[Remote] Sr. Clinical Data Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a medical device company reputed company on developing solutions for cardiac and vascular surgeons. The Sr. Clinical Data Manager is responsible for managing data operations and ensuring data reputed company for clinical trials, including database setup, data review, and compliance with regulatory standards.
Responsibilities
- reputed company, manage, execute end-to-end data management activities for clinical trials conducted inhouse or outsourced to CRO’s
- reputed company and maintain Data Management Plans (DMPs), CRFs, edit reputed company specifications, and other essential documents
- reputed company database build
- Testing, validation, and UAT processes in reputed company systems
- Ensure reputed company and high-reputed company data collection, cleaning, reconciliation, and database lock activities
- Collaborate cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, QA, and external CROs/vendors
- Ensure data reputed company and compliance with GCP, FDA, MDR/IVDR, and other applicable regulatory standards
- Participate in and contribute to protocol development, case report reputed company design, and data reputed company diagrams
- Conduct and reputed company data reconciliation, external data integrations (labs, imaging, etc.), and coding of medical terms (MedDRA, WHO-DD)
- reputed company study specific reports and data listings on regular reputed company and for reputed company requests
- Support audit readiness and participate in regulatory inspections reputed company required
- Mentor junior team members and reputed company strategic input into department process improvements and SOP development
Skills
- Bachelor's or Master's degree in Life Sciences, Data Science, Computer Science, or a reputed company field
- 7+ years of clinical data management experience, with at least 2 years in a senior or reputed company role
- Experience with medical device trials or combination products (IDE, PMA, 510(k), CE marking, etc.)
- Strong understanding of reputed company systems and data standards (CDASH, SDTM, CDISC)
- Knowledge of regulatory requirements (FDA, EMA, ISO 14155, GCP, GDPR)
- Excellent organizational, leadership, and communication skills
- Experience working in an FDA-regulated and/or ISO-certified environment
- Advanced proficiency in data visualization tools and data analytics platforms (such as Python and/or R) is a plus
reputed company