Full-Time Lead Data Manager

Lead Data Manager Responsibilities:

The Lead Data Manager will manage all data activities in complex studies, or lead smaller/medium sized projects under minimal supervision. Key responsibilities include:

• Data Management Coordination: EDC development, data collection, cleaning, reconciliation, database lock, final database creation.
• Study Document Review: Reviewing study documents, plans, guidelines.
• Data Management Plan Development: Developing and reviewing project-specific guidelines.
• User Acceptance Testing: Coordinating/performing user acceptance testing.
• Data Validation: Developing data validation plans, conducting automatic and manual inspections, resolving discrepancies, generating queries, providing feedback to teams.
• Non-CRF Data Handling: Managing non-CRF electronic data (receiving, archiving, loading, reconciliation).
• Database Edits: Performing database edits (paper CRF studies).
• CRF Review: Reviewing and verifying CRF design and completion guidelines.
• Data Coding: Coding medical data with dictionaries/listings.
• SAE Reconciliation: Reconciling Serious Adverse Events.
• Electronic Data Transfer: Reviewing and approving data transfer specifications.
• Document Management: Liaison with Document Center for TMF/eTMF maintenance.
• Quality Control: Performing database QC checks and documentation.
• Audits: Participating in internal, client, and 3rd-party audits.
• Training: Training Assistant Data Managers, investigators, and clinical teams.
• Meetings: Preparing and attending investigator meetings, client/vendor meetings.

Qualifications:

• College/University degree or equivalent experience.
• 3+ years of data management experience in international EDC studies.
• 2+ years of CDM/EDC system experience (Medidata Rave or Oracle Inform preferred).
• Skills: Strong understanding of clinical data management principles, EDC/CDM systems, data validation, and audit processes.
• Fluency in English.
• Strong organizational and managerial skills.

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