Senior Data Manager
1 month ago
Job Overview
The Senior Data Manager will be responsible for overseeing all data management activities in large, complex studies. This role requires a strong understanding of data management principles and practices, as well as excellent communication and organizational skills.
Key Responsibilities
- Provide general oversight on all Data Management activities on large complex global studies
- Communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting
- Coordination of data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables.
- Primary responsibility for clinical data management activities within clinical projects, including, but not limited to:Reviews and approvals, escalation point and troubleshootingInvolved in audits and inspectionsSupporting with SOP development and process improvementsProvide input into Proposals, Budgets and Bid Defense meetingsClinical database lockCoordination and supervision of processing, dispatch and archiving of CRFs/queries
- Input into design of CRFs and other data collection forms; review Case Report Form design for accuracy and adherence to protocol
- Development of CRF completion guidelines
- Coding medical data with coding dictionaries and coding listings review (Lead DMs with medical/biology background, additional training required)
- Electronic data transfer (import/export) specifications review and approval
Requirements
- College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities
- Significant experience of full scope of data management responsibilities in international EDC studies
- Experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable)
- Full working proficiency in English
- Organizational and managerial skills
About PSI
PSI is a leading provider of clinical research services. We are committed to delivering high-quality data management solutions to our clients. If you are a motivated and experienced data management professional, we encourage you to apply for this exciting opportunity.
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