<p>Work Flexibility: Remote</p> <p>Principal Clinical Data Manager (Remote)</p> <p>We are seeking a Principal Clinical Data Manager to join our Stryker Endoscopy Division. In this role, you will serve as the clinical data management expert, overseeing projects ranging from small to large and complex in scope, with minimal guidance from leadership. You will be responsible for leading and managing all clinical data management activities in alignment with quality standards, ICH guidelines, GCP, and regulatory requirements. This includes establishing and maintaining clinical trial databases, ensuring all data-related operations comply with applicable regulations, policies, and procedures. A key focus of this role is to uphold the highest standards of data integrity throughout the research process. Additionally, you will drive process improvements and departmental initiatives, while mentoring and training junior team members.</p> <p>Work Flexibility: Remote - can be based remotely anywhere within the United States.</p> <p>What will you do:</p> <ul> <li>Responsible for reviewing data for assigned clinical projects. Identify data trends on a project level. </li><li>Develop and/or maintain data management plans, Case Report Forms, Database Specifications/Edit Check Specifications. </li><li>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. </li><li>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. </li><li>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. </li><li>Train internal and external collaborators in study specific clinical data management processes, the CRF, EDC system, and completion guidelines. </li><li>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. </li><li>Provides innovative solutions to complex data management problems, serves as best practice resource within and outside data management. </li></ul> <p>What you need</p> <p>Basic Qualifications</p> <ul> <li>Bachelor's degree in a technical and/or scientific discipline. </li><li>Industry experience in medical technology or pharmaceuticals. </li><li>8+ years of experience in clinical data management, in medical device/pharma industry is required with a Master's degree or 10+ years of experience in clinical data management with a Bachelor's degree. </li><li>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. </li><li>Ability with programming languages including the creation of data entry, query processes, data clarification form (DCF) generation, and data quality checks. </li><li>Knowledge with imaging systems, electronic data capture (EDC), and database management systems. </li></ul> <p>Preferred Qualifications</p> <ul> <li>Understanding of CDISC requirements. </li><li>Working knowledge of SAS programming, electronic data capture, and XML </li><li>Previous experience with complex, global trials. </li></ul> <p>Travel Percentage: 10%</p> <p>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.</p> <p>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.</p>