Job Description: DSMB/EAC Coordinator

Position Overview

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.

Employment Type

• Full time

Work Schedule

• Standard (Mon-Fri)

Environmental Conditions

• Office

Responsibilities

• Tracks all necessary data for adverse events, diagnostics, and Data Safety Monitoring Board (DSMB) 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.
• Reviews all contractual documents for accuracy and coordinates 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 them to internal and external project teams.
• Manages project-specific training and the set-up, maintenance, and archival of program files, ensuring Pharmacovigilance (PV) remains audit-ready.
• Identifies and redacts subject identifiers per local requirements, retrains sites, and escalates reoccurrences to the organization's Data Privacy team.
• Performs data entry into internal/external databases, tracking systems, and the organization's budget management system.
• Performs system reconciliations to identify issues that may negatively 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 that 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 occasions.
• Majority of work is computer-based.
• Long varied hours required on occasion.