Join to apply for the Senior Manager Clinical Data Manager role at Katalyst CRO . Get AI-powered advice on this job and more exclusive features. Responsibilities Lead large clinical studies or series of related studies with minimal guidance. Represent Data Management in study management team meetings. Mentor and train lower-level Data Management staff. Manage and monitor data management activities with CROs or vendors; build effective relationships. Review protocols for appropriate data capture, including eCRF design. Perform detailed review of eCRF data requirements and create eCRFs as needed. Collaborate with CRAs, programmers, study operations, and statisticians in designing eCRFs and creating guidelines. Lead development of data edit check specifications and data listings. Coordinate design and testing of EDC systems per company processes. Resolve EDC system issues. Develop or lead the development of the Data Management Plan. Review and provide feedback on study documents like statistical analysis plans. Train on EDC systems and eCRF completion guidelines. Perform data reconciliation from external sources and Serious Adverse Event reconciliation activities. Lead database upgrades/migrations and perform UAT. Perform database lock and freeze activities. Adhere to company values, policies, procedures, and ethics. Perform miscellaneous duties as assigned. Requirements Master's degree with 7 years of experience or PhD with 4 years of experience (preferred). Strong project management skills and ability to multitask. Understanding of regulatory guidelines and industry standards (e.g., ICH/FDA, CDISC, GCDMP, 21 CFR 11, MedDRA, WHO Dictionaries). Attention to detail, strong communication skills, ability to work independently and in teams. Experience with oncology studies preferred. Ability to travel for meetings or training. Solid computer skills and experience with Data Management and EDC systems. Additional Details Seniority level: Mid-Senior level Employment type: Contract Job function: Information Technology Industry: Pharmaceutical Manufacturing #J-18808-Ljbffr Katalyst CRO
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