Job Description
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. Work Flexibility: Remote - can be based remotely anywhere within the United States.
What will you do: - 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.
- Provides innovative solutions to complex data management problems, serves as best practice resource within and outside data management.
Basic Qualifications What you need - Bachelor’s degree in a technical and/or scientific discipline.
- Industry experience in medical technology or pharmaceuticals.
- 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.
- 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.
- Ability with programming languages including the creation of data entry, query processes, data clarification form (DCF) generation, and data quality checks.
- Knowledge with imaging systems, electronic data capture (EDC), and database management systems.
Preferred Qualifications - Understanding of CDISC requirements.
- Working knowledge of SAS programming, electronic data capture, and XML
- Previous experience with complex, global trials.
$125,600 - $245,800 salary plus bonus eligible + generally eligible for short-term and long-term financial incentives + benefits. Individual pay is based on skills, experience, and other relevant factors.
This role will be posted for a minimum of 3 days.
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.
Job Tags
Temporary work, Interim role, Local area, Remote work, Flexible hours,