Stryker Corporation

Work Flexibility: Hybrid

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

Travel Percentage: 10%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.