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 Physical Requirements 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. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. 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 [email protected] . 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