Thermo Fisher Scientific is a global biotechnology product development company whose mission is to make the world healthier, cleaner, and safer. Thermo Fisher Scientific leads a gl
Amendment Implementation Coordinator
Location
Mexico
Posted
38 days ago
Salary
0
Seniority
Senior
No structured requirement data.
Job Description
Amendment Implementation Coordinator
Thermo Fisher Scientific
Title: Amendment Implementation Coordinator Location: Remote Mexico Full time Remote Summarized Purpose: Provides amendment support to project teams by performing various administrative activities; may perform ad hoc site activation tasks. Essential Functions - Supports amendment activities. - Assists with technical and administrative support for projects in collaboration with internal departments and project team members. - Attends amendment strategy meeting, as applicable and required. - Develops templates (e.g., Essential Documents Checklist, welcome email) at a study level following instruction from a project team. - Ensures that trial status information relating to site activation activities and amendments is tracked in applicable systems and accurately maintained in database(s) at all times. - Supports updates to the Essential Documents Checklist based on each amendment. - Supports eTMF compliance (study, country, and site levels) by identifying/highlighting gaps and following up with project team members. - Supports start up and amendments conference calls; documents, completes, and distributes meeting minutes from internal/client meetings, as applicable. - Requests resources in Clarity and follows up on assignments. - Tracks amended documents in CTMS. - Reviews timesheet reports related to amendments task code and follows up with individuals who have overburn hours related to amendments to determine the rationale and requests additional hours. - May assist with audit and inspection preparation. - May support preparation and distribution of the Amendment Progress Report and other applicable study reports to project teams to act on compliance gaps as applicable, directly in systems, providing a deadline for feedback. Education & Experience - High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification. - Previous experience that provides the knowledge, skills, and abilities to perform the job. - 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.
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