Senior Data Manager

Position Overview

• Location Type: Global (Remote/Hybrid - details not provided)
• Employment Type: Full-time
• Salary: Not provided
• Summary: The Senior Data Manager ensures Data Management tasks for assigned studies are performed on time and within budget, partnering with Sponsors, clinical, and statistics teams to develop data collection specifications from all data sources. They manage in-stream data flow, deliver a quality database, lead the DM team, and serve as the primary reference point for the Sponsor regarding data management.

Responsibilities

• Drive achievements of project milestones from study start-up through database delivery.
• Provide Data Management input into the protocol.
• Design the Case Record Form (CRF) and guide the CRF approval process.
• Define and develop the Data Management Plan, Data Validation Plan, and their annexes (e.g., Reconciliation Plan) with input from the study team.
• Validate the database and computerized checks, including SAS listings or SAS checks.
• For EDC studies, define the User Acceptance Test Plan (UAT) and execute test activities in the test environment to ensure quality eCRF.
• For EDC studies, timely response to issues identified by the eCRF Helpdesk.
• Prepare CRF completion guidelines.
• Prepare study-specific data-entry guidelines and train data-entry staff.
• Perform term coding for clinical studies, raise manual queries for uncoded terms as required.
• Query management: review discrepancies, review answered queries, resolve and close where appropriate, manage the data cleaning process including manual checks and Medical Review listings.
• Create and test import programs for electronic data received from external vendors.
• Perform timely data integration of CRF and non-CRF data (data import from external sources).
• Perform reconciliation of external data (e.g., SAE, Central Labs, ECGs, etc.).
• Run and monitor study data progress reports including query management and take appropriate actions (e.g., escalation, re-training, etc.), escalate any study issues within the study team.
• Define and execute QC plan, lead and execute database release and database freeze activities.
• Lead the DM team, coordinate other DM staff providing direction regarding work assignment, scheduling, and prioritizing.
• Input into and monitor progress against the study project plan and escalate issues to resolution at the appropriate level.
• Effectively contribute in formal training for new starters.
• Demonstrate good application of document management process.

Requirements

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Application Instructions

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Company Information

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