<p>Overview</p> <p>The Clinical Data Manager ensures high-quality, regulatory-compliant clinical data management, which is critical for the integrity and efficiency of clinical trial data and contributes to the overall success of clinical research initiatives. The Clinical Data Manager (CDM) oversees the lifecycle of clinical study data, from collection to database lock and archival, and oversees supporting clinical data systems with a focus on maintaining data quality and compliance.</p> <p>Responsibilities</p> <p>Data Collection Planning and Setup:</p> <ul> <li>Collaborate with clinical stakeholders to design and document data collection requirements. </li><li>Review Case Report Forms (CRFs) to ensure they align with protocol objectives and statistical analysis plans. </li><li>Develop and maintain a Data Management Plan (DMP) detailing all data management activities, workflows, and standards. </li></ul> <p>Data Quality Control:</p> <ul> <li>Assess the overall quality of data, identifying and escalating key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns </li><li>Manage data cleaning processes by setting up and monitoring validation checks to flag unusual or erroneous entries, ensuring timely and accurate completion of queries, escalating issues as needed. </li><li>Conduct data review meetings with cross-functional teams to address major data issues and ensure the database is audit-ready. </li><li>Plan and execute database lock/archival activities by coordinating with the EDC Programmer and other stakeholders to ensure all data is finalized compliant with data retention policies for regulatory inspections. </li><li>Support study-level audit and inspection readiness activities. </li></ul> <p>Cross-functional Collaboration and Documentation:</p> <ul> <li>Participate in SOP development, training, process mapping, and other departmental activities </li><li>Able to cultivate effective and productive working relationships with colleagues, vendors and senior management. Able to use clear judgment to solve problems and to escalate issues with proposed solutions </li><li>Work closely with EDC Programmers to ensure the system supports all protocol and data capture requirements and assess the impact of all mid-study updates to the database. </li><li>Document all data management activities in compliance with SOPs, GCP, and regulatory standards. </li></ul> <p>Qualifications</p> <p>Required:</p> <ul> <li>Bachelor's degree in life sciences, health informatics, data science, or a related field. </li><li>3+ years of experience in clinical data management within medical device, pharmaceutical, or CRO settings or related field. </li><li>Hands-on experience with Electronic Data Capture (EDC) systems (e.g., Zelta, Medidata Rave, Veeva CDMS, or similar). </li><li>Strong knowledge of regulatory requirements, including FDA regulations (21 CFR Part 11), ISO 14155, and ICH GCP. </li><li>Experience developing and implementing Data Management Plans (DMPs), data cleaning strategies, and database specifications. </li><li>Strong analytical skills with attention to detail and data integrity. </li><li>Excellent communication and collaboration skills, with the ability to work cross-functionally with clinical teams, biostatistics, and regulatory affairs. </li></ul> <p>Preferred:</p> <ul> <li>Master's degree in a relevant field. </li><li>Experience with clinical data standards such as CDISC/CDASH and SDTM. </li><li>Has a working knowledge of relational database design </li><li>Knowledge of database programming languages (e.g., SQL) or data visualization tools (e.g., Power BI). </li><li>Experience with risk-based monitoring (RBM) strategies and clinical trial risk assessment methodologies. </li><li>Familiarity with real-world data (RWD) integration and external data sources (e.g., lab data, imaging data). </li><li>Previous experience supporting regulatory inspections. </li></ul>