Sr. Clinical Data Manager

The Clinical Data Manager (or Senior Clinical Data Manager, based on experience) will lead database development and management efforts — encompassing EDC, eTMF, and CTMS systems — in close collaboration with internal stakeholders across Clinical Affairs, Regulatory Affairs, and Biostatistics. This role requires deep expertise in clinical data management and system build, as well as proficiency in data visualization. The ideal candidate will have demonstrated hands‑on experience designing, building, implementing, and maintaining clinical data systems from the ground up, ensuring high‑quality data outputs that support regulatory submissions and cross‑functional decision‑making.

This individual will serve as the functional owner of all clinical data systems and infrastructure and will be expected to assess, revise, and strengthen existing SOPs and data management processes to meet regulatory and operational standards.

As a newly launched commercial company, we require someone who thrives in a fast‑paced, ever‑evolving environment and is excited to both enhance existing systems and build new ones from the ground up. The ability to design scalable data solutions, integrate data from multiple platforms, and adapt to evolving business needs is essential. Experience with cardiac rhythm management (CRM) systems or comparable Class III cardiovascular medical device clinical trials is required.

Familiarity with Real‑World Data (RWD) sources such as claims databases, electronic health records (EHRs), and registries is also valued.

• Develop, implement, and maintain EDC systems for clinical trials.
• Design and validate CRFs (case report forms), ensuring compliance with industry standards.
• Oversee and perform database setup, validation, and user acceptance testing.
• Implement risk‑based monitoring (RBM methodologies to enhance data oversight.
• Lead development, implementation, and ongoing management of eTMF and CTMS systems in collaboration with Clinical Affairs, Regulatory Affairs, and IT stakeholders.
• Ensure cross‑functional data reconciliation and consistency across EDC, eTMF, and CTMS platforms; identify and resolve discrepancies in collaboration with Clinical Operations and Regulatory Affairs.

• Monitor data collection, enforce quality controls, and develop data management plans.
• Author and own Data Management Plans (DMPs), Data Validation Plans (DVPs), and edit check specifications from study startup through database lock; review and revise existing SOPs to ensure alignment with regulatory requirements and current best practices.
• Ensure data compliance with CDISC, SDTM, and CDASH standards for regulatory submissions.
• Collaborate with clinical operations, biostatistics, and regulatory teams to maintain data integrity.
• Establish expectations, tools, and processes that enable effective execution of query management, data cleaning, non‑CRF data review, and issue escalation.
• Review escalations, synthesize insights from the team, and guide prioritization of actions to maintain study readiness for key milestones such as snapshots, database locks, and inspections.

• Partner with biostatisticians on statistical analysis and clinical study report development.
• Provide insights from clinical data to drive study outcomes and business decisions. Proactively monitors data quality trends, performance metrics, and risk indicators, and appropriate corrective and preventive actions are identified and implemented in collaboration with study teams.
• Develop interactive dashboards and visualizations using Power BI or similar tools.
• Deliver ad‑hoc data analyses for regulatory submissions, publications, and internal use.
• Deliver clinical data on a regular schedule to support ongoing business and regulatory needs.

• Ensure compliance with FDA, EMA, GCP, PMDA, and ISO 14155 data regulations applicable to medical device clinical investigations.
• Support audits and regulatory inspections related to clinical data integrity.
• Contribute to regulatory submissions by ensuring high‑quality data…