Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Lead Data Manager
Posted: 01/30/2025
2025-01-30
2025-03-12
Employment Type:
Contract
Job Category: Data Sciences
Job Number: 617207
Is job remote?: Yes
Country: United States
Job Description
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Essential Functions:
Necessary Skills and Abilities:
Educational Requirements:
Experience Requirements:
Essential Functions:
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Acts as the Data Management program leader by ensuring consistency between studies for a sponsor, monitoring study timelines, evaluating, and mitigating project risks and reporting/reconciling project budgets.
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May act as the Lead Data Manager for one or multiple studies.
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Completes Data Management tasks for assigned studies under supervision according to the study contract and applicable SOPs.
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Develops and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, add Data Transfer Specifications, Coding Guidelines, Postproduction Database Change Control Documentation, Database Audit and Lock Procedures.
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Works with database programmers to design (e)CRFs and edit checks in EDC system.
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Creates test data for User Acceptance Testing (UAT).
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Performs and document database UAT.
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Receives, integrates, and reconciles electronic data.
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Performs data review via listings and EDC system, issue and resolve queries.
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Manages queries to ensure data completeness and integrity.
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Assists with data listing design for data review.
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Performs SAE reconciliation.
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Performs pre-lock and data lock tasks.
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Participates in client and team meetings as required.
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Designs, generates, and reviews status metric reports as needed.
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Performs archiving of study databases and related documents.
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Provides input to timelines to ensure timely completion of assigned tasks.
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Provides regular status updates and keeps the team and management informed of any changes.
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Organizes and file study documentation.
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Works with management and senior DM personnel to implement technical solutions and resolve issues.
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Trains and mentors data management staff, acts as a subject matter expert.
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Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences.
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Maintains knowledge of regulatory guidelines and industry standards applicable to clinical studies with specific emphasis on data management activities.
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Provides input to SOPs as relevant to all data management activities.
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Other duties as assigned.
Necessary Skills and Abilities:
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Excellent communication and time management skills.
Educational Requirements:
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Minimum BS in a scientific or health related field or the equivalent in years of experience.
Experience Requirements:
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Minimum 10 years in Clinical Data Management.
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Minimum 5 years acting as a Lead Data Manager on one or multiple projects (study start up through database lock).
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