Remote Clinical Data Management Lead - Contract

Kriyatx; North Carolina; Remote; USD 120,000 - 170,000; Part time

Job summary

Kriya Therapeutics, Inc. is seeking a Clinical Data Management Lead (Contract) to oversee operational data management across clinical programs. The role emphasizes hands-on data handling, data quality, and regulatory compliance with CROs and vendors in a fast-paced biotech setting.

The ideal candidate will have 8+ years of data management experience in pharma/biotech, expertise with CDISC standards, and strong collaboration skills to support regulatory submissions and study execution.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 8+ years of clinical data management experience in pharma/biotech.
• Advanced degree preferred, or equivalent experience.
• Strong experience with Phase I–III trials; regulatory filings desirable.
• Solid knowledge of GCP, 21 CFR Part 11, and global regulatory requirements.
• Experience overseeing CROs and cross-functional teams.

Responsibilities

• Manage day-to-day clinical data management activities for assigned studies.
• Develop and maintain study data management plans and CRF guidelines; data validation specs.
• Lead CRO data management activities; ensure quality, timelines, and contracts.
• Serve as data management contact for cross-functional study teams; foster collaboration.
• Ensure FDA/ICH-GCP regulatory compliance across data activities.
• Design CRFs, databases, edit checks; collaborate with CRO partners.
• Oversee data reconciliation and data transfers (SAE, central lab, vendors).
• Support regulatory submissions with CDISC (CDASH/SDTM) compliance.
• Contribute to SOPs and best practices for data management.
• Assist audit readiness and TMF documentation.
• Identify process improvements to enhance efficiency and quality.
• Independently manage studies and escalate risks as needed.
• Provide data management input to study protocols and SAPs.

Skills

Bachelor’s degree in life sciences

8+ years of data management experience

GCP & 21 CFR Part 11 knowledge

Regulatory filings experience (IND/CTA

Cross-functional collaboration

CRO management experience

Data management for Phase I-III trials

Education

Bachelor’s degree in life sciences/related field

Advanced degree preferred

Tools

CDISC (CDASH/SDTM)

MedDRA/WHODrug dictionaries

Job description

Kriya Therapeutics, Inc. is seeking a Clinical Data Management Lead (Contract) to oversee operational data management across clinical programs. The role emphasizes hands-on data handling, data quality, and regulatory compliance with CROs and vendors in a fast-paced biotech setting.

The ideal candidate will have 8+ years of data management experience in pharma/biotech, expertise with CDISC standards, and strong collaboration skills to support regulatory submissions and study execution.