Head, Site Management and Monitoring - Remote

This position is responsible for key tasks related to site management, territory development and country study support. It is a critical role in the local GCTO country management team and supports the country/cluster CRD or Region Head in executing GCTO strategy in the territory. The position will directly impact country/cluster/region ability to reach business targets and objectives.

Under the oversight of the CRD or Region Head, the person is responsible for monitoring resource management, capacity assessments of CRA workload and overall quality of monitoring deliverables. The role has 3 to 12 direct reports (CRA manager) and has indirect oversight of 40 to 150 CRAs.

As line manager the role is critical to develop key talents in the organization to ensure a pool of success in critical roles.

The role should ensure excellent study performance with strict adherence to local regulations, Monitoring Excellence, Vendor management and can represent the CRD in local management if required. Collaborates externally with Investigators, Functional Resourcing Vendors, regulators and Pharma Industry.

• Responsible for country or cluster monitoring resource management, capacity assessments of CRA workload and overall quality of monitoring deliverables from the area across all projects and across all monitoring resources. Ensure metrics are met at expectations.
• Accountable for resource and talent management of our Company CRAs and CRA managers in territory. Manages performance of CRA managers, conducts performance evaluations, encourages high performance to agreed aims and objectives. Addresses low-performance situations and ensures development needs are addressed. Ensures CRA managers do the same with our Company CRAs. Supports recruiting efforts (interviews, hiring).
• Collaborates internally with Country TA Directors, CRD, CRA managers, Monitoring Excellence, Vendor management, Vendor Strategy and Management to develop and build the territory of principal investigators and sites.
• Collaborates externally with Investigators, Functional Resourcing Vendors, regulators and Pharma Industry.
• Oversight and management of local vendors and partners to ensure consistency across country monitoring organization. Will work closely with PLMs and CRA managers to ensure consistency across all monitoring resources. Also, accountable for quality and compliance in monitoring function and the development and execution of Strategic Quality Initiatives within the monitoring function.
• In conjunction with Monitoring Excellence develops monitoring resourcing strategies in the country/cluster with vendors and CRDs to meet current and future resource demands.
• Works with vendors, positions and places CRAs for greatest efficacy & effectiveness.
• Accountable for the overall oversight of all FSP CRAs.
• Collaborates and works closely with the other GCTO management roles, the GCTO Headquarter teams, quality compliance, finance, IT and HR.
• A member of the local Leadership Team for GCTO.
• Works closely with the Country/cluster Leadership team, sponsor and supports strategic initiatives across Global Clinical Development and Global Clinical Trial Operations.
• This position and direct reports have a significant impact on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining regulatory requirements and compliance.
• The position will directly impact the country’s ability to reach business targets and objectives and build productive collaboration with internal and external business partners.

• Business and financial acumen.
• Strategic thinking.
• Ability to think cross-functionally and working across boundaries internationally.
• Ability to identify problems, conflicts and opportunities early and lead, analyze mitigation plans and drive conflict resolution is critical.
• Fluent in Local Language and business proficient in English (verbal and written) and excellent communication skills.
• Excellent ICH-GCP knowledge and knowledge of Good Documentation Practices.
• Very good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Metrics development and management.

• High emotional intelligence.
• Strong leadership and negotiation skills.
• Positive proven success in people management.
• Ability to identify problems, conflicts and opportunities early and lead, analyze and prepare mitigation plans and drive conflict…