Head of Site Management and Monitoring

hace 2 meses

Santiago de Chile MSD A tiempo completo

This position is responsible for key tasks related to site management, territory development, and country study support. It plays a critical role in the local Global Clinical Trial Operations (GCTO) country management team and supports the country or cluster Clinical Research Director or Region Head in executing the Global Clinical Trial Operations strategy in the territory. The position will directly impact the country, cluster, or region's ability to reach business targets and objectives.

Under the oversight of the Clinical Research Director or Region Head, the individual is responsible for monitoring resource management, capacity assessments of the Clinical Research Associate workload, and the overall quality of monitoring deliverables. The role has between three and twelve direct reports (Clinical Research Associate Managers) and indirect oversight of forty to one hundred fifty Clinical Research Associates.

As a line manager, your role is critical in developing key talents in the organization to ensure a pool of success in critical roles. The individual is 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) guidelines. Additionally, the individual will collaborate at the local level internally with the Country Therapeutic Area director, Monitoring Excellence, Vendor Management, and can represent the Clinical Research Director in local management if required. Externally, the role involves collaboration with investigators, functional resourcing vendors, regulators, and the pharmaceutical industry.

Responsibilities include, but are not limited to:

- Responsible for 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 (our company's and also partners). The individual must ensure metrics are met at expected standards.
- Accountable for resource and talent management of the organization’s Clinical Research Associates and Clinical Research Associate managers in the territory. This includes managing the performance of Clinical Research Associate managers, conducting performance evaluations, encouraging high performance towards agreed aims and objectives, addressing low performance situations, ensuring development needs are met, and supporting recruiting efforts (including interviews and hiring).
- 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.
- Collaborating externally with investigators, functional resourcing vendors, regulators, and the pharmaceutical industry.
- Overseeing and managing local vendors and partners to ensure consistency across the country monitoring organization. The individual will work closely with Project Leaders and Clinical Research Associate managers to ensure consistency across all monitoring resources and will also be accountable for quality and compliance in the monitoring function and the development and execution of strategic quality initiatives within this function.
- In conjunction with Monitoring Excellence, 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 and working closely with other Global Clinical Trial Operations management roles, headquarters teams, quality compliance, finance, information technology, and human resources.
- Being 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 across Global Clinical Development and Global Clinical Trial Operations.

This position and its direct reports significantly impact the ability to effectively conduct clinical studies and develop the pipeline while maintaining regulatory requirements and compliance. The individual will directly influence the country's ability to meet business targets and objectives while building productive collaborations with both internal and external business partners.

**CORE Competency Expectations**:

- Business and financial acumen
- Strategic thinking
- Ability to think cross-functionally and work across boundaries internationally
- Early identification of problems, conflicts, and opportunities, with the ability to lead, analyze mitigation plans, and driv

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