Clinical Data Integrity & External Lab Specialist

eClinical Solutions, LLC; Mansfield (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

eClinical Solutions, LLC seeks an External Data Specialist to manage processing of external and local lab data across the clinical trial lifecycle, ensuring data integrity and compliance with SOPs and global standards.

You will support the Clinical Data Management team with data documentation review, quality control, and data transfer communications, while collaborating with cross-functional teams to improve data aggregation and reporting.

Qualifications

• Basic Science/Bachelor of Science degree in health-related field or equivalent.
• Medical Laboratory Technology certificate preferred.
• Excellent command of the English language (both written and verbal).
• Ability to maintain confidentiality of data and information at all levels.
• Understanding of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology.
• Basic understanding of medical terminology.
• Excellent team player and collaborator.
• Ability to work independently and manage multiple projects.
• Detail oriented with strong organizational skills.
• Knowledge of clinical data management processes and vendor data processing.

Responsibilities

• Communicate data issues to Clinical Data Manager, study team, and/or Manager, External Data involving local lab and vendor data.
• Perform QC of laboratory normal ranges prior to entry to ensure documents are ICH/CGP compliant and accurate.
• Perform Lab Normal Range data entry and QC, meeting processing deliverables on time and with quality.
• Review study protocols and local lab and external data eCRF design in start-up, providing recommendations for data aggregation and capture.
• Ensure clinical database supports data requirements and aligns with external vendor data.
• Perform QC of external data test transfers for acceptance.
• Maintain external data reconciliation logs and change logs.
• Verify normal ranges are properly linked to patient results in local lab data collection module.
• Review external vendor data and local lab data listings via elluminate and raise data issues.
• Provide input to DMP, IDROP and CCG to ensure documentation of lab ranges and external data processes.
• Develop local lab and external data start-up activities and build.
• Perform IST activities for local lab normal range population.
• Create data exception listings specifications and visualizations for transition to production.

Skills

English proficiency

Team collaboration

Multitasking

Independent work

Organizational skills

Clinical data management knowledge

Education

Bachelor's degree in health-related field

Medical Laboratory Technology certificate

Job description

eClinical Solutions, LLC seeks an External Data Specialist to manage processing of external and local lab data across the clinical trial lifecycle, ensuring data integrity and compliance with SOPs and global standards.

You will support the Clinical Data Management team with data documentation review, quality control, and data transfer communications, while collaborating with cross-functional teams to improve data aggregation and reporting.