Clinical Research Project Manager

hace 4 días

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

Job Description

This role is primarily accountable 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.

The Clinical Research Manager will be responsible for project management of the assigned studies, proactively planning, driving, and tracking execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution, and close out.

Key Responsibilities
  • Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
  • Responsible for performance 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 internally and externally.
  • Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
  • Performs Quality control visits as required.
  • Leads local study teams to high performance, trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert, and coordinates activities across different local country roles ensuring strong collaboration.
  • Responsible for creating and executing a local risk management plan for assigned studies, ensuring compliance with CTMS, eTMF, and other key systems in assigned studies.
  • Elevates as needed different challenges and issues to TA Head/CRD/CCQM and/or CTT (as appropriate).
  • Identifies and shares best practices across clinical trials, countries, clusters.
  • Responsible for collaboration with functional outsourcing vendors, investigators, and other external partners in assigned studies.
  • Country POC for programmatically outsourced trials for assigned protocols.
  • As a customer-facing role, this position builds business relationships and represents the company with investigators.
  • Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).
  • Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TAH, and Regional Operations.
  • Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across trials. Consults with GHH as needed.

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