Clinical Data Manager/Sr. Clinical Data Manager (Onsite/Remote)

The Clinical Data Manager/Sr. Clinical Data Manager will support our clinical trials by designing, building, implementing and maintaining electronic data capture (EDC) systems. This role requires expertise in clinical data management and visualization and proficiency in biostatistics. The ideal candidate will be skilled in data visualization software and capable of managing data collection processes to ensure high-quality clinical data while contributing to regulatory submissions and cross-functional decision-making.

As a pre-commercial company, we require someone who thrives in a dynamic environment, where they will be responsible for building systems from the ground up rather than refining existing ones. The ability to design scalable data solutions, integrate data from multiple platforms, and adapt to evolving business needs is essential. Experience with customer relationship management (CRM) systems is valuable, as is familiarity with Real-World Data (RWD) sources such as claims databases, electronic health records (EHRs), and registries.

Location: Onsite-Sunnyvale, California or Remote

Essential duties and responsibilities include, but are not limited to, the following: 

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.

Data Integrity & Quality Assurance:

• Monitor data collection, enforce quality controls, and develop data management plans.
• Ensure data compliance with CDISC, SDTM, and CDASH standards for regulatory submissions.
• Collaborate with clinical operations, biostatistics, and regulatory teams to maintain data integrity.

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.

Data Reporting & Visualization:

• Develop interactive dashboards and visualizations using Power BI or similar tools.
• Deliver ad-hoc data analyses for regulatory submissions, publications, and internal use.

Regulatory & Compliance Support:

• Ensure compliance with FDA, EMA, GCP, and PMDA data regulations.
• Support audits and regulatory inspections related to clinical data integrity.
• Contribute to regulatory submissions by ensuring high-quality data outputs.

Vendor & Contract Research Organization (CRO) Management:

• 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.

Qualifications:

Education & 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.
• Hands-on experience with EDC systems (Medidata Rave, Veeva Vault, REDCap, or similar).
• Experience with CRM systems and RWD sources is highly desirable.
• Medical device experience is preferred.

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.
• 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.
• Strong analytical and problem-solving skills.
• Ability to work independently in an evolving environment.
• Excellent communication skills to facilitate cross-functional collaboration.
• Detail-oriented with a focus on data accuracy and compliance.
• Proven ability to build scalable processes and systems from scratch in a pre-commercial setting.
• 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 5% of the time to the EBR main office (up to three days per quarter). 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. 

Salary Range:  $117,700 - 180,000*

*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.  

EBR Systems, Inc. is an Equal Opportunity Employer committed to a diverse, inclusive, and equitable workplace. 

EBR Systems, Inc. does not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. Please refrain from solicitations at this time.

Company Overview

Silicon Valley-based EBR Systems is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. The company’s patented proprietary Wireless Stimulation Endocardially (WiSE) technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications and reliability issues in cardiac rhythm disease management.

We are a team of dedicated individuals, driven to deliver superior treatment of millions of patients suffering from cardiac rhythm diseases by developing safe, clinically superior, cost-effective, and reliable therapies using wireless cardiac stimulation. As a fast-paced company, every team member at EBR makes a big contribution towards our mission. We seek candidates who are passionate about improving #healthcare and motivated to do the hard and exciting work required to bring ground-breaking technology to market.

EBR Systems, Inc. offers a great place to work as well as generous benefits and growth opportunities:

• 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 
• Weekly company lunches and occasional happy hour events
• Meaningful work and much more! 

 Please visit us at https://www.ebrsystemsinc.com/ to learn more about our company.