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/Division Specific Information

FSP (Functional Service Partnership) is a partnership between Thermo Fisher Scientific and our clients. In this position, employees will be sourced to work with a specific client. This home-based, remote position requires candidates to currently live in one of the following states: IA, IL, IN, KS, MI, MN, MO, ND, NE, OK, SD, TX, WI, CT, DC, DE, KY, MA, MD, ME, NC, NH, NJ, NY, OH, PA, RI, TN, VA, VT, WV, AL, AR, FL, GA, LA, MS, SC.

Discover Impactful Work:

Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed, aids the development of site activation, and develops collaborative relationships with investigators and site personnel. Supports training of new staff and participates in departmental initiatives to aid in process improvements/enhancements.

A day in the Life:

• Coordinates, oversees and completes functions on assigned trial(s) activities.

• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings. Proactively communicates any risks to project leads and line manager as appropriate.

• Performs administrative tasks on assigned trials including but not limited to timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.

• Reviews and tracks local regulatory documents. Maintains vendor trackers.

• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.

• Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.

• Ensures that trial status information relating to activities is accurately maintained in the database and current at all times.

• Trains new personnel in processes and systems.

• Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s).

• May support scheduling and organization of client and/or internal meetings with completion of related meeting minutes.

• May assist with start-up activities and support start-up team in Regulatory submissions.

• Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.

• May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites. Harnesses this knowledge base when performing local tiering of sites.

Education

Bachelor's degree preferred. In some cases, additional vocational qualifications may be considered in lieu of a degree.

Experience

Previous experience that provides the knowledge, skills, and abilities to perform the job (at least 2 years). Strong experience in CTMS systems and eTMF systems (specifically Veeva Vault).

Knowledge, Skills, Abilities

• Strong organizational skills and attention to detail, with proven track record to handle multiple tasks efficiently and effectively

• Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency

• Strong customer focus

• Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines

• Good presentation skills

• Excellent digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems

• Self-motivated, positive attitude with effective strong interpersonal skills

• Effective oral and written English communication skills, with the ability to communicate effectively with medical personnel

• Excellent interpersonal skills

• Strong attention to detail and quality of documentation

• Good digital literacy and the ability to learn appropriate software

• Basic medical/therapeutic area and medical terminology knowledge

• Ability to work in a team environment or independently.

• Ability to attain and maintain a solid understanding of GCP and applicable SOPs

• Proven flexibility and adaptability

• A proven relationship builder

• Ability to manage risk and perform risk escalation appropriately

Physical Requirements / Work Environment

Thermo Fisher Scientific values the health and well-being 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:

• Work is performed in a home office environment with exposure to electrical office equipment.

Physical Requirements:

• Frequently stationary for 4-6 hours per day.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Ability to communicate so others will understand; with the ability to listen to and understand information and ideas.

• May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.

• Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.

• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

The salary range estimated for this position is $20.00 hourly - $36.00 hourly, dependent on leveling. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.

We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:

• A choice of national medical and dental plans, and a national vision plan

• A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA)

• Tax-advantaged savings and spending accounts and commuter benefits

• Employee assistance program

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

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.