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

This role is a remote based role that will sit in Poland. It is an integral part of our global Patient First Digital Solutions, Quality Control (QC) team within the PPD clinical research portfolio.

Discover Impactful Work:

Join Thermo Fisher Scientific as a CRG-Clinical Systems Operations Specialist I to coordinate the quality control of study configurations in Clinical Trial Management Systems (CTMS), eSource and other systems used in clinical trials.

A day in the Life:

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 study level quality findings and coordinates and communicates resolutions with manager and collaborators, as needed.Liaises with study builders to ensure understanding of the build design and study requirements prior to undertaking QC activities.Liaises with the system builders and/or customers, as necessary on configuration uncertainties and/or clarifications.Delivers study configuration QC to staff efficiently and 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 managerResearch issues, track metrics, and maintain reports and documentation related to quality and compliance activities.Administer quality and compliance processes and ensure appropriate execution and completion.Contribute to projects and process/quality improvement initiatives.Communicate with representatives from other departments to ensure quality and timelines are maintained with respects to compliance activities. (e.g., client audits, CAPA and/or procedural documents)Work on problems of moderate cope where analysis of situations or data requires a review of a variety of factors.Develop professional expertise, apply company policies and procedures to resolve a variety of issues.

Keys to Success:

Proficiency in primary software used by the company and ability to learn new software, systems and terminologyExcellent attention to detailConfirmed project management skills, including communication and organizationAbility to absorb and retain knowledge of work applications used to develop study configuration for clinical sitesStrong collaboration skills and positive demeanorAbility to handle a high workload and ensure timely delivery

Education

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years).

Experience

Experience with ICH-GCP, FDA, and other regulatory guidelinesExperience of medical terminology, clinical research protocols, clinical study budgets/contracts, and study documentation is preferred.

Knowledge, Skills, 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 skillsKnowledge of PFDS study processes and site network requirementsAbility to use software to develop organized information and to provide a variety of reportsHighlight issues which could improve efficiency and processes

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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

Physical Requirements / Work Environment

This role involves standard office and/or clinical environments with occasional travel for meetings and training sessions. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands and wrists.

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.