Project Assistant II

at  Thermo Fisher Scientific

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.
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 Sample Management Operation Team: Coordinates, oversees, and completes administrative functions on assigned tasks and departmental projects. This includes, but not limited to, review and create forecasting of scheduled tasks as Shipment Schedules, Daily Task List, Monthly Inventory, REES management. Provides administrative and technical support to 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. This role 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:

• Coordinate internal and external communication related to the assigned task/project and act as a point of contact for all Sample Management team members related to the assigned duties.
• Coordinate Requisition and Clinical form support. Perform review and support data verification of paper study documentation.
• Provides support in preparation of internal and external audits. Follow-up on the investigating and resolving internal/external audit findings; events and CAPA management; providing re-training and ensures closure of all open issues. Possesses the ability to anticipate the needs of the Manager/ Director and to ensure departmental success.
• Participate in small and middle size special projects to gain efficiencies and changes in Sample Management Operations. Supports Sample Coordinators by providing training when process improvements are implemented.
• Maintains quality metrics; identify trends and submits relevant data to the Manager/ Director.
• Coordinates and performs sample management administrative tasks.
• Performs sample management lab checklists.
• 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.
• 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.
• 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 Sample management 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) or equivalent combination of education, training, & experience.
• Added value experience within the Sample Management department or an equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.

KNOWLEDGE, SKILLS, ABILITIES

• Maintains confidentiality
• Demonstrates positive presence
• Maintains personal accountability
• Critical thinking and problem-solving skills
• Added value: Knowledge of PPD’s Preclarus® central lab database
  Working environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to lift and move objects of 15 to 40 pounds
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• Exposure to fluctuating and/or extreme temperatures on rare occasions

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to lift and move objects of 15 to 40 pounds
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• Exposure to fluctuating and/or extreme temperatures on rare occasion