CommitteesGood Clinical PracticesFDA RegulationsSOPsWPDs
About the role
Key responsibilities & impact- Provide moderate contracted project coordination and safety support for global and domestic programs, especially DSMB and Endpoint Adjudication Committees
- Set up DSMB/CEC committees, execute and track member contracts, administer payments and honoraria, and coordinate meeting schedules
- Arrange meeting facilities, attend meetings, and complete meeting minutes
- Oversee DSMB/CEC filing, support dossier building and distribution, and obtain and track adjudication documents
- Represent the DSMB/EAC Coordination Team at global and domestic committee meetings via teleconference and face-to-face formats
- Coordinate logistics and assist with meeting facilitation alongside clients, committee members, vendors and project teams
- Prepare and review Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements, coordinating approvals
- Compile, create and submit follow-up to investigative sites
- Coordinate project meetings, draft minutes, and distribute blinded/unblinded materials through client portals
- Manage project training and program file setup, maintenance and archival
- Identify and redact subject identifiers, retrain sites and escalate recurring issues to Data Privacy
- Perform data entry and system reconciliations to identify timeline-impacting issues
- Oversee committee, travel and translation expenses and escalate issues for timely payment
- Support specialty committee team activities that can be assisted by administrative support
- Liaise with internal functional teams to implement projects and coordinate contracted services
Requirements
What you’ll need- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- Technical positions may require a certificate
- At least 2 years of previous experience providing relevant knowledge, skills, and abilities
- Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
- Strong problem-solving skills
- Ability to work independently with minimal supervision and demonstrate initiative
- Ability to build strong relationships
- Ability to analyze project-specific data/systems for accuracy and efficiency
- Effective liaison and respectful, diplomatic communication with clients, management, project team members and internal staff
- Effective oral and written communication and interpersonal skills
- Excellent computer skills, including MS Office (Word, Excel, PowerPoint, Access)
- Ability to prioritize and perform multiple tasks under strict deadlines
- Strong attention to detail and accuracy
- Flexibility to reprioritize workload according to changing project timelines
- Working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, company/client SOPs and WPDs
- Potential ability to travel occasionally and drive to site locations
Benefits
Comp & perks- Global team environment
- Career development opportunities
- Health and wellbeing support
- Healthy and balanced work environment
- Collaboration and professional development opportunities