PV Coordinator

Position Overview

• Location Type: [Not specified]
• Job Type: Full-time
• Work Schedule: Standard (Mon-Fri)
• Environmental Conditions: Office
• Company: Thermo Fisher Scientific Inc.
• Mission: To enable our customers to make the world healthier, cleaner, and safer.

This role offers an outstanding opportunity to contribute to groundbreaking work in a collaborative and inclusive environment as a Drug Safety Admin Associate II.

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 unblin ded 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 skills
• Ability to work independently with minimal supervision
• Demonstrated ability to foster positive relationships
• Effective in analyzing project-specific data/systems for accuracy and efficiency
• Skilled in acting as a liaison and communicating diplomatically with clients, management, and team members
• Self-motivated with a positive attitude and excellent communication skills
• Proficient in MS Office (Word, Excel, PowerPoint, Access)
• Ability to prioritize tasks and meet strict deadlines
• Strong attention to detail and meticulous work orientation
• Professional demeanor in challenging circumstances
• Flexibility to adapt to changing project timelines
• Knowledge of FDA Regulations, ICH Good Clinical Practices, and SOPs for non-clinical/clinical project aspects