Clinical Data Manager I — Data Integrity in Trials

Charles River Laboratories; Wilmington (MA); On-site; USD 64,000 - 68,000; Full time

Job summary

Charles River Laboratories in Massachusetts seeks a Clinical Data Manager I to oversee basic clinical trial data across multiple projects within Safety Assessment. You will ensure timely, accurate data reporting and coordinate with site operations and clients throughout the data life cycle.

This role requires a BS/BA, 3–5 years in research/pharma, and familiarity with CDISC CDASH/SDTM. Strong communication and organizational skills are essential.

Qualifications

• Education: Bachelor’s Degree (B.S./B.A.) in a scientific discipline preferred.
• Experience: 3-5 years in a research or pharmaceutical environment; data management experience preferred.
• Equivalent combination of education and experience may be accepted.
• Familiarity with CDISC’s CDASH, SDTM, and Controlled Terminology Standards.
• Familiarity with data output formats (.xml, .xpt, sas7bdat, ASCII, text, .DAT, .xlsx).
• Knowledge of Microsoft Office Suite and ability to meet deadlines.
• Excellent communication (written and verbal) and collaboration skills.
• Ability to interact with clients and all levels of employees; support departmental teams.

Responsibilities

• Request requirements from the sponsor for data transfer frequency and dataset architecture.
• Prepare and/or review Data Transfer Agreements for basic assay data types.
• Oversee preparation of the Study Data Tabulation Model (SDTM) and non‑SDTM datasets.
• Perform quality control on the clinical study, including regulatory compliance and data corrections.
• Confirm datasets are prepared and transferred to the sponsor in compliance with regulations.
• Support peers in secondary document review and quality control activities.
• Transfer datasets using approved data portal locations.
• Attend and/or host internal or external meetings.
• Keep stakeholders informed of strategy, plans and changes.
• All other duties as assigned.

Skills

BS/BA in scientific discipline

3-5 years in research/pharma

CDISC CDASH/SDTM familiarity

Data management and data formats

Excellent communication & organization

Education

Bachelor’s Degree in scientific discipline

Tools

CDISC SDTM

Data formats (XML, SAS7BDAT, ASCII)

Microsoft Office

Job description

Charles River Laboratories in Massachusetts seeks a Clinical Data Manager I to oversee basic clinical trial data across multiple projects within Safety Assessment. You will ensure timely, accurate data reporting and coordinate with site operations and clients throughout the data life cycle.

This role requires a BS/BA, 3–5 years in research/pharma, and familiarity with CDISC CDASH/SDTM. Strong communication and organizational skills are essential.