Senior Clinical Study Manager (Hybrid)

Stryker; Mahwah (NJ); On-site; USD 132,100 - 220,100; Full time

Benefits offered by this job

Health benefits

401(k) plan

ESPP

Wellbeing program

Job summary

Stryker is seeking a Senior Clinical Study Manager in the Joint Replacement division. This hybrid role is based in Mahwah, NJ, and leads cross‑functional projects delivering clinical research initiatives with strong governance and compliance focus.

The position emphasizes managing multiple concurrent studies, optimizing clinical technology platforms, and partnering with quality, IT, and vendor teams to drive scalable solutions for operations.

Qualifications

• Bachelor’s degree in science or health care field.
• 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.

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.

Skills

Cross-functional leadership

Clinical operations

Project management

Regulatory compliance knowledge

Education

Bachelor’s degree in science or health care

Tools

Clinical trial management systems

Electronic data capture

Electronic trial master files

Quality management systems

Job description

Stryker is hiring a Senior Clinical Study Manager for our Joint Replacement division. This is a hybrid position based in Mahwah, NJ.

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.

What You Will Do

• 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.

Required Qualifications

• 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

Preferred 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
• US20: $132,100 - $220,100 USD Annual

Health benefits include: 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. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. 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.