Clinical Data Manager

Department: Clinical Affairs / Clinical Data Management Experience: 5+ Years Employment Type: Contract Job Summary We are looking for a detail-oriented Clinical Data Manager to support clinical data management activities for medical device clinical investigations and studies. The candidate will assist in collecting, reviewing, validating, cleaning, and maintaining clinical study data to ensure accuracy, completeness, consistency, and compliance with applicable regulatory requirements and study protocols. The role involves working closely with Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Clinical Operations, Biostatistics, Quality Assurance, and Regulatory Affairs teams. Key Responsibilities Support clinical data management activities for medical device clinical trials and investigations. Assist in developing and maintaining electronic Case Report Forms (eCRFs) and data collection tools. Perform clinical data review, validation, discrepancy identification, and data cleaning. Generate, review, and resolve data queries in coordination with clinical study sites and study teams. Ensure clinical data is accurate, complete, consistent, and collected in accordance with study protocols. Support the development and execution of data validation checks and edit checks. Maintain clinical databases and ensure timely data entry, reconciliation, and database updates. Assist with medical coding activities, including adverse events and medical history, where applicable. Support reconciliation of clinical data with safety databases and other study records, as required. Maintain data management plans, data validation specifications, query logs, and other study documentation. Support database lock activities and preparation of clinical study reports. Ensure compliance with applicable regulatory requirements, Good Clinical Practice (GCP), data privacy requirements, and company standard operating procedures (SOPs). Participate in clinical study audits, inspections, and quality improvement activities as required. Collaborate with cross-functional teams to resolve data discrepancies and maintain study timelines. Required Qualifications Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Biomedical Sciences, Nursing, Public Health, or a related field. 0–3 years of experience in clinical data management, clinical research, clinical operations, or a related area. Basic understanding of clinical trials, clinical study protocols, and clinical data collection processes. Familiarity with electronic data capture (EDC) systems and electronic Case Report Forms (eCRFs). Basic knowledge of clinical data review, query management, and data validation. Strong attention to detail and analytical and problem-solving skills. Proficiency in Microsoft Excel and other Microsoft Office applications. Good written and verbal communication skills. Preferred Qualifications Exposure to medical device clinical investigations or clinical trials. Knowledge of Good Clinical Practice (GCP) and applicable medical device regulations. Familiarity with ISO 14155 for clinical investigations of medical devices. Basic knowledge of CDISC standards, including CDASH and SDTM, where applicable. Experience with EDC platforms such as Medidata Rave, Oracle Clinical, or REDCap. Familiarity with clinical terminology and medical coding tools such as MedDRA or WHODrug. Understanding of data privacy, confidentiality, and clinical research documentation requirements. Key Skills Clinical data review and data cleaning Query management and discrepancy resolution Electronic data capture (EDC) systems Clinical trial documentation Data validation and quality checks Regulatory compliance awareness Analytical thinking and the attention to detail Cross-functional collaboration Key Performance Indicators (KPIs) Accuracy and completeness of clinical study data. Timely review and resolution of data queries. Adherence to study timelines and data management milestones. Compliance with study protocols, SOPs, and applicable regulations. Quality and completeness of clinical data management documentation. Timely support for database cleaning and database lock activities. Ideal Candidate Profile The ideal candidate is a detail-oriented life sciences or healthcare graduate who understands clinical research fundamentals and is interested in clinical data management within the medical device industry. Candidates with clinical research internships, academic research exposure, or familiarity with EDC systems are encouraged to apply. Note: Prior medical device experience is preferred but not mandatory for entry-level candidates. “Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.” #J-18808-Ljbffr