Senior Data Manager

Employment Type: Full time

Position Overview

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

The Senior Data Manager ensures Data Management (DM) tasks for assigned studies are performed on time and within budget. They partner with Sponsors, clinical teams, and statistics to develop data collection specifications from all data sources. The Senior Data Manager manages in-stream data flow activities, delivers a quality database in accordance with the project plan, leads and drives the DM team, and acts as the reference point for the Sponsor and the appointed person responsible for the project from the data management perspective.

Key Responsibilities

• Accountable for driving achievements of project milestones from study start-up through to delivery of database.
• Provide Data Management input into the protocol.
• Design the Case Record Form (CRF) and guide the process for CRF approval.
• Define and develop the Data Management Plan, Data Validation Plan, and their annexes (e.g., Reconciliation Plan), with input from the study team.
• Validation of the database and computerized checks, including SAS listings or SAS checks.
• For Electronic Data Capture (EDC) studies, define the User Acceptance Test (UAT) Plan and execute test activities in the test environment to ensure quality eCRF.
• For EDC studies, provide 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 the Quality Control (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 processes and procedures.
• Follow Standard Operating Procedures (SOPs) and guidance documents, as well as applicable industry standards like ICH, GCP, etc., in day-to-day activities.
• Make recommendations for process improvements and development of new standards.
• Develop and maintain a network of contacts within the study team.
• Maintain continuous and appropriate communication with sponsors.

Company Information

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.