Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

About us:
At Thermo Fisher Scientific, our mission is to enable our customers to make the world healthier, cleaner, and safer. With a team spanning 125,000+ colleagues worldwide, we share a common set of values - Integrity, Intensity, Innovation, and Involvement. 

Together, we accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. Our commitment to diversity and inclusion means that we value diverse experiences, backgrounds, and perspectives, creating a collaborative and inclusive environment where everyone can thrive. 

PPD, the clinical research business of Thermo Fisher Scientific, has a new opening for a Clinical Systems Operations Specialist I. This role is remotely based on the east coast of the United States and is an integral part of our global Patient First Digital Solutions, Quality Control (QC) team. The Specialist function is to coordinate the quality control of study configurations in Clinical Trial Management Systems (CTMS), eSource and other systems used in clinical trials.

What you will do:

Coordinate the global study configuration QC process. Handles all elements of quality checks at a study level, including but not limited to understanding and following SOP’s and work instructions, documentation, communication, risk identification and adherence to timelines.Identifies, researches, and resolves technical problemsEnsures study configuration accurately represents protocol requirements, study budget, and site network needs. Ensures study configuration is prepared in accordance with ICH-GCP, FDA and other applicable regulatory guidelines. Liaises on quality findings at the site level and coordinates and communicates resolutions with manager and collaborators.Works with study builders to ensure understanding of the design and study requirements prior to undertaking QC activities.Delivers study configuration QC to staff within appropriate timelines. Able to identify industry and site-level standards and implement them for study configuration design and builds. Able to handle a high workload of variable tasks, ensuring ownership and timely delivery of all assignments. Identify and communicate opportunities for process improvements back to manager

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious clinical operations experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3-5 years’ experience) Experience of medical terminology, clinical research protocols, clinical study budgets/contracts, and study documentationIn some cases an equivalency, consisting 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:

In-depth knowledge of study configuration processesAbility to exercise judgment and decision makingExcellent problem-solving abilitiesAbility to work independently and keep up with rapid changes in prioritiesOrganized with strong time management skills Knowledge of PFDS study processes and site network requirements Ability to use software to develop organized information and to provide a variety of reports. Ability to learn new software, systems and terminologyExcellent attention to detailStrong project management skills, including English communication skills.Strong collaboration skills and positive demeanorAbility to handle a high workload and ensure timely delivery

At Thermo Fisher Scientific, we are committed to fostering a healthy and harmonious workplace for our employees. We understand the importance of creating an environment that allows individuals to excel. Please see below for the required qualifications for this position, which also includes the possibility of equivalent experience:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible 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. May require as-needed travel (0-20%). 

Salary Transparency

This is a salaried role that will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Compensation will be initially discussed during the screening period, with actual compensation confirmed in writing at the time of offer.

Accessibility/Disability Access

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

EEO & Affirmative Action

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Compensation and Benefits

The salary range estimated for this position based in North Carolina is $60,000.00–$90,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

A choice of national medical and dental plans, and a national vision plan, including health incentive programs

Employee assistance and family support programs, including commuter benefits and tuition reimbursement

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, and short- and long-term disability in accordance with company policy

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

Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards