Clinical Data Manager

OM1 is on a mission to improve health outcomes by unlocking the power of data. We are a healthcare data and technology company focused on real world clinical data and outcomes, accelerating medical research and personalizing healthcare. Our interdisciplinary team uses expertise in medicine, software, Big Data, machine learning, public health and mathematics to transform records from a diverse set of sources into enriched, research grade data which allows us to generate unique insights in a variety of disease areas.
As a Clinical Data Manager, you will play a crucial role in ensuring that Real World Evidence studies collect accurate and complete data that meets regulatory requirements, enabling researchers to develop innovative treatments and therapies that could save lives. You will lead the development and implementation of Electronic Data Capture (EDC) systems, which enable the collection of patient-reported outcomes (ePROs) and case report files (eCRFs). You will also develop quality and reporting processes to monitor data quality and site and study participation, escalating any issues to the project team. Your work will support research and compliance, ensuring that data is accurate, complete, and meets regulatory standards. In this role, you will have the opportunity to make a real impact on the healthcare industry, helping to improve patient outcomes and advance medical research.
The Clinical Data Management team collaborates with cross-functional teams such as Client Services, Clinical Informatics, and Client Engineering. Their main objective is to develop an actionable data management plan that accurately meets the sponsor and study requirements. The team works closely with external sites and sponsors, explaining the available options, trade-offs, and working through study design while ensuring quality and completeness as studies progress. They also partner with the technical teams to ensure that the data being gathered and organized meets the study's needs.

What You'll Do at OM1

• Collaborate with cross-functional teams to review and understand study protocols.
• Collaborate with prospective and current customers to explain OM1 data capabilities and how they can be adapted to the needs of the study.
• Develop and implement Data Management Plans outlining data collection, validation, and cleaning procedures.
• Oversee the design and development of electronic data capture (EDC) systems or databases and ensure they align with study requirements and regulatory standards.
• Supervise and coordinate the collection of clinical trial data from multiple sources.
• Implement procedures for data entry and ensure data is entered accurately and in a timely manner.
• Develop and implement data validation checks to ensure the quality and accuracy of collected data.
• Conduct regular reviews and audits to identify and resolve discrepancies or data issues, collaborating with relevant stakeholders to find solutions.
• Manage the data cleaning process to identify and resolve discrepancies.
• Collaborate with statisticians and other team members to ensure data is locked for statistical analysis.
• Ensure compliance with Good Clinical Data Management Practices (GCDMP) and other relevant guidelines.
• Collaborate with cross-functional teams, including Clinical Operations, Biostatistics, and Regulatory Affairs.
• Provide regular updates on data management activities to internal and external stakeholders
• Provide training to team members on data management procedures and tools.
• Stay informed about new technologies, advancements in clinical data management, and new regulatory requirements.

What Experience You'll Bring

• 5+ years experience acquiring, processing, reviewing, and/or analyzing clinical data.
• Experience developing and managing data in a clinical study environment.
• Deep expertise in electronic data capture (EDC) systems and data management software, such as ePRO and eCRF configuration
• Ability to keep track of numerous, interdependent projects in detail, while providing the context of the bigger picture .
• Experience building data quality plans and operating continuous data quality programs.
• Strong knowledge of regulatory guidelines and standards (e.g., ICH GCP).
• Excellent organizational, communication, and problem-solving skills.
• Strong communication and collaboration with external clients, vendors, sites, and prospects
• Attention to detail and ability to work effectively in a team-oriented environment.

What's Nice to Have

• Degree in a Healthcare related field
• Previous experience in clinical data management, preferably in the pharmaceutical or biotech industry.
• Certified Clinical Data Manager (CCDM) or similar certifications.

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