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Sr. Manager, Clinical Data Management
Job Location:
Job Location:
Los Gatos, CA - USA
Monthly Salary:
$ 150000 - 180000
Monthly Salary:
Posted:
27 August 2026 (17 days ago)
Posted:
Application Deadline:
24 November 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Supira Medical a clinical-stage Shifamed Portfolio Company is developing a low-profile high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffering from cardiogenic shock. To learn more about Supira Medical please visit .
ABOUT SHIFAMED
Founded in 2009 by serial entrepreneur Amr Salahieh Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.
Description:
The Senior Manager Clinical Data Management sets the data management strategy for Supira Medicals cardiovascular IDE clinical trial with particular ownership of case report form (CRF) design and the clinical systems that house patient data. This individual translates the protocol and statistical analysis plan into a data capture strategy that is fit for purpose then partners closely day to day with a Data Manager to build validate and maintain the EDC and related clinical systems (randomization/IWRS imaging safety and patient screening databases) against that strategy. The role ensures data is captured completely accurately and in a state that is audit-ready and submission-ready and works cross-functionally with Biostatistics Clinical Operations Monitoring Medical Safety and Regulatory Affairs to keep the trials data infrastructure aligned to study needs from first-patient-in through database lock.
Responsibilities Skills & Hands-On Experience:
- CRF Design Strategy: Own the data management strategy for the trial translating protocol and SAP requirements into a CRF design that captures the right data at the right timepoints in the right structure to support endpoint analysis and CEC/DSMB review.
- CRF Development & Governance: Lead CRF development and review cycles with Monitoring Clinical Operations and Medical Safety; drive decisions on form structure skip logic edit checks and controlled terminology and manage CRF version control and change history.
- Clinical Systems Oversight: Direct the Data Manager on day-to-day build configuration and maintenance of the EDC and related clinical systems (IWRS/randomization safety database CEC/DSMB data portals) that house patient data ensuring systems reflect the current protocol and CRF design.
- Data Management Planning: Author and maintain the Data Management Plan (DMP) edit check specifications data validation plan and CRF completion guidelines; ensure documentation stays current across protocol amendments.
- Data Quality & Reconciliation: Oversee query management data cleaning cycles and SAE/CEC reconciliation between the clinical database and safety systems; set priorities and quality standards for the Data Managers daily work.
- Regulatory & Data Integrity Compliance: Ensure all data management activities comply with 21 CFR Part 11 ISO 14155 and ALCOA data integrity principles; maintain systems and processes in an audit- and inspection-ready state.
- Vendor Management: Select and manage EDC and coding vendors (e.g. MedDRA/WHODrug); hold vendors accountable for system build timelines validation deliverables and ongoing support quality.
- Timeline & Milestone Management: Own the data management timeline including database build UAT interim analyses and database lock; provide status updates and risk mitigation plans to Clinical Affairs leadership.
- DSMB & CEC Data Support: Coordinate data transfers listings and extracts supporting DSMB reviews and CEC adjudication; partner with Biostatistics on dataset specifications and edit check logic.
- Submission Support: Collaborate with Regulatory Affairs and Biostatistics to prepare annotated CRFs (aCRFs) and data management documentation supporting IDE supplements and PMA submission.
- Team Leadership: Directly manage and mentor the Data Manager; set priorities review deliverables and build data management capacity as the trial scales.
Education & Work Experience:
- Bachelors degree in life sciences health informatics computer science or a related field; advanced degree a plus.
- 8 years of clinical data management experience in the medical device or pharmaceutical/biotech industry including direct ownership of CRF design and development.
- Hands-on experience with EDC systems (e.g. iMednet Clario Judi a plus) and overseeing the clinical systems that house patient data.
- Demonstrated experience managing or mentoring a Data Manager or data management team member.
- Working knowledge of 21 CFR Part 11 and ISO 14155 as they apply to clinical data systems and data integrity.
- Experience developing Data Management Plans edit check specifications and data validation plans.
- Experience with query management SAE reconciliation and coordinating data for DSMB or CEC review.
- Strong project management and vendor management skills with the ability to manage competing priorities across a fast-moving trial.
- Familiarity with CDISC standards (CDASH SDTM) and preparation of annotated CRFs for regulatory submission.
- Excellent written and verbal communication skills with the ability to translate protocol and statistical requirements into practical data capture design.
- Direct experience supporting an IDE pivotal trial for a cardiovascular structural heart or other Class III device from CRF design through database lock preferred.
- Experience with randomization/IWRS systems and integrating multiple clinical systems (EDC safety CEC/DSMB portals) into a single data flow preferred.
- Experience at an early-stage or venture-backed medical device company preferred.
- CCDM certification or equivalent.
Our salary ranges are calculated by role level and location. Please note that your position within that range will be determined by your job-related knowledge location skills experience relevant education and training/certifications. The base salary range for this full-time position is between $150000 to $180000 equity benefits.
NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to
Required Experience:
Manager
