Job Description

Employment Type: Full time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office

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

This role provides administrative and technical support to the Central Lab Project Management Team, including planning, organizing, and coordinating project administration responsibilities.

Responsibilities:

• Maintains procedures, guidelines, and documentation.
• Assists with maintaining project records and ensuring that all regulatory documents are correct, processed, and approved.
• Completes data entry and supports the maintenance of database repositories.
• Assists in preparing reports and data collection for analysis.
• Supports quality review.

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 access 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.

Keys to Success

Education:

• High school diploma or equivalent required.

Experience:

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
• 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 work in a team or independently as required.
• Good organizational skills and strong attention to detail, with the ability to handle multiple tasks efficiently and effectively.
• Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency.
• Strong customer focus.
• Flexibility to prioritize workload to meet changing project timelines.
• Ability to attain and maintain a good working knowledge of applicable regulations and procedural documents for all non-clinical/clinical aspects of project implementation, execution, and closeout.
• Good English language and grammar skills.
• Good computer skills, proficient in MS Office.