Clin Ops Delivery Associate I at Thermo Fisher Scientific

Job Description

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $24 billion and approximately 70, employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity.

Summary

As a Clinical Trial Coordinator, you will provide administrative and technical support to the Project Team. You will support audit readiness by ensuring files are reviewed on schedule detailed in the organization’s WPD and department guidance document.

Keys to Success:

Coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix. Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system. Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads. Supports the maintenance of study specific documentation and systems including but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system. Provides system support (i.e. GoBalto & 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. Supports scheduling of client and/or internal meetings. 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.

Requirements

Education

Diploma or equivalent and relevant formal academic / vocational qualification. Bachelor’s degree preferred. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).

​​​​​​​ Knowledge, Skills, Abilities

Ability to work in a team or independently as required Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency Strong customer focus Flexibility to reprioritize workload to meet changing project timelines Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout Fluency in English and Portuguese is essential Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems Ability to successfully complete PPD clinical training program Self-motivated, positive attitude and good interpersonal skills