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.

• 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 (i.e. GoBalto & eTMF).

• Supports RBM activities.

• Performs administrative tasks 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.

• 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 when required.

• Ability to work in a team or independently as required

• 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 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 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