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Clinical Research Manager

hace 2 meses

Bogotá, Bogotá D.E., Colombia MSD A tiempo completo
Job Summary

We are seeking a highly skilled Clinical Research Manager to join our team at MSD. As a Clinical Research Manager, you will be responsible for the end-to-end performance and project management of assigned protocols in a country, ensuring compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards, and adverse event reporting requirements.

Key Responsibilities
  • Project Management: Proactively plan, drive, and track the execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution, and close-out.
  • Performance Accountability: Ensure performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards, and adverse event reporting requirements.
  • Monitoring and Quality Control: Review Monitoring Visits Reports and escalate performance issues and training needs to CRA manager and/or functional vendor and internal management as needed. Perform Quality control visits as required.
  • Team Leadership: Lead local study teams to high performance, train in the protocol other local roles, closely collaborate with and support CRAs as protocol expert, and coordinate activities across the different local country roles ensuring a strong collaboration.
  • Risk Management: Create and execute a local risk management plan for assigned studies.
  • Compliance and Systems: Ensure compliance with CTMS, eTMF, and other key systems in assigned studies.
  • Communication and Collaboration: Escalate as needed different challenges and issues to TA Head/CRD/CCQM and/or CTT (as appropriate). Identify and share best practices across clinical trials, countries, clusters. Collaborate with functional outsourcing vendors, investigators, and other external partners in assigned studies.
  • Country POC: Serve as Country POC for programmatically outsourced trials for assigned protocols.
  • Customer-Facing Role: Build business relationships and represent the Company with investigators.
  • Business Support: Support local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TAH, and Regional Operations.
  • Internal Collaboration: Collaborate internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across the trials.
Requirements
  • Experience: 5-6 years of experience in clinical research, with CRA experience preferred.
  • Education: Bachelor's degree in science (or comparable), with an advanced degree (e.g., Master's degree, MD, PhD) preferred.