Principal Clinical Data Manager (Remote)

Work Flexibility: Remote

We are seeking a Principal Clinical Data Manager to join our Stryker Endoscopy Division, to be based remotely anywhere within the United States.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. Our Endoscopy Division delivers a diverse array of innovative medical technologies to support minimal invasive surgery through brilliant visualization, connected OR solutions, sports medicine products to sustainability solutions.

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.

 • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. 

• 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 Principal Clinical Data Manager, you will be the clinical data management expert within Endoscopy managing small to large/complex scope projects with minimal guidance from leadership. This position is responsible for guiding and managing all clinical data management activities according to quality standards, ICH guidelines, GCP and regulatory requirements. This person leads the process improvements and initiatives within the department and mentors and trains junior staff members. The role will lead the establishment and management of databases for clinical trials. 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.

• Responsible for reviewing data for assigned clinical projects. Identify data trends on a project level.

• Develop and/or maintain data management plans, Case Report Forms, Database Specifications/Edit Check Specifications.

• Develop complex status reports, specifications for analysis of clinical trial data for interim and final reports, training materials, and other study plans/guidelines. Determine corrective or follow-up action plans as necessary.

• Begin to identify appropriate standard query/Data Clarification Form (DCF) text. Integrate or close queries/DCFs for all categories on a project or program. Perform quality control of queries/DCFs for rest of team.

• Build, test, and validate the programming of electronic data capture (EDC) systems, including design and oversee UAT for studies. Ensure databases are in accordance with internal and external established clinical trial and regulatory standards, and local procedures. 

• Train internal and external collaborators in study specific clinical data management processes, the CRF, EDC system, and completion guidelines.

• Management, tracking and resolution of issues noted by system users, including those requiring submission to system vendors and report development. Troubleshoot data flow and data processing issues.

• Assist in the development, reporting, and continuous improvement of metrics for data management.

• Works independently with guidance required only for the most complex situations.

• Provides innovative solutions to complex data management problems, serves as best practice resource within and outside data management.

• Operates with little/no supervision in a complex environment.

• Decisions are guided by functional strategies and priorities. Leads project teams to achieve milestones and objectives.

What you need

• A minimum of a bachelor’s degree in a technical and/or scientific discipline required.

• M.S in health/science-related field is highly preferred.

• Industry experience in medical technology or pharma is required.

• 8+ year of experience in clinical data management, in medical device/pharma industry is required with a M.S. or 10+ years of experience in clinical data management with a B.S degree.

• Demonstrated ability to lead complex clinical data infrastructure development initiatives from concept through release.                                                                 

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

• Knowledge with imaging systems, electronic data capture (EDC), and database management systems.

• Ability with programming languages including the creation of data entry, query processes, data clarification form (DCF) generation, and data quality checks.

• Knowledge of study development processes, current industry standards, such as, but not limited to: ICH GCP, ISO14155, Good Data Management Practices, IDE requirements, HIPAA, GDPR guidelines, and 21 CFR Part 11 guidelines. 

• Working knowledge of SAS programming, electronic data capture, and XML

• Previous experience with complex, global trials is preferred.

• Understanding of CDISC requirements, required.

• Exercise independent judgment with strong attention to detail.

• Analyze, understand and communicate complicated issues to Managers and Employees to ensure understanding.

• Develop solutions based on best practices and customer feedback.

• Solicit input from managers and exercise independent judgment in providing recommendations to the business.

• Effectively facilitate discussions with and deliver communications to large groups of people.

• Ability to handle multiple concurrent tasks and changing priorities

$112,800 - $239,900 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

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.

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