Senior Manager, Clinical Data Management

Senior Manager, Clinical Data Management

Department: Clinical

Employment Type: Full Time

Location: Research Triangle Park, NC

Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.

We leverage our proprietary computational engine, in‑house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.

We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of Bio Space’s “2025 Best Places to Work.”

The Senior Manager, Clinical Data Management will be responsible for the operational execution of clinical data management activities across Kriya Therapeutics' clinical development programs. This role combines hands‑on data management expertise with cross‑functional coordination, ensuring data quality, integrity, and regulatory compliance throughout the product development lifecycle. The ideal candidate is a proactive and collaborative data management professional who thrives in a fast‑paced biotech environment, demonstrates strong operational ownership, and effectively partners across internal teams, CROs, and external vendors to drive high‑quality study execution.

• Execute day‑to‑day clinical data management activities for assigned clinical studies, including database design, edit check development, data review, and database lock.
• Contributes to the development and maintenance of study‑specific data management plans, CRF completion guidelines, data validation specifications, and data transfer agreements.
• Leads and proactively manages CRO data management activities, ensuring deliverables meet quality standards, timelines, and contractual obligations while identifying risks and driving resolution.
• Serves as the data management contact for cross‑functional study teams, fostering strong collaboration and proactive communication between clinical operations, biostatistics, medical monitoring, regulatory affairs, CROs, and external vendors.
• Ensure compliance with FDA, ICH‑GCP, and other applicable regulatory requirements across all data management activities.
• Develop CRF designs, database structures, edit checks, and coding dictionaries (MedDRA, WHODrug) in collaboration with CRO partners.
• Conduct data reconciliation activities including SAE reconciliation, central lab data integration, and third‑party vendor data transfers.
• Support preparation for regulatory submissions by ensuring data packages meet quality standards and timelines, including CDISC (CDASH, SDTM) compliance.
• Contribute to the development and maintenance of SOPs, work instructions, and best practices for clinical data management.
• Support audit and inspection readiness activities related to clinical data management, including TMF documentation.
• Identify process improvement opportunities and contribute practical, solutions‑oriented recommendations that enhance data management efficiency, quality, and study execution.
• Independently manages assigned study activities while proactively escalating risks, maintaining organizational awareness, and supporting timely decision‑making and issue resolution.
• Provide data management input into study protocols, statistical analysis plans, and clinical study reports.

• Bachelor’s degree in life sciences, health informatics, computer science, or a related field.
• Minimum 8 years of clinical data management experience in the pharmaceutical/biotech industry.
• Advanced degree preferred, or equivalent professional experience.
• Strong expertise managing data for Phase I‑III clinical trials; experience across multiple therapeutic areas a plus.
• Solid knowledge of GCP, 21 CFR Part 11, and global regulatory requirements.
• Experience supporting regulatory filings (e.g., IND, CTA, NDA, BLA) and global clinical trials desired.
• Experi…