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 www.supiramedical.com. 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 Medical's 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 trial's 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 Manager's 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: - Bachelor's 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 $150,000 to $180,000 + 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 hr@shifamed.com.
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