**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** 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:** 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 client’s needs. Client-dedicated Clinical Trial Associate (FSP CTAs) work directly with clients to provide administrative and technical support by performing day-to-day 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 follow-up 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 client’s 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 in-person 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** + Bachelor’s 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. + 3-yr science degree and at least 2-3 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 problem-solving skills + Able to produce work in teams and within a multi-disciplinary 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 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. Apply today! http://jobs.thermofisher.com 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. Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process. *This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response. 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.