Opportunity Details

On Assignment Senior Manager, Global Site Management (Hybrid)

Warren, NJ

KPS Life is hiring a Senior Manager, Global Site Management to be fully dedicated to our sponsor client and located on site 3 days per week in either Armonk, NY , Cambridge MA or Warren, NJ.

We are seeking an experienced site management leader with strong expertise in risk-based monitoring (RBQM), CRO and FSP oversight, and the ability to drive monitoring strategy and inspection readiness across a portfolio of studies. The ideal candidate will have a solid track record of managing performance through metrics and KPIs while collaborating effectively with cross-functional teams.

If this opportunity aligns with your experience and you're looking to take on a high-impact role with meaningful influence on study delivery, I'd welcome the chance to connect.

Summary

The Senior Manager, Global Site Management supports the planning, delivery and oversight of the sponsor's clinical trial portfolio of studies. Responsibilities can include the development, execution and oversight of study risk-based monitoring strategies, oversight of Functional Service Provider (FSP) vendor(s) and CRO Monitoring and Site Management deliverables. Activities can include evaluation of CRA role resource needs in countries, support onboarding and training of staff members, managing performance and quality through evaluation of performance metrics and risk indicators which will include direct communication and intervention with study teams, investigator site staff, FSP staff and CRO staff. The role collaborates with Clinical Trial Management study teams to design fit-for-purpose monitoring strategies, including supporting study risk assessment activities aligned with RBQM methodology.

In addition, the role is responsible for developing study-specific critical data TSDV specifications, ensuring critical data SDR approaches, completing monitoring plan reviews, and acting as an RBQM subject matter expert to both internal and external stakeholder groups. The incumbent also plays a key role in process improvement, innovation initiatives and industry collaboration(s).

The Senior Manager, Global Site Management collaborates closely with Clinical Trial Management, Central Monitoring, GD Quality, Vendor Relationship Management, GCP Quality, Strategic Sourcing and Procurement and Business Operations.

Job Duties

• Creates a study specific monitoring strategy which includes, but is not only limited to the identification of critical data and process, consulting on data review methods (including Key Risk Indicators and appropriate detection approaches) and the study specific monitoring visit strategy.
• Provides monitoring functional expertise to support study budget planning and approval as well as subsequent change orders and ongoing study budget assessments.
• Ensures translation of derived monitoring strategy into Clinical Monitoring Plan and shares with CRO partners and/or sponsor clinical study teams.
• Creates tSDV specifications in collaboration with CROs, Clinical Study Teams and Data Management.
• Participates in Clinical Study Team Meetings and Quality Review Meetings providing input to study teams on existing and emergent operational risks.
• Supports all sponsor site management activities to ensure compliance to the protocol, monitoring plan, ICH GCP, sponsor SOPs, and local operational and regulatory requirements (SQV, SIV, IMV and COV).
• Provides oversight of CRO partner site management activities, including CRO CRA engagement activities, review of CRO CRA resource allocation and performance.
• Oversees CRO partner and FSP CRAs to ensure sites meet performance expectations related to study delivery, including subject identification, enrollment, retention, and timely delivery of quality data.
• Supports establishing productive investigator site relationships through attending a number of targeted site co-visits with the study assigned primary CRA (either CRO or sponsor FSP).
• Establishes a productive professional relationship with CRO counterparts as part of functional oversight responsibilities, working to mitigate and resolve site management/monitoring related issues.
• Directs performance management and oversight of FSP and CROs through pro-active monitoring of metrics and KPIs, including oversight of onboarding activities.
• Partners with CROs to align on 'operational health' messaging at various cross functional and governance forums (e.g., Joint Operating Committee, FSP Model Management Team).
• Supports inspection readiness activities and participates in Regulatory GCP inspections and/or audits.
• Acts as a subject matter expert (SME) and sponsor point of contact for monitoring/site management topics.
• Identifies issues and applies knowledge, prior experience and critical thinking to make decisions; escalates site management-related issues as necessary.
• Maintains regular communication with key cross functional counterparts and participates in applicable forums/meetings to optimize performance and delivery at investigator sites (e.g., CTM, GTO, SSU, VRM).
• Participates and may lead process improvement initiatives.

Job Requirements

• Experience of working in a risk-based quality operating model.
• Knowledge of the drug development process and specific knowledge of clinical trial operations, clinical monitoring and site management process, and associated industry regulations.
• Familiarity with medical terms.
• Excellent interpersonal skills and demonstrated collaborative as well as independent working style.
• Ability to build relationships with internal stakeholders.
• Ability to translate a design strategy into an operating framework.
• Critical thinker.
• Proactive and self-motivated.
• Strong organizational skills with effective use of time and prioritization.
• A working knowledge of ICH/GCP.
• Up to 25% travel required.