Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific Inc., we are on a mission to enable our customers to make the world healthier, cleaner, and safer. We are looking for a dedicated Drug Safety Admin Associate II to join our world-class team. This role offers an outstanding opportunity to contribute to groundbreaking work in a collaborative and inclusive environment.

Essential Functions

Coordinate the timely review of protocol inquiries, serious and non-serious adverse events, diagnostics, and Data Safety Monitoring Board (DSMB) data. Track all necessary data and generate flawless reports for clients, project teams, and external vendors.Represent the DSMB/EAC Coordination Team at global and domestic committee meetings, coordinating all logistical aspects and assisting with facilitation.Collaborate with internal and external parties to implement projects, prepare Confidentiality Disclosure Agreements, Letters of Intent, and Member Agreements, ensuring all contractual documents are accurate and approved.Compile adjudication dossiers and build/submit follow-ups to investigative sites.Coordinate and facilitate project meetings, draft meeting minutes, post blinded and unblinded minutes/materials to client portals, and distribute to project teams.Manage project-specific training and the setup, maintenance, and archival of program files, ensuring audit readiness.Identify and redact subject identifiers per local requirements, train sites, and bring up reoccurrences to Data Privacy.Perform data entry into internal/external databases, tracking systems, and budget management systems; perform system reconciliations to identify potential issues.Coordinate expenses and manage translations, ensuring budget parameters are met.Answer hotline calls, coordinate department functions, and perform other duties as assigned.Support activities specific to the local office that cannot be performed elsewhere.Provide training to junior staff.

Job Complexity

Work on assignments that are semi-routine but may require deviation from accepted practice.

Job Knowledge

Apply acquired job skills and company policies and procedures to complete tasks.

Supervision Received

Follow established procedures on routine work, requiring instructions only for new assignments.

Business Relationships

Typically interact with individuals within the department and occasionally with external contacts, involving the exchange of information requiring some explanation.

Requirements

Strong problem-solving skillsAbility to work independently with minimal supervisionDemonstrated ability to foster positive relationshipsEffective in analyzing project-specific data/systems for accuracy and efficiencySkilled in acting as a liaison and communicating diplomatically with clients, management, and team membersSelf-motivated with a positive attitude and excellent communication skillsProficient in MS Office (Word, Excel, PowerPoint, Access)Ability to prioritize tasks and meet strict deadlinesStrong attention to detail and meticulous work orientationProfessional demeanor in challenging circumstancesFlexibility to adapt to changing project timelinesKnowledge of FDA Regulations, ICH Good Clinical Practices, and SOPs for non-clinical/clinical project aspects