[Hiring] Head, Site Management and Monitoring @MSD

Role Description

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.

Responsibilities

• Responsible for country or cluster monitoring resource management, capacity assessments of CRA workload, and overall quality of monitoring deliverables.
• 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.
• Oversight and management of local vendors and partners to ensure consistency across country monitoring organization.
• Works closely with PLMs and CRA managers to ensure consistency across all monitoring resources.
• Accountable for quality and compliance in monitoring function and the development and execution of Strategic Quality Initiatives.
• In conjunction with Monitoring Excellence, develops monitoring resourcing strategies in the country/cluster with vendors and CRDs.
• 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 other GCTO management roles, 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.

Qualifications

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

Requirements

• Minimum of 12 years’ experience within Pharmaceutical Industry.
• Minimum of 10 years’ experience in clinical trial organization.
• Minimum of 5 years’ experience in a functional management position.

Preferred Skills

• CRA experience.
• Management of CRAs and familiarity with outsourcing and flexible resourcing models.

Educational Requirements

• Bachelor's degree in Science or equivalent healthcare experience.
• Advanced degree (e.g., MD, PhD, Pharm D, MS) is advantageous.

Benefits

• Comprehensive package of benefits including medical, dental, vision healthcare, and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.