External Data Specialist (Contract)

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 helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.

eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate , throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions.

You will make an impact:

The External Data Specialist is responsible for the processing of external and/or local lab data received at eClinical Solutions throughout the clinical trial lifecycle. The External Data Specialist works to ensure departmental SOPs, guidelines and global standards are followed to maintain data integrity and ensure consistency across all assigned projects. The External Data Specialist will assist the Clinical Data Management team with local lab and/or external data documentation review and quality control for trial deliverables .

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.

Your day to day:

In addition to the duties outlined, performsadditionalduties and responsibilities based on developing skills and capabilities:

• Communicate to Clinical Data Manager, study team, and/or Manager, External Data problems involving local lab and/or vendor data point issues and validation issues
• Perform QC of laboratory normal ranges prior to entry to ensure documents received are ICH/CGP compliant andaccurate
• Perform Lab Normal Range data entry and/or 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 and insights into best approach for data aggregation and capture
• Ensure clinical database supports data requirements and is in alignment with external vendor data
• Perform QC of external data test transfers for acceptance
• Maintain external data reconciliation logs and/or change logs
• Verify the normal ranges are properly linked to the patient results in the local lab data collection module of the database
• Review external vendor data and/or local laboratory data listings viaelluminate® and issue queries or communicate data issues to internal and/or external team members
• Review and provide input to DMP, IDROP and CCG to ensure local lab normal range and/or external data process for assigned study is accurately documented
• Review study protocols and local lab and external data eCRF design in start-up, providing recommendations and insights into best approach for data aggregation and capture
• Ensure clinical database supports data requirements and is in alignment with external vendor data
• Perform local lab and external vendor associated study start-up and build activities
• Perform IST activities for local lab normal range population
• Develop the local lab and external data exception listing specifications and associated visualizations, and QC the output for movement to production
• Provide support for set-up and implementation of external vendor data transfer agreements
• Provide study specific local lab and/or external vendor data driven metrics to Clinical Data Management,Clientand/or Project Management
• Attend internal and external study team calls, as needed, for support of study specific local lab and external vendor data processes
• Work closely with cross-functional teams on study reporting and data trending via clinical data analytics technologies for local laboratory and/or external vendor data to proactivelyidentifyand mitigate risks
• Support Manager, External Data with Lab Admin team mentoring
• Other duties as assigned

Take the first step towards your dream career. Here is what we are looking for in this role.

Qualifications:

• Basic Science/Bachelor of Science degree in health-related field or an equivalent combination of education,traininganddirectly relatedexperience to successfully perform the key responsibilities of the jobpreferred
• Medical Laboratory Technology certificate preferred
• Excellent command of the English language (both written and verbal)
• Ability to maintain confidentiality of data and information during interactions with staff 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, ability to multitask, with strong organizational skills
• Knowledge of clinical data management processes and vendor data processing

Accelerate your skills and career within a fast-growing company whileimpactingthe future of healthcare. We have shared our story, nowwe look forward tolearningyours!

eClinical is a winner of the 2025 Top Workplaces USA Award for Remote Work! We have also receivednumerousTop Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. See all the details here: https://topworkplaces.com/company/eclinical-solutions/

eClinical Solutions is apeoplefirst organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect usand thatinspire innovation in our community. Our teamseeks outopportunities to learn,growand continuously improve. Bring your authenticself,you are welcome here!

We are proud to be an equal opportunity employer that values diversity.Our management team is committed to the principle that employment decisions are based on qualifications, merit, culturefitand business need.

Pay Range

US Pay Ranges

$85,000 - $110,000 USD