Key Responsibilities
- Assist in the setup, maintenance, and closeout of clinical study databases across multiple phases.
- Support Data Managers to ensure data accuracy, completeness, and consistency.
- Perform routine data entry checks; generate and track data queries; ensure timely resolution with sites and vendors.
- Participate in review/testing of EDC systems, CRFs, and data validation specifications.
- Track receipt/review of external data sources (e.g., labs, imaging, PK/PD, ECG, ePRO) for timely integration/reconciliation.
- Assist in preparation of Data Management Plans (DMPs), edit checks, and data validation listings.
- Maintain documentation of data cleaning activities in accordance with SOPs, GCP, and regulatory requirements.
- Participate in data review meetings and support database lock readiness.
- Support audit/inspection preparation by ensuring documentation accuracy and traceability.
Qualifications & Experience (Required)
- Bachelorβs degree in Life Sciences, Computer Science, or related field.
- 1β2 yearsβ experience in clinical data management or related clinical research role (pharma/biotech).
- Working knowledge of clinical trial processes and regulatory guidelines (GCP, ICH, FDA).
- Experience with one or more EDC systems (Medidata Rave, Oracle InForm, Veeva CDMS).
- Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook).
- Strong attention to detail/organizational skills; excellent written/verbal communication.
- Ability to work in a hybrid environment and manage multiple priorities.
Preferred
- Exposure to complex/adaptive designs; Phase II/III experience.
- Familiarity with external vendor data (central labs, imaging, ECG, ePRO, PK/PD).
- Oncology/metabolic/cardiovascular trial experience.
- Data reconciliation, SAE reconciliation, or data review listings generation.
Benefits (if eligible)
- Comprehensive benefits including flexible paid time off, medical/dental/vision, life/disability insurance, and 401(k).
Application Instructions
- Apply via the Madrigal Careers site on an ongoing basis.