Clinical Data Management Lead (Contract)

Kriya Therapeutics•Morrisville, NC

6d•Hybrid

About The Position

The Clinical Data Management Lead (Contractor) 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.

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.
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.
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.

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.