Remote Clinical Data Management Lead (Contract)

Kriya Therapeutics, Inc.; 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

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.