**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Summarized Purpose**:
Provides contracted project coordination and safety support on general and domestic programs with an emphasis on serious and non-serious adverse events, protocol inquiries, physician assessment of diagnostics, Data and Safety Monitoring Boards and Endpoint Adjudication Committees. In collaboration with Safety Specialists and Medical Monitors, liaises and establishes effective relationships with internal functional team members to implement projects, prepare contractual documents, coordinate and facilitate meetings and accurately manage all incoming safety documentation.
**Essential Functions**
- Coordinates the timely review of protocol inquiries, serious and non-serious
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 logístical 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.
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.
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).
Knowledge, Skills and Abilities:
Strong problem solving skills
Ability to work independently with mínimal supervision, demonstrating initative
Ability to build strong relationships
Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
Ability to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members and other internal staff
Self-motivated, positive attitude with effective oral and written communication and interpersonal skills
Excellent computer skills to include: MS Office (Word, Excel, PowerPoint, Access)
Ability to identify and set priorities and effectively perform a variety of tasks simultaneously with strict deadlines
Strong attention to detail and accuracy with orientation toward careful and meticulous work
Ability to maintain a positive and professional demeanor in challenging circumstances
Flexibility to reprioritize workload to meet changing project timelines
Demonstrated ability to attain and maintain a good working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and the organization's/Client SOPs and WPDs for all nonclinical/clinical aspects of project implementation, execution and closeout
Management Role:
No management responsibility
Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment
Potential drives to site locations and/or travel required on rare occasion

📌 Safety Admin (México)
🏢 Thermo Fisher Scientific
📍 México