Note: The job is a remote job and is open to candidates in USA. Charles River Laboratories is a contract research organization supporting drug development through safety assessment, clinical laboratory testing, and related services. The Supervisor Clinical Data Management role oversees staff and daily departmental processes, ensures quality and timely delivery of clinical data management work, supports process improvements, and coordinates with clients and internal teams.
Responsibilities
- Responsible for personnel management activities such as scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews
- Act as point of contact for site Operations and/or Scientific for questions on Clinical Data Management deliverables
- Review and revise staff availability in alignment with the Clinical Data Management schedule
- Coordinate with applicable staff on answers to client's comments on shipped data packages
- If needed, assist staff to get Scientist and/or Study Director input on needed information to complete data package
- Alert management and responsible site study personnel of risks to delivery timelines
- Ability to work independently and to escalate issues to management as required
- Oversee daily operational activities and supervise assigned employees to ensure optimum group performance
- Recommend short-range departmental objectives, organizational structure, staffing requirements, and succession plans
- Participate in departmental and global initiatives to implement or improve processes
- Attend and/or host internal or external meetings as appropriate
- Mentor and train staff in support of business needs and team development
- Develop, implement, and maintain data or process tools
- Draft and/or update relevant SOPs and other procedural documents
- Support the Manager as needed with administrative activities
- All other duties as assigned
Skills
- * Education: Bachelor's Degree (B.S./B.A.); scientific discipline preferred
- * Experience: Minimum of four (4) years' experience in the pharmaceutical and/or biotechnologybased industry in GLP or GCP environment. Experience in supervisory/management preferred
- * An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
- * Certification/Licensure: No specific certifications or licensure required
- * Other: Knowledge of CDISC's CDASH, SDTM, and Controlled Terminology Standards. Knowledge 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. Familiarity with data analytics software (E.g. SAS), experience in use of SAS is a bonus
- * Other: Knowledge of CDISC's CDASH, SDTM, and Controlled Terminology Standards. Knowledge 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. Familiarity with data analytics software (E.g. SAS), experience in use of SAS is a bonus
- * Other: Excellent organizational skills and the ability to meet deadlines
- * Other: Excellent communication (both written and verbal), leadership and negotiation skills
- * Other: Ability to interact appropriately with clients and all levels of employees, while at the same time supporting the efforts of departmental teams
- Four-year degree required
Benefits
- Bonus/incentives based on performance
- 401K
- Paid time off
- Stock purchase program
- Health and wellness coverage
- Employee and family wellbeing support programs
- Work life balance flexibility
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