Job Description

Join to apply for the Senior Clinical Data Manager role at Katalyst CRO 4 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Leads a large clinical study or a series of related studies with minimal guidance. Represents Data Management at study management team meetings. Provides mentoring and training to lower-level Data Management staff assigned to his/her studies. Manages and monitors the progress of data management activities with CROs or other vendors on assigned studies; builds effective relationships with CRO/vendor counterparts. Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design. Performs a detailed review of eCRF data requirements and creates one if needed. Interacts with CRAs, programmers, study operations leads, and statisticians in designing eCRFs and creating annotated eCRFs and CRF completion guidelines. Leads the development of data edit check specifications and data listings. Coordinates the design and testing of Electronic Data Capture (EDC) systems according to company processes. Resolves EDC system issues with team members. Develops or leads the development of the Data Management Plan for a clinical study. Reviews and provides feedback to the clinical team on other study documents such as Statistical Analysis Plans and vendor specifications. Provides training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed. Performs reconciliation of data from external sources against the clinical database. Performs Serious Adverse Event reconciliation activities according to SOPs and guidelines. Leads database upgrades/migrations including performing User Acceptance Testing. Performs database lock and freeze activities per company SOPs. Performs miscellaneous duties as assigned. Responsibilities Leads a large clinical study or related studies with minimal guidance. Represents Data Management at study management team meetings. Mentors and trains lower-level Data Management staff. Manages data management activities with CROs/vendors and builds relationships. Reviews protocols for data capture, including eCRF design. Reviews eCRF data requirements and creates eCRFs if needed. Collaborates with CRAs, programmers, and statisticians on eCRF design and guidelines. Develops data edit check specifications and data listings. Coordinates EDC system design and testing. Resolves EDC issues with team members. Develops or leads Data Management Plans. Reviews and provides feedback on study documents. Trains staff on EDC and eCRF guidelines. Reconciles data from external sources. Performs Serious Adverse Event reconciliation. Leads database upgrades/migrations and UAT. Performs database lock and freeze activities. Performs other duties as assigned. Requirements Bachelor's Degree in scientific/healthcare field with 9 years of experience. Master's degree with 7 years or PhD with 4 years of experience preferred. Good project management skills and multitasking ability. Understanding of regulatory guidelines and industry standards (e.g., ICH/FDA, CDISC, GCDMP, 21 CFR 11, MedDRA, WHO Dictionaries). Attention to detail and strong communication skills. Experience with oncology studies. Ability to travel for meetings or training. Strong computer and technical skills, ability to learn multiple applications. Experience with Data Management systems and EDC systems is desirable. Seniority level Mid-Senior level Employment type Contract Job function Information Technology Industries Pharmaceutical Manufacturing #J-18808-Ljbffr Katalyst CRO

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