FSP Sr. Clinical Trial Associate- Cambridge, MA

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll 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 lifechanging 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:

This is a hybrid position with 3 days in office at our Cambridge MA location.

Division Specific Information

Our global Clinical Research Group (CRG) colleagues within the Functional Service Partnership (FSP) solutions area provide support for clinical trials during feasibility study start up maintenance close out and database lock depending on the clients needs. Clientdedicated Clinical Trial Associate (FSP CTAs) work directly with clients to provide administrative and technical support by performing daytoday functions within the client organization to support clinical trial activities.

In the FSP CTA role you will represent PPD part of Thermo Fisher Scientific while working alongside the client as a partner providing a specific service. Tasks can include providing administrative and technical support to the client study team; supporting client audit readiness by ensuring client systems are accurate and up to date; providing administrative support for site activation activities; and managing assigned service providers and/or vendors. FSP CTA roles and responsibilities may vary based on sponsor needs.

A Day in the Life:

Coordinates with study team during startup maintenance and closeout activities to include collection review and submission of documents to regulatory authorities Manages and contributes to the electronic Trial Master Files (eTMF) during feasibility study startup maintenance and closeout activities (e.g. collecting and filing documents uploading study team lists adding/updating study site information study achievements and other important data) Performs eTMF quality and completion checks and initiates followup on resolutions when needed Assists with feasibility and site selection activities Manages study system access for study team site staff and service providers/vendors

Attends internal/external meetings and supports scheduling agenda and meeting minutes creation/distribution Creates maintains reviews and/or distributes study trackers forms newsletters memos to study teams sites and service providers/vendors Assists study lead with oversight of the clients service provider(s) to ensure assigned activities are completed accurately and on time (e.g. system completeness product vendor(s) and site management) Assists with administrative requests for entering purchase orders change orders and running financial reports with oversight of study lead May assist with coordination of trial/site insurance tracking of study supplies and/or shipments of drug supply Attends and/or assists in preparation for inperson meetings such as Kick Off Meetings (KOMs) Investigator Meetings (IMs) or client Face to Face meetings May assist with additional client administrative projects and tasks as needed such as supporting onboarding of new study team members

Keys to Success:

Education

• Bachelors degree preferred.

Experience

• Ideal: experience in clinical study environment within CRO or Pharmaceutical company.
• Minimum: Knowledge of the clinical study environment with a strong theorical or practical administrative organization.
• Scientific background is an asset.
• 3yr science degree and at least 23 yrs of experience as a CTA at Pharma Biotech or CRO end

Knowledge Skills Abilities

• Ability to work in a strong regulated environment within a quality management system (QMS)
• Sophisticated knowledge of software application (ex: Word Excel PowerPoint Adobe Reader )
• Ability to organize and prioritize
• Excellent communication (verbal and written) organizational and problemsolving skills
• Able to produce work in teams and within a multidisciplinary environment
• Basic Financial Knowledge must be able to work with financial tracking tools
• Knowledge of Pharmaceutical Industry R&D
• Good knowledge of the Good Clinical Practices (GCP) or other clinical study regulations

Physical Requirements/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 comprehensive and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• Travel may be required based on client needs.

#CRAdrive

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 100000 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.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.

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