Job Description

Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeAt Thermo Fisher Scientific, you\xe2\x80\x99ll 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 \xe2\x80\x93 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. Provides administrative support for site activation activities. Supports training of new staff and may act as a buddy during onboarding phase. Participates in departmental initiatives to support process improvements/enhancements.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.
• Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads and line manager, as appropriate.
• Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers.
• Provides system support and document tracking (i.e. Activate & eTMF).
• Supports RBM activities.
• 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, performing mass mailings and communications as needed, providing documents and reports to internal team members.
• 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.
• Trains new personnel in processes and systems.
• May attend Kick off meeting and take notes when required.
• May support start-up team to work with sites to collect required essential documents, in preparation for ethics or regulatory submission, including uploading of documents into relevant systems and portals.
• May support scheduling of client and/or internal meetings with completion of related meeting minutes.
• Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.\xe2\x80\x8b

Keys to SuccessEducation and Experience:
Bachelor\'s degree preferred. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to
1 year).
In some cases 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:

• Ability to work in a team or independently as required
• Good organizational skills and strong attention to detail, with ability to handle multiple tasks efficiently and effectively
• Ability to analyze project-specific data/systems to ensure accuracy and efficiency
• Flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
• Ability to attain and maintain a good understanding of applicable Country Regulations, ICH and organization/Client SOPs and WPDs for all nonclinical/clinical aspects of project implementation, execution and closeout
• Good oral and written English language communication 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

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 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 at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today!
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.

Thermo Fisher Scientific