External Data Management Specialist

Redbock - an NES Fircroft company; San Francisco (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Redbock - an NES Fircroft company is seeking an experienced External Data Management Specialist to support the collection, oversight, and integration of third-party clinical trial data across study lifecycle. The role serves as a primary contact for external data sources such as laboratories, imaging vendors, ECG providers, and other clinical service partners.

You will ensure data quality, regulatory compliance, and seamless collaboration with biostatistics, programming, and clinical operations.

Qualifications

• Bachelor's degree or equivalent in life sciences or related field.
• Experience supporting external clinical trial data management activities.
• Working knowledge of ICH-GCP and FDA regulations.
• Strong organization and multitasking abilities.
• Excellent written and verbal communication.

Responsibilities

• Act as the primary contact for external clinical data and laboratory data management activities across assigned studies.
• Collaborate with study teams to define external data collection, transfer, and integration strategies.
• Support reconciliation activities related to safety events and other critical clinical data.
• Partner with biostatistics, programming, clinical operations, safety, and other stakeholders to support study reporting and analysis needs.
• Coordinate external vendor and laboratory setup activities, including data transfer specifications.
• Ensure clinical databases are properly configured to support external data requirements.
• Review test data transfers from vendors prior to production use.
• Monitor external data flow and resolve discrepancies or quality issues.
• Serve as a liaison between sponsors, CROs, vendors, and internal teams regarding external data questions.
• Review laboratory reference ranges and associated documentation for completeness and accuracy.
• Maintain data transfer agreements, issue trackers, reconciliation logs, and study records.
• Review external data listings and address data queries and inconsistencies.
• Contribute to data management plans and study documentation related to external data processes.
• Generate and communicate study metrics, reconciliation status updates, and data quality trends.
• Participate in cross-functional meetings to support external data management activities.
• Recommend and implement process improvements related to data transfers and reconciliation workflows.
• Assist with KPI reporting, performance tracking, and training initiatives related to external data operations.

Skills

External data mgmt

Clinical data mgmt

ICH-GCP

FDA regulations

Data quality

Vendor management

Cross-functional team

Documentation

Communication skills

Education

Bachelor's degree

Life Sciences degree

Tools

CDISC

SDTM

CDASH

eCOA platforms

Job description

We are seeking an experienced External Data Management Specialist to support the collection, oversight, and integration of third-party clinical trial data throughout the study lifecycle. This individual will serve as a key point of contact for external data sources such as central and local laboratories, imaging vendors, ECG providers, PK data vendors, and other clinical service partners. The role focuses on ensuring data quality, regulatory compliance, and seamless collaboration across functional teams involved in clinical research.

Key Responsibilities

• Act as the primary contact for external clinical data and laboratory data management activities across assigned studies.
• Collaborate with study teams during protocol review and study startup to define efficient external data collection, transfer, and integration strategies.
• Support reconciliation activities related to safety events and other critical clinical data in accordance with established procedures.
• Partner with biostatistics, programming, clinical operations, safety, and other stakeholders to support study reporting and analysis needs.
• Coordinate external vendor and laboratory setup activities, including data transfer specifications and implementation planning.
• Ensure clinical databases are properly configured to support external data requirements.
• Review and validate test data transfers from vendors prior to production use.
• Monitor external data flow and proactively identify, investigate, and resolve discrepancies or quality issues.
• Serve as a liaison between sponsors, CROs, vendors, and internal teams regarding external data questions, transfer issues, and data validation concerns.
• Review laboratory reference ranges and associated documentation to ensure completeness and accuracy.
• Maintain documentation including data transfer agreements, issue trackers, reconciliation logs, and study-specific records.
• Review external data listings and collaborate with relevant teams to address data queries and inconsistencies.
• Contribute to data management plans and study documentation related to external data processes.
• Generate and communicate study metrics, reconciliation status updates, and data quality trends to stakeholders.
• Participate in cross-functional meetings to support external data management activities and risk mitigation efforts.
• Recommend and implement process improvements related to data transfers, laboratory data handling, and reconciliation workflows.
• Assist with KPI reporting, performance tracking, and training initiatives related to external data operations.

Qualifications

Required

• Bachelor's degree or equivalent combination of education and relevant industry experience.
• Experience supporting external clinical trial data management activities.
• Working knowledge of ICH-GCP, FDA regulations, and clinical research standards.
• Strong organizational skills with the ability to manage multiple priorities simultaneously.
• Excellent written, verbal, and interpersonal communication skills.
• Detail-oriented with a demonstrated ability to work independently and collaboratively in a cross-functional environment.

Preferred

• Degree in Life Sciences, Health Sciences, Biotechnology, or a related field.
• Experience working within a CRO, biotech, pharmaceutical, or clinical research environment.
• Familiarity with industry data standards such as CDISC, SDTM, and CDASH.
• Experience supporting data transfers from laboratories, imaging providers, ECG vendors, eCOA platforms, or other external clinical systems.

Ideal Background

• Clinical Data Management experience in biotechnology, pharmaceutical, or CRO settings.
• Hands-on experience managing external vendor data, laboratory data reconciliation, and data quality review.
• Comfortable working with multiple stakeholders across clinical operations, biostatistics, safety, and technology teams.
• Strong understanding of clinical trial data flow and vendor oversight processes.

This version removes company-specific references, proprietary terminology, and identifiable branding while preserving the core responsibilities and requirements of the role.