Contract - Clinical Data Management Lead
Kriya Therapeutics•Remote, NC
•Remote
About The Position
The Clinical Data Management Lead (Contract) is responsible for operational execution of clinical data management activities across Kriya Therapeutics' clinical development programs. The role combines hands-on data management expertise with cross-functional coordination to ensure data quality, integrity, and regulatory compliance throughout the product development lifecycle. The position partners with internal teams, CROs, and external vendors to support high-quality study execution in a fast-paced biotech environment.
Requirements
- Bachelor's degree in life sciences, health informatics, computer science, or a related field.
- At least 8 years of clinical data management experience in the pharmaceutical or biotechnology industry.
- Strong expertise managing data for Phase I–III clinical trials.
- Solid knowledge of GCP, 21 CFR Part 11, and global regulatory requirements.
- Experience working with or overseeing CROs performing data management activities.
- Ability to work effectively in a collaborative and evolving biotech environment.
- 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, attention to detail, and strong organizational skills.
- Excellent written and verbal communication skills and ability to build collaborative relationships across functions and with external partners.
- Self-motivated, adaptable, and willing to contribute hands-on in a growing, fast-paced organization.
Nice To Haves
- Advanced degree, or equivalent professional experience.
- Experience across multiple therapeutic areas.
- Experience supporting regulatory filings such as IND, CTA, NDA, or BLA.
- Experience with global clinical trials.
Responsibilities
- Execute day-to-day clinical data management activities for assigned studies, including database design, edit-check development, data review, and database lock.
- Contribute to developing and maintaining study-specific data management plans, CRF completion guidelines, data validation specifications, and data transfer agreements.
- Lead and manage CRO data management activities, ensuring deliverables meet quality standards, timelines, and contractual obligations; identify risks and drive resolution.
- Serve as the data management contact for cross-functional study teams, coordinating with clinical operations, biostatistics, medical monitoring, regulatory affairs, CROs, and external vendors.
- Ensure clinical data management activities comply with FDA, ICH-GCP, and other applicable regulatory requirements.
- Develop CRF designs, database structures, edit checks, and coding dictionaries, including MedDRA and WHODrug, in collaboration with CRO partners.
- Conduct data reconciliation, including SAE reconciliation, central lab data integration, and third-party vendor data transfers.
- Support regulatory submission preparation by ensuring data packages meet quality standards and timelines, including CDASH and SDTM compliance.
- Contribute to developing and maintaining SOPs, work instructions, and clinical data management best practices.
- Support clinical data management audit and inspection readiness, including TMF documentation.
- Identify process improvement opportunities and recommend practical ways to improve data management efficiency, quality, and study execution.
- Independently manage assigned study activities, proactively escalate risks, maintain organizational awareness, and support timely decision-making and issue resolution.
- Provide data management input into study protocols, statistical analysis plans, and clinical study reports.
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What This Job Offers
Career Level
Senior
