Clinical Operations Manager

hace 2 semanas

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

This role is accountable for ensuring the performance and compliance of assigned protocols in a country, adhering to ICH/GCP and country regulations, company policies, quality standards, and adverse event reporting requirements.

Under the oversight of the Head Clinical Operations Managers, the person is responsible for executing and overseeing clinical trial country submissions and approvals, ensuring Site Readiness, and managing country deliverables, timelines, and results for assigned protocols.

Key Responsibilities
  • Execute and oversee clinical trial country submissions and approvals for assigned protocols, ensuring compliance with regulatory requirements.
  • Develop local language materials, including informed consents and translations, and interact with IRB/IEC and Regulatory Authorities for assigned protocols.
  • Manage country deliverables, timelines, and results for assigned protocols, ensuring quality and compliance.
  • Coordinate and liaise with CRM, CTC, CRA, and other stakeholders to ensure country deliverables are obtained for submissions, budgets, CTRAs, and local milestones.
  • Provide support and oversight to local vendors as applicable.
  • Oversee and coordinate local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving, and retention requirements, and insurance process management.
  • Ensure local regulatory compliance and ownership of local regulatory processes.
  • Required to influence investigators, external partners, and country operations, adhering to budget targets and agreed payment timelines.
  • Work in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal, and regional operations, HQ functional areas, and externally with vendors and sites, IRB/IECs, and Regulatory Authorities in submission and approval-related interactions.
  • Contribute to COM team and other Country Operations roles knowledge by acting as a process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as appropriate.
Requirements
  • 3 to 5 years of experience working with clinical studies at CROs or Pharma Industry.
  • Strong knowledge in regulatory aspects related to clinical studies.
  • English Business Proficiency.

Employee Status: Project Temps (Fixed Term)

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: No Travel Required

Flexible Work Arrangements: Hybrid

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): N/A

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