Senior Clinical Data Manager
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Miami, FL 33186
Description:
Responsibilities:
- Lead development of the clinical data management documentation for clinical studies using electronic data capture methods, data management plans, CRF designs, data dictionaries, data validations, data specifications, acceptance criteria, and data transfer agreements.
- Execute clinical data management activities throughout study lifecycle, such as supporting site initiation activities, reconciling electronic data transfers, validating data quality, preparing data for statistical review and/or data management audit, performing database lock and freeze activities, coordinating the archiving of study databases and related documents, and performing close out audits.
- Serve as liaison with Clinical Affairs to ensure robust data transfer and data quality processes are implemented and followed such as data acceptance criteria and data transfers.
- Develop database clinical trial data specifications and ensure compliance throughout study lifecycle, including eCRF design, user requirements, edit rules/checks, query logic, and data validations.
- Collaborate with study team members within data management, data automation, biostats and clinical affairs to execute study activities, improve processes, and generate Client solutions where required.
- Bachelor's degree 5+ years relevant experience or master's degree with 3+ years of experience or Doctoral degree with 0-2 years of experience in Computer Science, Mathematics, Statistics, Pharmaceuticals Sciences, Life Sciences or related fields.
- Knowledge of EHR and EDC (Medidata Rave is a plus) data sources, clinical data management roles and activities, such as developing and executing clinical data management documentation, developing study dataset specifications, working with CDISC, etc.
- Proficient in Excel, communication, executing trainings, data presentation, problem solving, and professional writing (data management plans, procedure, work instructions, etc).
- Previous work experience in a diagnostic, medical device or pharmaceutical fields.
- Experience using a high-level programming language such as R, Python, SQL for complex data analysis and reproducible research practices.
- Understanding of validation requirements for software tools.
- Knowledge and programming skills in Medidata Rave.