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. ESSENTIAL DUTIES & RESPONSIBILITIES Clinical Database & Data Management 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. Data Integrity & Quality Assurance 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. Analytical & Statistical Expertise 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. Regulatory & Compliance Support 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 outputs. Oversee data‑related interactions with CROs and external vendors. Ensure outsourced activities align with regulatory requirements and internal data standards. Cross‑Functional Collaboration Work closely with clinical, regulatory, and commercial teams to integrate data insights. Provide leadership in designing scalable clinical data management solutions. Train and guide internal teams on best practices in data collection and analysis. SUPERVISORY RESPONSIBILITIES This is an individual contributor (IC) role at this time. As the organization scales, the role may expand to include oversight of CRO data management personnel, junior data managers, or external vendors. Candidates should demonstrate readiness for future team leadership. QUALIFICATIONS Education & Required Experience Bachelor’s degree in life sciences, biostatistics, computer sciences, or a related field is required. Advanced degree in life sciences, biostatistics, computer sciences or a related field is a plus. Minimum of 5+ years (Manager) or 7+ years (Senior Manager) in clinical data management. Experience supporting IDE or PMA submissions, specifically the data management and data package components, is strongly preferred. Hands‑on EDC programming and database build experience; proficiency in Imedidata, Medidata Rave, or Zelta (Navitas) is required. Experience with additional platforms such as Veeva Vault or REDCap is a plus. Experience with cardiac rhythm management (CRM) systems or comparable Class III cardiovascular medical device clinical trials is required. Demonstrated competency in hands‑on EDC system build and configuration, eTMF platform administration, and CTMS management is strongly preferred. Class III medical device experience, specifically in cardiovascular / cardiac rhythm management (CRM) or a comparable Class III CV device program, is required. Knowledge, Skills, and Abilities Strong understanding of clinical trial data flow and regulatory requirements. Demonstrated knowledge and deep understanding of regulations and industry‑adopted data standards such as CDISC, SDTM, and CDASH. Working knowledge of ISO 14155 (GCP for medical device clinical investigations) and its application to clinical data management; ability to distinguish device‑specific regulatory requirements from pharma‑only frameworks. Demonstrated knowledge and deep understanding of regulatory standards, including FDA, EMA, GCP, and PMDA guidelines, and how they apply to clinical data management. Ability to perform data validation, cleaning, and query resolution. Demonstrated ability to author Data Management Plans (DMPs), Data Validation Plans (DVPs), and edit check specifications independently, and to review and revise existing SOPs to close compliance or process gaps. Strong analytical and problem‑solving skills. Comfortable operating in a newly commercial environment where SOPs, processes, and infrastructure may be incomplete or require significant revision; ability to identify gaps, propose solutions, and drive improvements with minimal direction. Excellent communication skills to facilitate cross‑functional collaboration. Detail‑oriented with a focus on data accuracy and compliance. Proven ability to independently lead and build scalable clinical data systems (EDC, eTMF, CTMS) from the ground up in a pre‑commercial or startup medical device environment; must be able to own and drive these efforts with minimal oversight. Hands‑on proficiency with eTMF and CTMS platforms; experience administering, configuring, or leading implementation of these systems is required. Background in field‑based clinical support or close collaboration with investigative sites. Strong understanding of clinical research processes, study design, and data workflows. Proven ability to analyze data trends and translate insights into operational improvements. Strong written and verbal communication skills and ability to work in a fast‑paced cross‑functional environment. Proficiency in MS Word, Excel, PowerPoint, and Teams. Certified Clinical Data Manager (CCDM) preferred. Proficiency in SQL, SAS, or Python is a plus. Familiarity with AI/ML‑driven data insights is a plus. Physical Requirements Willingness and able to travel approximately 15% of the time to the EBR main office or other offsite locations. Travel may include weekends and overnight stay. Required to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms. Required to stoop, kneel, bend, crouch and lift up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, color vision and the ability to adjust focus. Subject to extended periods of sitting and/or standing, vision to monitor, and moderate noise levels. $115,600.00 - $156,400.00* *Base pay is one part of your total compensation. The salary offered will depend on several factors, including, but not limited to your experience, knowledge, skills, location, internal equity, and market alignment. Addition compensation may include bonuses and equity, along with a comprehensive benefits package. Medical, dental, and vision insurance provided at no cost for employee‑only coverage 401(k) matching plan Paid Time Off – starting at 3 weeks per year Competitive salary with opportunities for career growth Employee stock options Life & AD&D and long‑term disability insurance Education assistance Voluntary commuter benefits and pet insurance Meaningful work and much more! Equal Opportunity Employer Veterans/Disabled #J-18808-Ljbffr