Staff Clinical Data Manager

Work Flexibility: Hybrid<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p><b>What will you do:</b></p><ul><li>Develop and maintain data management documentation, including study protocols, case report forms and data management plans.</li><li><b>Design case report forms (CRFs</b>) and <b>electronic data capture (EDC)</b> systems for data collection.</li><li>Perform data entry and cleaning activities, including discrepancy management and query resolution.</li><li>Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.</li><li>Conduct data review from other modules and vendors utilized for the study.</li><li>Develop and execute standard operating procedures (SOPs) for approval, data entry screen design and testing, validation check testing and approval.</li><li>Collaborate with study team members to resolve data-related issues and discrepancies.</li><li>Generate and review data listings, summaries and reports for clinical study reports.</li><li>Serve as a primary or backup resource for issues about data management.</li><li>Ensure compliance with guidelines, <b>Good Clinical Practice (GCP</b>), <b>CDISC</b> standards and other relevant regulations.</li><li>Contribute to the development and validation of data management software tools.  </li></ul><p></p><p><b>What will you need:</b></p><p><b>Basic qualifications: </b></p><ul><li>Bachelor’s degree in a scientific or healthcare-related field.</li><li>Minimum 5 years of experience in clinical data management or a similar role in the pharmaceutical or clinical research industry. Experience in medical devices company is preferred.</li><li>Strong understanding of clinical trial processes, data management principles and regulatory guidelines.</li><li>Proficiency in electronic data capture (EDC) systems and clinical data management software.</li><li>Familiarity with relevant regulations and guidelines, like GCP and CDISC standards.</li><li>Knowledge of industry-standard data analysis and reporting software, such as SAS, SQL and/or Oracle Clinical.</li><li>Excellent attention to detail with problem-solving and analytical skills.</li><li>Strong organizational and time management abilities.</li></ul><p></p><p><b>Preferred qualifications: </b></p><ul><li>Certification in clinical data management (like CCDM).</li><li>Knowledge of CRF design, MS Project and analytical capabilities.</li><li>Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM).</li><li>Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).</li><li>Understanding of data privacy and protection regulations (e.g., GDPR).</li><li>Effective communication and interpersonal skills to collaborate with other teams.</li></ul><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Travel Percentage: None<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p></p><p></p><p></p><p></p>