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Job Summary:
We are seeking a highly experienced Data Management professional to oversee and execute all aspects of clinical data management across our clinical studies. This role will ensure the accuracy, integrity, and timeliness of clinical trial data, liaising with internal teams and external CROs to support clinical development and regulatory submissions. The ideal candidate has extensive experience with eCRF development, database build and validation, data review and reconciliation, and regulatory documentation.

Key Responsibilities:

• Oversee all data management activities conducted by CROs from study start-up through database lock.
• Lead eCRF development and cross-functional reviews of eCRF content.
• Manage database build activities, including review of edit check specifications and performance management of user acceptance testing (UAT).
• Monitor ongoing data collection, ensuring accuracy of individual subject data and datasets generated for interim analyses, publications, CSRs, DSURs, IBs, and other business needs.
• Oversee database lock, archiving of study data, and ensure compliance with regulatory requirements.
• Review and provide input to clinical protocols/amendments, clinical study reports, and statistical analysis plans.
• Manage and review Data Management Plans to ensure consistency across clinical studies.
• Participate in internal reviews of eCRF completion guidelines and other clinical trial documents.
• Support the definition, review, and testing of randomization systems and integration with clinical databases.
• Define specifications for final database structures and manage the transfer of data from multiple vendors.
• Perform reconciliation between eCRF data and external databases, including serious adverse events and translational data.
• Create and deliver in-process data reports to support decision-making in clinical trials, including safety reviews.
• Liaise with safety vendors to ensure appropriate reconciliation of clinical databases.
• Represent Data Management in cross-functional team meetings and vendor interactions, effectively communicating requirements, strategies, metrics, timelines, and deliverables.
• Assist in drafting and reviewing project timelines to ensure deliverables and milestones are met.
• Establish best practices and develop data management SOPs and processes as required.
• Collaborate with cross-functional leaders to prepare clinical study reports and other regulatory documents, including BLA submissions.
• Support GCP inspection readiness in all data management domains.

Qualifications:

• Bachelor's degree in Life Sciences, Computer Science, or related field (advanced degree preferred).
• Extensive experience in clinical data management across Phase I-III trials.
• Expertise in eCRF design, database build, data validation, and reconciliation.
• Strong knowledge of regulatory requirements (GCP, ICH, FDA/EMA guidelines).
• Experience managing CROs and cross-functional teams.
• Excellent communication and leadership skills.
• Strong analytical and problem-solving abilities.

Preferred Skills:

• Experience with CDISC standards (SDTM/ADaM).
• Experience with data visualization and reporting tools.
• Prior involvement in regulatory submissions (CSRs, BLAs).

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