PV Coordinator

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Provides contracted project coordination and safety support on global and domestic programs with an emphasis on serious and non-serious adverse events, protocol inquiries, physician assessment of diagnostics. 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.

What You’ll Do:

• Coordinates the timely review of protocol inquiries, serious and non-serious adverse events, diagnostics; tracks all necessary data and generates reports for the client, project team and/or external vendors. 

• 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. 

• Identifies and redacts subject identifiers per local requirements, retrains sites and escalates reoccurrences to the organization's Data Privacy. 

• Performs data entry into internal/external databases, tracking systems and the organization's budget management system; performs system reconciliations to identify issues which may negatively impact project timelines.

• Oversees expenses and manages translations; ensuring budget parameters are not exceeded. 

• Coordinates department functions and performs other duties as assigned. 

• Supports any specific activities performed by the local office, which cannot be performed from elsewhere

Education and Experience Requirements:

• 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 4 years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Ability to assist in the management of a large project and to provide work direction and training to other safety support staff working on the project

• Strong critical thinking skills and ability to use problem-solving techniques applicable to constantly changing environments

• Ability to work independently with minimal supervision, demonstrating initiative

• 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 non clinical/clinical aspects of project implementation, execution and closeout

Working Conditions and Environment:

• Work is performed in a homebased environment with exposure to electrical office equipment

• Potential drives to site locations and/or travel required on rare occasion

• Majority of work computer-based

• Long varied hours required on occasion

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.