Senior Data Manager

Position Overview

• Location Type: Remote
• Employment Type: Full time
• Salary: Not provided

The Senior Data Manager ensures DM tasks for the assigned studies are performed on time and within budget, partners with Sponsors, clinical and statistics to develop the data collection specification from all data sources. The Senior Data Manager manages in-stream data flow activities and deliver a quality database in accordance with the project plan, leads and drive 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.

Requirements

• Not provided

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 and guide 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 EDC studies, define the User Acceptance Test Plan (UAT) and execute the 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 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 study project plan and escalate issues to resolution at the appropriate level.
• Demonstrate good application of document management process and proc.
• Effectively contribute in formal training for new starters.