Clinical Data Manager I

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

At Charles River, we are passionate about improving the quality of people’s lives. When you join our global family, you will help create healthier lives for millions of patients and their families.

Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career.

As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life‑saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe.

Job Overview

A Clinical Data Manager I is responsible for managing basic clinical trial data for multiple assigned projects conducted across all Charles River Safety Assessment. Additionally, a Clinical Data Manager is responsible to ensure clinical trial data are reported accurately and on time as per the applicable driving documents and standards. A Clinical Data Manager coordinates with Charles River Safety Assessment site operations and clients throughout the clinical data life cycle.

Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Request requirements from the sponsor for transfer frequency and dataset architecture for data transferred to sponsors in support of clinical study work.
• Prepare and/or review Data Transfer Agreements for basic assay data types (E.g. PK, Biomarker).
• Oversee preparation of the Study Data Tabulation Model (SDTM) and non‑SDTM datasets for a clinical study.
• Perform quality control on all aspects of the clinical study as appropriate, to include, but not be limited to clinical regulatory compliance, Data Transfer Agreements, creation of clinical programming specifications, review of external client(s) clinical study documentation, review and management of data corrections via reconciliation requests from external client(s).
• Confirm clinical datasets are prepared and transferred to the sponsor in compliance with applicable regulations.
• Support peers in secondary document review and quality control activities for their assigned projects.
• Transfer datasets utilizing acceptable data exchange locations, such as internal or external data portal locations.
• Attend and/or host internal or external meetings as appropriate.
• Keeps internal and external stakeholders informed of strategy, plans and changes as needed to provide quality products and services.
• Responsible for assigned study schedules and for coordinating internal and external resources.
• All other duties as assigned.

Qualifications

• Education: Bachelor’s Degree (B.S./B.A.); scientific discipline preferred.
• Experience: 3-5 years in a research or pharmaceutical environment; data management experience preferred.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Familiarity with CDISC’s CDASH, SDTM, and Controlled Terminology Standards.
• Familiarity with various data output formats (.xml, .xpt, sas7bdat, ASCII, text, .DAT, .xlsx).
• Knowledge of Microsoft Office Suite and ability to perform basic computer functions commensurate with the job responsibilities. Excellent organizational skills and the ability to meet deadlines.
• Excellent communication (both written and verbal), and collaboration skills.
• Ability to interact appropriately with clients and all levels of employees, while at the same time support the efforts of departmental teams.
• Certification/Licensure: No specific certifications or licensure required

Compensation Info

The pay range for this position is $64,000 - $68,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Education

Four-year degree required

About Safety Assessment

Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state‑of‑the‑art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

About Charles River

Charles River is an early‑stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non‑GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

Equal Employment Opportunity

Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e‑mail message to [e-mail]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

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