Thermo Fisher Scientific Jobs

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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

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.

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.