CTA

Work Schedule

Environmental Conditions

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.  

Summarized Purpose: 

Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed on schedule detailed in the organization's WPD and department guidance document. Supports training ofnew staff andparticipates in departmental initiatives to support processimprovements/enhancements.  

Discover Impactful Work: 

Clinical Research Group is dedicatedin improving health. It starts as an idea to cure. It becomes a life saved. All in-between,it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our dedicated,forward-thinking and upbeat teams.  

Key responsibilities: 

• According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix. 

• Performs department, Internal, Country and Investigator file reviews as assigned. 

• Ensuresallocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads and line manager asappropriate. 

• Supports the maintenance of study specific documentation and global support with specific systems,tools and trackers. 

• Provides system support (i.e.GoBalto & eTMF). 

• Supports RBM activities. 

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

• Supports scheduling of client and/or internal meetings with completion of related meeting minutes. 

• Reviews and tracks local regulatory documents. 

• Transmits documents to client and centralized IRB/IEC. 

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

• Maintains vendor trackers. 

• Assists with coordination,compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites. 

• Assists with study-specific translation materials and translation QC upon request. 

• May attend Kick off meeting and take notes whenrequired. 

Keys to Success:  

Education 

Bachelor's degree preferred. 

Previousexperience thatprovides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years). 

In somecases an equivalency, consisting of a combination 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, Abilities 

Responsible for adhering to Good Clinical Practices, country specific regulations, CRG services /Client Standard Operating Procedures and Working Practice Documents regulations for allnon-clinical/clinical aspects of project implementation, execution, and closeout 

• Ability to work in a team or independently asrequired 

• Ability to handle multiple tasks efficiently 

• Ability to analyze project-specific data/systems to ensure accuracy and efficiency 

• With flexibility and adaptability to reprioritize workload andprovide efficient support to meet changing project timelines 

• Ability toattain and maintain a good understanding of applicable Country Regulations,ICH and organization/Client SOPs and WPDs and closeout 

• Strong English language and grammar skills and proficient local language skills as needed 

• Strong IT skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems 

• Ability to complete CRG clinical training program 

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 technologicalinnovation 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 discriminateon 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 requiringaccommodations in the job application process. For example, this may include individualsrequiringassistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, orassisting a person with a disability, and require accessibilityassistance oran accommodation to apply for one of our jobs, pleasesubmit 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 accessibilityassistance oran accommodation in the job application process. Messages left for other purposes, such as not being able to getinto the career website, following up on an application, or other non-disability related technical issues will not receive a response.