[Hiring] External Data Specialist @eClinical Solutions

Role Description

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.

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.
• 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.

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.

Pay Range

US Pay Ranges: $85,000 — $110,000 USD