Clinical Data Manager

Anteris Technologies; United States; Remote; USD 137,000 - 216,000; Full time

Job summary

Join a forward-thinking company dedicated to revolutionizing cardiac care as a Clinical Data Manager. In this pivotal remote role, you'll manage and ensure the quality and integrity of clinical trial data, collaborating with cross-functional teams to support groundbreaking medical devices. Your expertise will help enhance the quality of life for patients with aortic stenosis, as you develop data management plans, validate databases, and ensure compliance with industry standards. This is an exciting opportunity to be part of a mission-driven team that values innovation and excellence in healthcare.

Benefits

Medical, Dental, and Vision Offerings

Flexible Spending Account (FSA)

401k + Company Match

Life and Disability Insurance

Employee Stock Option Plan

Paid Holidays & Vacation

Employee Assistance Program

Qualifications

• 5+ years of experience in clinical data management.
• Proficiency in EDC systems and clinical trial processes.
• Strong analytical and problem-solving skills.

Responsibilities

• Develop and maintain Data Management Plans and documentation.
• Design and validate clinical trial databases and Case Report Forms.
• Ensure compliance with Good Clinical Data Management Practices.

Skills

Clinical Data Management

Electronic Data Capture (EDC)

Regulatory Compliance

Data Quality Assurance

Statistical Programming (SAS, R)

Education

Bachelor's degree in life sciences

Master's degree in related field

Tools

Medidata Rave

Oracle Clinical

Job description

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Global Talent Leader @ Anteris. Ally. She/Her. #NKAWTG

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 science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk 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 cutting-edge valve, incorporating our proprietary ADAPT anti-calcification technology, is designed to mimic the natural function of a healthy heart valve.

We are seeking a Clinical Data Manager to play a pivotal role in managing and ensuring the quality, integrity, and compliance of clinical trial data. This remote position will collaborate with cross-functional 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, you'll 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, and/or coordinate user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected.
• Integrate data from multiple clinical trials/platforms
• 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 generates/resolves queries in EDC.
• Perform external data reconciliation against EDC.
• Execute and/or distribute data management metrics, listings, and reports.
• Provide oversight of data management CRO/service providers including managing and monitoring the progress of data management activities with CROs and/or other service providers on assigned studies; build effective relationships with CRO/service 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 and/or CRF completion guidelines and EDC system to internal or external study team members, as needed.
• Maintain study DM related documents/files 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), ICH-GCP, 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 and/or 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.
  
  
  

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 problem-solving skills.
• Ability to manage multiple projects and prioritize tasks effectively.
• Strong communication and interpersonal skills to work collaboratively in a cross-functional environment.
  
  
  

Preferred Qualifications:

• Experience with medical device clinical trials.
• Certification in clinical data management (e.g., CCDM).
• 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, performance-based bonuses, and stock options.
• Career development opportunities and a chance to be part of a growing company that values its employees.
  
  
  

Health and Wellness Offerings:

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

Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Medical Equipment Manufacturing

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