Clinical Data Manager (Hybrid)

We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZWUSStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf)

We are seeking a Cli nical Data Manager to join our Stryker Joint Replacement Division, to be based hybrid two days per week in Mahwah, NJ.

Who we want

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

• Data managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.

• Self-directed initiators . People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

What you will do

As the Clini cal Data Manager, you will participate in continuous breakthrough improvement activity and process re-engineering projects in support of Stryker Orthopedics Business Process Excellence initiatives. This involves ensuring that all data-related operational aspects of studies comply with regulatory guidelines, policies, and procedures, with a primary focus on maintaining the highest possible level of research study data integrity.

Manage clinical data systems and provide support to clinical studies through detailed data review. Ensure compliance with federal regulations, Good Clinical Practices and department SOPs.

Coordinate Case Report Form (CRF) development, review and approve final CRFs

Review and approve data entry screen shots during database development processes

Develop data entry metrics and work closely with the Clinical Study Manager (CSM) to allocate resources based on priorities

Create edit checks for each clinical study database

Coordinate the data entry process

Oversee data entry quality control, create worksheets, review findings, calculate error rates and approve quality control report

Coordinate all cycles of data management during data review and generate data discrepancy criteria

Review listings for quality, content, format and output

Participate in X-ray review and ensure quality of process

Oversee and conduct X-ray quality control on a quarterly basis

Work in collaboration with CSM/Clinical Study Associate to assure timely study development and clinical data reports

Supervise the locking process of study database and sign off approval

Review SAS program specifications and perform UAT when appropriate

Design and/or participate in design of data management documentation and SOPs

Participate in preparation and presentation of data management activities and new initiatives

What you need

Bachelors Degree required; preferably in a technical and/or scientific discipline

Masters Degree in health/science-related field highly preferred

Industry experience in medical technology or pharmaceutical required

6 years of experience in clinical data management, preferably device or pharmaceutical clinical trials

Proficiency in EDC systems, (e.g., Medidata Rave, Oracle)

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.

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.