Sr. Manager, Clinical Data Strategy & Systems

Shifamed; Los Gatos (CA); On-site; USD 150,000 - 180,000; Full time

Benefits offered by this job

Equity

Benefits

Job summary

Shifamed seeks a Senior Manager, Clinical Data Management to lead the data management strategy for Supira Medical's cardiovascular IDE trial in Los Gatos, CA. Own CRF design and partner with the Data Manager to ensure audit-ready data and robust clinical systems.

You will drive CRF governance, oversee EDC systems, and ensure compliance with 21 CFR Part 11 and ISO 14155. Salary ranges reflect experience, with equity and benefits included.

Qualifications

• Bachelor's degree in life sciences or related field; advanced degree a plus.
• 8+ years of clinical data management in medical devices or biotech, with CRF ownership.
• Hands-on with EDC systems (iMednet, Clario, Judi) and related data systems.
• Experience mentoring Data Manager or team member.
• Familiar with 21 CFR Part 11 and ISO 14155; data integrity principles.

Responsibilities

• Own data management strategy for the trial, translating protocol into CRF design.
• Lead CRF development and governance with cross-functional teams; manage version control.
• Direct day-to-day build and maintenance of EDC and related systems; ensure alignment with protocol.
• Author and maintain the Data Management Plan and data validation plans.
• Oversee data quality, query management, and SAE/CEC reconciliation.
• Coordinate DSMB/CEC data support and regulatory submission documentation.

Skills

CRF design

Data management strategy

Regulatory compliance

Education

Bachelor's degree in life sciences or related field

CCDM certification or equivalent

Tools

iMednet

Clario

Judi

Job description

Shifamed seeks a Senior Manager, Clinical Data Management to lead the data management strategy for Supira Medical's cardiovascular IDE trial in Los Gatos, CA. Own CRF design and partner with the Data Manager to ensure audit-ready data and robust clinical systems.

You will drive CRF governance, oversee EDC systems, and ensure compliance with 21 CFR Part 11 and ISO 14155. Salary ranges reflect experience, with equity and benefits included.