Clinical Data Manager

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.

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.

• 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.

• 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