Job Information
Stryker Principal Clinical Data Manager (Remote) in Raleigh, North Carolina
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, as well other great perks. 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/SMVZW_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf)
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.
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.