Lead Data Manager

Key Responsibilities

• Serve as the Data Management lead for one or more clinical studies, accountable for end-to-end data management activities from study start-up through database lock.
• Develop and maintain study-level Data Management Plans (DMPs), CRF completion guidelines, edit check specifications, and other data management documentation.
• Lead EDC system setup, user acceptance testing (UAT), and database change control in collaboration with vendors and internal teams.
• Cover ongoing data review, query management, and data cleaning activities to ensure data integrity and completeness.
• Oversee external data handling, including laboratory, ECG, imaging, PK/PD, and ePRO integrations, ensuring timely reconciliation and issue resolution.
• Monitor study progress, track data metrics, and proactively identify and address data-related risks and delays.
• Lead database lock planning and execution, including review of data listings and coordination of cross-functional deliverables.
• Serve as the primary point of contact for CROs, EDC vendors, and functional partners for assigned studies.
• Ensure compliance with Madrigal SOPs, GCP, ICH, and regulatory requirements in all data management activities.
• Contribute to process improvement initiatives and provide input on departmental tools, templates, and standards.
• May provide training, mentoring, and oversight to junior data management staff.

Qualifications And Experience

• Bachelor’s degree in Life Sciences, Computer Science, or related field.
• Minimum of 5–7 years of experience in clinical data management within the pharmaceutical or biotechnology industry, including study-level lead experience.
• Demonstrated proficiency with EDC systems such as Medidata Rave, Oracle InForm, or Veeva CDMS.
• Strong understanding of clinical data standards (CDASH, SDTM) and data integration practices.
• Working knowledge of ICH GCP, FDA, and other regulatory guidelines relevant to clinical research.
• Prominent ability to manage vendor deliverables, timelines, and budgets.
• Excellent organizational, analytical, and problem-solving skills.
• Strong written and verbal communication skills with experience presenting data management deliverables cross-functionally.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).