Senior Clinical Study Manager (Hybrid)

This is a hybrid position based in Mahwah, NJ.

About the role

As Senior Clinical Study Manager, you will serve as the cross-functional project leader responsible for delivering clinical research business initiatives through effective project execution, stakeholder engagement, process improvement, technology implementation, and compliance-focused operational support. This role leads strategic initiatives that improve processes, implement technology solutions, and support operational excellence. Working with cross-functional stakeholders and external partners, you will drive projects that enhance clinical systems, streamline workflows, and strengthen business performance.

Responsibilities

• Lead cross-functional projects from initiation through implementation, stabilization, and closeout, ensuring milestones, budgets, and timelines are achieved.
• Develop and maintain project plans, resource forecasts, communication strategies, and risk mitigation plans to support successful delivery.
• Drive implementation and optimization of clinical research technology platforms, coordinating requirements gathering, testing, deployment, and adoption activities.
• Partner with business, quality, information technology, and vendor teams to design scalable solutions that support clinical research operations.
• Facilitate user acceptance testing, training activities, change management initiatives, and post-implementation support.
• Identify opportunities to improve efficiency, quality, compliance, and user experience through process mapping, workflow redesign, and standardization efforts.
• Establish project governance structures and provide leadership updates, metrics, and reporting on project performance, risks, and adoption outcomes.
• Maintain compliant, inspection-ready documentation and support validation, audit readiness, and regulatory compliance activities throughout the project lifecycle.

Requirements

• Bachelor’s degree in science or health care field
• Minimum 6 years of clinical affairs, clinical operations, and/or clinical project management experience within the device or pharmaceutical industry
• Experience leading cross-functional projects involving business process transformation, systems implementation, or operational improvement initiatives
• Experience managing multiple projects and competing priorities simultaneously

Qualifications

• Experience implementing or optimizing clinical technology platforms such as clinical trial management systems, electronic data capture systems, electronic trial master files, electronic clinical outcome assessment tools, analytics, reporting, or quality management systems
• Knowledge of clinical research regulations and standards, including ISO 14155
• Project Management Professional (PMP), Agile, Six Sigma, or comparable certification

Pay

$132,100 - $220,100 USD Annual

Benefits

• Medical and prescription drug insurance
• Dental insurance
• Vision insurance
• Critical illness insurance
• Accident insurance
• Hospital indemnity insurance
• Personalized healthcare support
• Wellbeing program and tobacco cessation program
• Health Savings Account (HSA)
• Flexible Spending Accounts (FSAs)
• 401(k) plan
• Employee Stock Purchase Plan (ESPP)
• Basic life and AD&D insurance
• Short-term disability insurance

Depending on customer requirements, employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.