Principal Clinical Data Manager (Remote)
Principal Clinical Data Manager (Remote)
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Job Description
Principal Clinical Data Manager (Remote)
We are seeking aPrincipal Clinical Data Managerto join ourStryker 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.
What you need
Basic Qualifications
- Bachelors 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 Masters degree or 10 years of experience in clinical data management with a Bachelors 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.
Required Experience:
Manager
Employment Type
Full-Time
