Execute and own external (non-EDC) data management activities for assigned clinical studies
Develop and maintain Data Transfer Agreements (DTAs) and external data specifications for each external data source
Coordinate and perform test data transfers, including hands-on QC and approval prior to production data flow
Establish and manage external data transfer schedules and reconciliation cycles aligned with study milestones
Import, validate, and reconcile external datasets to ensure completeness, accuracy, and consistency
Perform ongoing external data cleaning and reconciliation, including discrepancy identification, issue investigation, and resolution with vendors
Utilize tools such as SAS (or similar) and data visualization systems to support data review, validation, and reconciliation activities
Serve as the primary external data contact for vendors and CRO partners
Work directly with vendor data management teams to troubleshoot issues and ensure timely, high-quality data delivery
Monitor vendor performance related to data quality and timelines and escalate issues as needed
Act as the external data management lead on study teams
Collaborate closely with Clinical Operations, Biostatistics, Statistical Programming, Safety, and Regulatory teams to ensure data readiness for analyses, reviews, and submissions
Maintain complete and inspection-ready documentation, including DTAs, data transfer logs, reconciliation records, and external data management plans
Ensure all external data activities comply with ICH-GCP, 21 CFR Part 11, CDISC standards, and internal SOPs

Requirements

MS/BS degree in life sciences, health informatics, computer science, or a related field
8+ years of progressive clinical data management experience, including deep, hands-on specialization in external (non-EDC) data management and direct vendor/CRO execution
Alternatively, 12 years of progressive clinical data management experience is required if individual possessed a Bachelor’s degree only
Demonstrated experience independently managing complex external data across the full clinical data lifecycle (study startup through database lock, regulatory submission support, and archiving)
Proven expertise serving as the external data subject matter expert on studies with multiple vendors and data streams
Strong working knowledge of EDC systems, external data transfers, CDISC standards (CDASH/SDTM), and clinical data regulations
Proficiency with hands-on SAS experience (or equivalent) for data validation, reconciliation, and issue investigation
Solid understanding of ICH-GCP, 21 CFR Part 11, and regulatory inspection expectations for external vendor data
Demonstrated ability to work independently with minimal oversight while managing multiple priorities, timelines, and stakeholders

Benefits

Health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
20 days of PTO
10 paid holidays
Winter company shutdown

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

data managementdata validationdata reconciliationdata cleaningexternal data managementclinical data lifecycleSASEDC systemsCDISC standardsregulatory submission support

Soft Skills

independent managementproblem-solvingcollaborationcommunicationvendor managementissue investigationprioritizationattention to detailstakeholder managementtimeliness