Clinical Study Manager

**Why join Stryker?**

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

**About Stryker**

**Know someone at Stryker?**

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.