Clinical Data Manager

Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.

Our mission is to forge new frontiers in cardiac care by pioneering sciencedriven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, highrisk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the world’s first biomimetic TAVR valve, DurAVR® THV. This cuttingedge valve, incorporating our proprietary ADAPT® anticalcification technology, is designed to mimic the natural function of a healthy heart valve.

We are seeking a Clinical Data Manager with strong database programming skills to play a pivotal role in managing and ensuring the quality, integrity, and compliance of clinical trial data. This position will collaborate with crossfunctional teams including clinical affairs, regulatory affairs, and quality assurance, and with external partners (CRO, core labs) to support the successful execution of clinical studies.

At Anteris® Technologies, youll be part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices. Join us in our mission to revolutionize structural heart solutions.

Key Responsibilities:

Data Management Planning:

• Develop and maintain Data Management Plans (DMP) and related documentation.
• Define data collection processes, database specifications, and quality standards.
• Lead development and review of SOPs, work instructions, and associated documents for clinical data management.

• Database Design and Maintenance:

  • Design and validate clinical trial databases, Case Report Forms (CRFs), and edit checks.
  • Collaborate with study teams to ensure databases meet protocol requirements and regulatory guidelines.
  • Define, perform, andor coordinate user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected.
  • Integrate data from multiple clinical trialsplatforms
  • Lead the development of internal Data Review Plan and coordinates cross functional team data listing review.
  • Perform ad hoc and scheduled data listing review and generatesresolves queries in EDC.
  • Perform external data reconciliation against EDC.
  • Execute andor distribute data management metrics, listings, and reports.
  • Provide oversight of data management CROservice providers including managing and monitoring the progress of data management activities with CROs andor other service providers on assigned studies; build effective relationships with CROservice provider counterparts.
  • Review and provides feedback to the clinical team on other study documents e.g., Clinical Monitoring plans and vendor specifications.
  • Provide training on the EDC system andor CRF completion guidelines and EDC system to internal or external study team members, as needed.
  • Maintain study DM related documentsfiles for inspection readiness.
  • Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.

  • Data Collection and Validation:

    • Oversee data entry, data cleaning, and query resolution processes.
    • Ensure timely and accurate collection of data from clinical trial sites.
    • Implement and monitor data validation rules to maintain high data quality.

    • Compliance and Quality Assurance:

      • Ensure compliance with Good Clinical Data Management Practices (GCDMP), ICHGCP, and applicable regulatory requirements.
      • Conduct data quality checks and participate in audits as required.

      • Collaboration and Communication:

        • Represent data management in study team meetings, facilitate and provide data management updates andor input when appropriate.
        • Act as a liaison between internal teams and external vendors (e.g., CROs, EDC vendors).
        • Provide training and support to study teams on data management processes and tools.

        • Reporting and Documentation:

          • Generate data reports, listings, and summaries for interim and final analyses.
          • Prepare and archive study documentation in accordance with regulatory requirements.

          • Risk Management:

            • Identify and mitigate risks related to data management activities.
            • Proactively resolve issues that could impact study timelines or data quality.

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              NOTE: Preference given to applicants in the Minneapolis, MN, metro area.

              
              

              Required Skills, Knowledge, Experience, Qualifications:

              • Bachelor’s degree in life sciences, computer science, or related field. Master’s degree preferred.
              • 5+ years of experience in clinical data management within the biotechnology, pharmaceutical, or medical device industry.
              • Proficiency in electronic data capture (EDC) systems such as Medidata Rave, Oracle Clinical, or similar platforms
              • Strong knowledge of clinical trial processes, regulatory requirements, and industry standards (e.g., CDISC, SDTM).
              • Excellent organizational, analytical, and problemsolving skills.
              • Ability to manage multiple projects and prioritize tasks effectively.
              • Strong communication and interpersonal skills to work collaboratively in a crossfunctional environment.

              • Preferred Required Skills, Knowledge, Experience, Qualifications:

                • Certification in clinical data management (e.g., CCDM).
                • Medidata Rave certification(s) strongly preferred.
                • Experience with medical device clinical trials.
                • Familiarity with statistical programming languages such as SAS or R.

                • What We Offer:

                  • Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
                  • Collaborative and dynamic work environment with a culture of innovation and excellence.
                  • Competitive compensation package, including salary, performancebased bonuses, and stock options.
                  • Career development opportunities and a chance to be part of a growing company that values its employees.

                  • Health and Wellness:

                    • Medical, Dental, and Vision Offerings
                    • Flexible Spending Account (FSA)
                    • 401k + Company Match
                    • Life, AD&D, Short Term and LongTerm Disability Insurance
                    • Bonus Plan Eligibility
                    • Employee Equity Program
                    • Paid Holidays & Vacation
                    • Employee Assistance Program
                    • Inclusive Team Environment

                    • Note: We may require proof of COVID19 vaccination to comply with health institutions, state, local municipality, andor travel regulations.

                      Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment it is part of our mission to deliver the best structural heart products on a global scale.
                      

                      
                      

                      Compensation$130 $155k + 15%