Clinical Project Manager, Real World Evidence, (Remote) - New Jersey, Virtual Address

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company 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 130 million patients annually. More information is available at www.stryker.com 

We are currently seeking a Clinal Project Manager, Real-World Evidence, to join our Spine Division. This is a fully remote Individual Contributor position located in the United States. Preference will be given to candidates located in the Midwest or Eastern US. 

Who we want  

• Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.   

• Strategic thinkers. People who enjoy analyzing data or trends for the- purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.   

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.  

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.   

• Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.   

What you will do  

This position manages the design and execution of regulatory-grade RWE studies to support clinical evidence needs. Working with key stakeholders, the role will execute on key RWE deliverables, establish standards, and best practices for RWE study design and reporting, and support the integration of real-world data sources as an essential part of the clinical evidence generation strategy for Stryker’s product portfolio. This role involves managing cross-functional teams, collaborating with internal and external stakeholders, and ensuring the successful implementation of RWE projects. Strong project management skills, a deep understanding of real-world data methodologies, and knowledge of regulatory requirements are essential for effectively leading RWE initiatives in the company. 

• Develop clinical strategy and data collection strategy to support new product launches and product portfolio.   

• Lead design and execution of RWE studies in close collaboration with internal stakeholders. 

• Author and/or oversee development of study protocols, reports, and peer- reviewed publications using RWD and collaborate cross-functionally to integrate RWD into global publication strategies. 

• Ensure scientific rigor and serve as a methodology expert for real-world evidence generation; select and implement appropriate analytic methods aligned to research needs. 

• Collaborate closely with data management and biostatistics functions to ensure data quality and deliver robust data analyses utilizing scientifically valid and accepted methodology for RWD. 

• Conduct feasibility assessment of relevant data sources for specific devices and indications to ensure data is fit-for-purpose. 

• Collaborate with academic institutions, health systems, registries and/or other health data partners to identify additional real-world data sources for medical device evidence generation. 

• Ensure quality and performance standards for RWE projects are realistic and attained, and studies are conducted in line with quality/compliance framework. 

• Identifies areas of improvement with RWE processes and procedures, develops and implements best practices, and works to improve efficiencies and effectiveness. 

• Participate in cross-functional and cross-divisional initiatives regarding RWE. 

• Manage additional projects, as determined by management (such as NPDP participation, IIS management, etc…).  

• Presents results/updates to internal stakeholders, as needed. 

• Lead cross-functional initiatives and participate in departmental process improvement initiatives. 

What you need 

• A minimum of a bachelor’s degree in a technical and/or scientific discipline required.  

• A minimum of 6 years of experience in clinical trials required. 

• Advanced degree (MSc, MPH, PhD) in epidemiology, health services research, health outcomes research, biostatistics, data science, or related field is highly preferred. 

• 4+ years relevant experience in epidemiology and/or observational research in academia, a contract research organization, and/or the medical device or pharmaceutical industry. 

• Hands-on experience with real-world data (RWD) sets such as national registries, hospital registries, electronic medical records, hospital billing data, and insurance claims databases. 

• Clinical study methodological experience required.  

• Working knowledge of GCP, ICH guidelines, ISO14155, and FDA regulations required. 

• Experience in protocol/report development and familiarity with various tools for data collection required. 

• Effective process and project management skills. 

• Experience developing evidence leveraging real-world data. 

• Proficiency in resource planning and financial management (clinical trial budgeting). 

• Demonstrated problem solving abilities in overseeing clinical evidence generation and clinical strategy development Advanced degree (MSc, MPH, PhD) in epidemiology, health services research, health outcomes research, biostatistics, data science, or related field.