Contract - Clinical Data Management Lead

Kriya Therapeutics; North Carolina; Hybrid; USD 110,000 - 135,000; Part time

Job summary

Kriya Therapeutics, Inc. is seeking a Clinical Data Management Lead for a contract role.

The position focuses on operational execution of data management across development programs, collaborating with cross-functional teams, CROs, and vendors to ensure data quality, integrity, and regulatory compliance throughout the lifecycle. The ideal candidate has 8+ years in clinical data management, a strong GCP/21 CFR Part 11 background, and experience supporting regulatory filings.

Qualifications

• Bachelor's degree in life sciences or related field required; advanced degree preferred.
• Minimum 8 years of clinical data management experience in pharma/biotech.
• Experience with Phase I–III trials across multiple therapeutic areas.
• Strong knowledge of GCP and 21 CFR Part 11.
• Experience supporting regulatory filings and global trials.
• Experience overseeing CRO data management activities.
• Excellent written and verbal communication; collaborative cross-functional work.
• Self-motivated, adaptable in a fast-paced biotech environment.

Responsibilities

• Execute day-to-day data management activities for assigned studies.
• Develop study data management plans and CRF guidelines.
• Lead CRO data management activities and manage risks.
• Coordinate with cross-functional teams on data management deliverables.
• Ensure FDA/ICH-GCP regulatory compliance across data management.
• Design CRF structures and coding dictionaries with CRO partners.
• Support data reconciliation and third-party data transfers.
• Assist regulatory submissions with CDISC compliance.
• Contribute to SOPs and training materials.
• Maintain audit readiness and TMF documentation.
• Identify process improvements and implement efficiencies.
• Manage assigned study activities with proactive escalation.
• Provide data management input to study protocols and SAPs.

Skills

Clinical data management

Cross-functional coordination

Regulatory compliance

Vendor management (CROs)

Data quality & integrity

Problem solving

Strong communication

Biotech/pharma knowledge

GCP familiarity

Education

Bachelor's degree in life sciences / informatics / CS

Advanced degree preferred or equivalent experience

Tools

MedDRA

WHODrug

CDISC CDASH/SDTM

Job description

Clinical Data Management Lead (Contract)

Department: Clinical

Employment Type: Contract

Location: Remote

Description

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.”

Role Overview

The Clinical Data Management Lead (Contract) 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.

Key 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.

Experience & Skills and Work Environment

Experience & Skills

• 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.

Work Environment

• Primarily desk-based, generally in an office or home office setting.
• May involve extended periods of sitting and computer use.
• Ability to stand for extended hours.

Life at Kriya

Discover True Collaborative Teamwork
We have an ambitious set of goals, but our confidence – and our inspiration – stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day.

We’re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.