Job Description

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.

Location/Division Specific Information

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Discover Impactful Work

Provides administrative and technical support to the Central Lab Project Team including planning, organizing and coordinating responsibilities of project administration. Maintains procedures, guidelines and documentation. Maintains project records and ensures that all regulatory documents are correct, processed and approved. Completes data entry and maintenance of data base repositories. Assists in preparing reports and data collection for analysis. Supports quality review and audit readiness.

A Day in the Life

• Assists with review, coordination and compilation of files and other materials.
• Distributes project documents and supplies.
• Processes and tracks local regulatory, study specific or department documents.
• Performs file review.
• Organizes and maintains correspondence files and other departmental records.
• Analyzes and reconciles project documents, metrics and findings reports within specified timelines.
• Assists with clarification and resolution of findings related to documentation.
• May assist with translation materials and translation QC upon request.
• Composes, copies and distributes communications, reports, documents and forms.
• Performs mass mailings and communications.
• Maintains vendor trackers.
• Provides accesses to company, client and vendor systems.
• Processes local payments (translations, EC/IEC, other local vendors, etc.)
• Assists on project management ad-hoc activities, producing reports or on study plan edition.
• Coordinates team conference calls and completes and distributes meeting minutes from internal/client/vendor meetings as applicable.
• Maintains a working knowledge of applicable GCPs, organization and client SOPs and/or protocol-related specifics through professional career development to ensure continued compliance.
• Serves as a resource to the project team.

Keys to Success

Education

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
• Technical positions may require a certificate.

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 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, Abilities

• Self-motivated, positive attitude with effective oral and written communication and interpersonal skills.
• Ability to work in a team or independently as required.
• Good organizational skills and strong attention to detail, with demonstrated ability to handle multiple tasks efficiently and effectively.
• Ability to effectively analyze and update project.

Employment Type

Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office