External Data Specialist – Contract

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Manage external and/or local laboratory data throughout the entire lifecycle of clinical trials.

• Adhere to departmental SOPs, guidelines, and global standards to uphold data integrity and consistency.

• Support the Clinical Data Management team with the review of local lab and external data documentation as well as quality control.

• Communicate data point discrepancies and validation issues to Clinical Data Managers, study teams, and management.

• Conduct quality control and data entry for laboratory normal ranges.

• Analyze study protocols and eCRF designs, suggesting methods for data aggregation and capture.

• Ensure that clinical databases are compliant with external vendor data requirements.

• Perform quality control on external data test transfers to confirm acceptance.

• Maintain logs for external data reconciliation and changes.

• Verify that normal ranges are correctly linked to patient results.

• Review vendor and laboratory data in elluminate, issuing queries or addressing data issues as necessary.

• Contribute insights to DMP, IDROP, and CCG documentation.

• Engage in study start-up, build, and IST activities.

• Create and perform quality control on specifications and visualizations for exception listings.

• Assist with external vendor data transfer agreements.

• Provide study-specific data metrics to Clinical Data Management, clients, and Project Management.

• Participate in internal and external study team calls as required.

• Collaborate across functions on study reporting and data trends to identify and mitigate risks.

• Assist the Manager of External Data by mentoring the Lab Admin team.

• Carry out other assigned responsibilities.

⛳️ Requirements

• A Bachelor of Science degree in a health-related field or an equivalent combination of education, training, and directly related experience is preferred.

• A Medical Laboratory Technology certificate is preferred.

• Strong command of the English language, both written and verbal.

• Familiarity with ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodology.

• Basic knowledge of medical terminology.

• Ability to maintain confidentiality regarding data and information.

• Capacity to work independently while managing multiple projects.

• Detail-oriented, capable of multitasking, and possessing strong organizational skills.

• Excellent communication abilities.

• Understanding of clinical data management processes and vendor data handling.

• A collaborative team player.

🏝️ Benefits

• Opportunity for remote work.

• Professional development and career advancement opportunities.

• Work-life balance.

• An inclusive, people-first culture.

• Equal opportunity employment.

• Recognition as a Top Workplace in the USA for Remote Work.