Site Management and Operations Director

hace 5 horas

Santiago, Metropolitana, Chile MSD A tiempo completo

This role plays a critical part in the local Global Clinical Trial Operations (GCTO) country management team. The position is responsible for key tasks related to site management, territory development, and country study support. It supports the country or cluster Clinical Research Director or Region Head in executing the Global Clinical Trial Operations strategy in the territory.

The position has direct oversight of resource management, capacity assessments of the Clinical Research Associate workload, and the overall quality of monitoring deliverables. As a line manager, you will have between three and twelve direct reports (Clinical Research Associate Managers) and indirect oversight of forty to one hundred fifty Clinical Research Associates.

As a leader, your role is crucial in developing key talents within the organization to ensure a pool of success in critical roles. You are expected to ensure excellent study performance with strict adherence to local regulations, standard operating procedures, and International Council for Harmonisation Good Clinical Practice guidelines (ICH GCP). Collaboration at the local level involves working with the Country Therapeutic Area director, Monitoring Excellence, Vendor Management, and representing the Clinical Research Director if required. Externally, the role requires collaboration with investigators, functional resourcing vendors, regulators, and the pharmaceutical industry.

Key responsibilities include:

  • Managing country or cluster monitoring resource management, conducting capacity assessments of Clinical Research Associate workload, and ensuring the overall quality of monitoring deliverables from the area across all projects and monitoring resources.
  • Accountable for resource and talent management of the organization's Clinical Research Associates and Clinical Research Associate managers in the territory.
  • Collaborating internally with Country Therapeutic Area Directors, Clinical Research Directors, Clinical Research Associate managers, Monitoring Excellence, Vendor Management, and Vendor Strategy to develop and build the territory of principal investigators and sites.
  • Overseeing and managing local vendors and partners to ensure consistency across the country monitoring organization.
  • Developing monitoring resourcing strategies in the country or cluster with vendors and Clinical Research Directors to meet current and future resource demands.
  • Working with vendors to position and place Clinical Research Associates for optimal efficacy and effectiveness.
  • Being accountable for the overall oversight of all Functional Service Provider Clinical Research Associates.
  • Collaborating closely with other Global Clinical Trial Operations management roles, headquarters teams, quality compliance, finance, information technology, and human resources.
  • Participating as a member of the local Leadership Team for Global Clinical Trial Operations and working closely with the country or cluster Leadership team, sponsors, and supporting strategic initiatives.

This position significantly impacts the ability to effectively conduct clinical studies and develop the pipeline while maintaining regulatory requirements and compliance. Your influence will directly affect the country's ability to meet business targets and objectives while building productive collaborations with internal and external business partners.

In this role, you will contribute to MSD's mission by leading a team that ensures the highest standards of clinical research operations.

We estimate the annual salary range for this position to be approximately $120,000 - $160,000, depending on location and experience.

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