Work Flexibility: Hybrid

We are seeking a Clinical 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 Clinical 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

• Bachelor's 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)

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.