Job Information
Stryker Clinical Study Manager (Hybrid) in Mahwah, New Jersey
Why join Stryker?
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Stryker is seeking to hire a Clinical Study Manager to support Joint Replacement Clinical Trials. This role will be based hybrid in Mahwah, New Jersey.
Who we want
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.
Self-directed innovators . People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
What you will do
As the Clinical Study Manager (CSM), you will manage ongoing Investigator-Initiated Studies and/or Stryker Initiated Studies, setting and managing deliverables for contracts to align with research strategy.
Develop and maintain overall dashboard of clinical and non-clinical studies, including major milestones, objectives, and financial aspects.
Work with internal and external resources to facilitate publication of study results in peer-reviewed journals.
Partner with Legal and Finance team to ensure researchers are reimbursed in compliance with their contracts.
Present study results/updates to various internal stakeholders cross functionally, as needed.
Contribute to trial synopsis, protocol, and amendments to ensure operational feasibility; contribute to defining the Case Report Form content; develop study-specific procedures, contribute to the monitoring plan and other operational documents.
Contribute to system testing as required (e.g. UAT for eCRF screens, database structure, data loading). Ensure proper collection and validation of data and documentation in a timely manner.
Communicate to teams regarding monitoring activities, data flow, and data validation / cleaning; perform patient data validation homogeneously and fulfill required quality standard; ensure study documentation is properly maintained and archived in the Trial Master File
Coordinate and support field-monitoring activities; maintain monthly study highlights (including enrollment curves and timelines) in a timely manner.
Work with trial project teams to assess project risks and issues.
Understand project deliverables and achievement of deliverables.
Communicate with team on changes in project, policy, and priorities.
Responsible to work with health registries and large databases
Work in compliance with clinical process, regulations and data management
Ability to work independently on multiple projects with ability to prioritize tasks
Responsible for initiating and managing research contracts for Investigator Initiated Studies
Support the development and execution of strategies to obtain information and support concerning medical devices undergoing clinical investigation, post market surveillance or marketed/product use evaluation
What you need
Bachelor's degree required, preferably in science, business, or health-related field
4+ years related work experience required
Related clinical trial associate, clinical study associate, clinical research associate or clinical research internship experience required
Previous experience in medical device or pharmaceutical industry preferred
About Stryker
Our benefits:
12 paid holidays annually
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.
For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits (https://cdn-static.findly.com/wp-content/uploads/sites/1427/2023/09/20143933/us-stryker-employee-benefits.pdf)
About Stryker
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 stryker.com. (http:)
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our referral page (https://careers.stryker.com/referrals/)
Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.