Clinical Data Manager I

About the role

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.

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.
• 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.

Pay

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.

Schedule

Not specified.

Benefits

Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

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 crrecruitment_US@crl.com. 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.