Clinical Data Management Lead (Contract)

Kriya Therapeutics•Durham, NC

7d•Onsite

About The Position

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 BioSpace’s “2025 Best Places to Work.”

Requirements

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.
Solid knowledge of GCP, 21 CFR Part 11, and global regulatory requirements.
Experience working with or overseeing CROs performing data management activities is required.
Demonstrated ability to work effectively in a collaborative and evolving biotech environment with strong organizational, communication, and relationship-management skills.
Working knowledge of drug development processes from pre-IND through regulatory filing.
Strong understanding of clinical trial protocols and data flow processes.
Demonstrated problem-solving ability with strong organizational skills and attention to detail.
Excellent written and verbal communication skills with the ability to build collaborative working relationships across functions and external partners are required.
Self-motivated, adaptable, and willing to contribute in a hands-on manner within a growing and fast-paced organization.

Nice To Haves

Advanced degree preferred, or equivalent professional experience.
Strong expertise managing data for Phase I-III clinical trials; experience across multiple therapeutic areas a plus.
Experience supporting regulatory filings (e.g., IND, CTA, NDA, BLA) and global clinical trials desired.

Responsibilities

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.
Identifies process improvement opportunities and contributes 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.