13 ago
|
Thermo Fisher Scientific
|
Ciudad de México
13 ago
Thermo Fisher Scientific
Ciudad de México
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Senior Central Review Manager – Make an Impact at the Forefront of
Innovation
We have successfully supported the top 50 pharmaceutical companies and more than
750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5
years.
As part of our expert team, you’ll have the opportunity to ensure operational
excellence that makes a real difference in organizational performance. As a
Senior Central Review Manager, you will perform centralized report review and
approval of PSA, SI, ME, and CO reports on assigned projects in accordance with
procedural documents and guidelines. You will provide training to new Central
Review Managers (CRMs) and may act as the lead report reviewer on allocated
projects, serving as the central liaison between the CRM team and Clinical Leads
(CLs) or Project Leads (PLs).
What You’ll Do:
• Performs review of clinical monitoring visit reports for allocated projects
ensuring consistency across protocols and/or regions and escalates any protocol,
site, and/or CRA issues or trends noted during the report review process to CL.
• Liaises with clinical monitoring staff for prompt trip report review
submission and approval as per the stipulated timelines of CRG and/or the
Sponsor. Plays an active role on the project team to help ensure compliance with
monitoring visit report expectations.
• Reviews and customizes the Monitoring Report Templates for allocated projects.
• Evaluates PI oversight (e.g., protocol adherence), subject safety and study
processes in order to assess site’s ability to conduct study, as ascertained
from information noted in monitoring visit reports and associated electronic
data systems.
• Attends applicable internal Project meetings.
• Provides input of forecast estimates for report review activities.
• Provides trial MER status tracking and progress update reports to CL/CRA as
required.
• Contributes to company
📌 Central Review Manager (Ciudad de México)
🏢 Thermo Fisher Scientific
📍 Ciudad de México