Clinical Data Manager

<div>Job Description - Clinical Data Manager<br/><strong> Job Title:</strong> Clinical Data Manager<br/> <br/> <strong> Location:</strong> [City, State] / Remote / Hybrid<br/> <br/><strong>Job Summary</strong><br/> <br/> We are seeking a detail-oriented <strong> Clinical Data Manager</strong> to oversee the collection, validation, management, and integrity of clinical trial data. The ideal candidate will ensure that clinical study data is accurate, complete, and compliant with regulatory requirements while collaborating with cross-functional teams to support successful clinical research.<br/> <br/><strong>Key Responsibilities</strong><br/> <ul> <li>Design, develop, and maintain clinical databases for clinical trials.</li> <li>Create and review Case Report Forms (CRFs) and electronic CRFs (eCRFs).</li> <li>Perform data validation, data cleaning, and discrepancy management.</li> <li>Develop and execute Data Management Plans (DMPs).</li> <li>Coordinate database setup, user acceptance testing (UAT), and database lock activities.</li> <li>Review data queries and work with clinical sites to resolve discrepancies.</li> <li>Ensure compliance with GCP, ICH, FDA, and applicable regulatory guidelines.</li> <li>Collaborate with Clinical Operations, Biostatistics, Medical Writing, and Programming teams.</li> <li>Monitor data quality metrics and generate status reports.</li> <li>Support audit and inspection readiness by maintaining complete documentation.</li> <li>Manage external vendors such as Electronic Data Capture (EDC) providers when required.</li> <li>Participate in study start-up, conduct, and close-out activities.</li> </ul> <br/><strong>Required Qualifications</strong><br/> <ul> <li>Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Computer Science, or a related field.</li> <li>3+ years of experience in clinical data management.</li> <li>Experience with Electronic Data Capture (EDC) systems such as Medidata Rave, Oracle InForm, REDCap, or Veeva.</li> <li>Strong knowledge of CDISC standards (SDTM, CDASH).</li> <li>Understanding of ICH-GCP, FDA, and clinical research regulations.</li> <li>Experience with data validation, query management, and database lock procedures.</li> <li>Excellent analytical, organizational, and problem-solving skills.</li> <li>Strong written and verbal communication skills.</li> </ul> <br/><strong>Preferred Qualifications</strong><br/> <ul> <li>Certification in Clinical Data Management (CCDM) is a plus.</li> <li>Experience working with CROs or pharmaceutical companies.</li> <li>Knowledge of SAS, SQL, or clinical reporting tools.</li> <li>Familiarity with risk-based monitoring and data quality management.</li> <li>Experience supporting global, multi-site clinical trials.</li> </ul> <br/><strong>Technical Skills</strong><br/> <ul> <li>Electronic Data Capture (EDC) Systems</li> <li>Medidata Rave</li> <li>Oracle InForm</li> <li>REDCap</li> <li>Veeva Vault</li> <li>SAS</li> <li>SQL</li> <li>Microsoft Excel</li> <li>Clinical Trial Management Systems (CTMS)</li> </ul> <br/><strong>Soft Skills</strong><br/> <ul> <li>Strong attention to detail</li> <li>Critical thinking</li> <li>Problem-solving</li> <li>Time management</li> <li>Team collaboration</li> <li>Communication skills</li> <li>Documentation skills</li> <li>Organizational abilities</li> </ul> <br/><strong>Preferred Certifications</strong><br/> <ul> <li>Certified Clinical Data Manager (CCDM)</li> <li>Good Clinical Practice (GCP) Certification</li> </ul> <br/><strong>Benefits</strong><br/> <ul> <li>Competitive salary</li> <li>Health, dental, and vision insurance</li> <li>Paid time off</li> <li>Retirement savings plan</li> <li>Professional development opportunities</li> <li>Flexible work arrangements</li> <li>Employee wellness programs</li> </ul> <br/> This job description is optimized for candidates with experience in clinical data management, EDC systems, regulatory compliance, and clinical trial data quality assurance.</div>