External Data Specialist (Contract)

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, performs additional duties 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 and accurate  

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 via elluminate® 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, Client and/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 proactively identify and 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, training and directly related experience to successfully perform the key responsibilities of the job preferred

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

Strong communication skills

Knowledge of clinical data management processes and vendor data processing  

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!  

eClinical is a winner of the 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top 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 a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, 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, culture fit and business need. Pay Range 

US Pay Ranges $85,000 — $110,000 USD