Senior Data Coordinator - DM

Overview

Senior Data Coordinator supporting clinical data management for biotech, medtech and specialty pharma studies within the Clinical Data Sciences team.

What you'll do

• Prepare and maintain clinical data management documentation, including CRF Completion Guidelines (CCGs), Data Management Plans (DMPs), Data Report Specifications, Edit Check Specifications, and External Data Transfer Specifications, with minimal oversight.
• Support development of standard test data for testing database screens and listings, provide feedback on test results, and perform User Acceptance Testing (UAT), including edit check testing.
• Assist with clinical database set-up, maintenance, updates, and related data management activities.
• Review CRFs, data listings, and clinical databases for accuracy, completeness and consistency with study protocols, CCGs, DMPs and applicable procedures.
• Generate and manage data queries with internal and external stakeholders, including investigational sites, Clinical Research Associates (CRAs) and client representatives, to resolve data discrepancies.
• Review query responses and resolve outstanding data discrepancies.
• Perform external data and Serious Adverse Event (SAE) reconciliation, including for moderately to highly complex studies and vendor data types.
• Act as Lead Data Coordinator and/or Safety Reviewer across multiple studies, coordinating data management activities and ensuring consistency and efficiency across assigned studies or portfolios.
• Perform document submissions to the Trial Master File (TMF) and support TMF Quality Control (QC) activities, potentially serving as the primary resource for this activity.
• Perform database QC activities and quality checks of study reports and electronic Case Report Form (eCRF) PDF files.
• Support Data Scientists and Project Managers with financial project statistics, study metrics, dashboards and project status reporting.
• Provide back-up support to the Lead Data Scientist, as required, including database set-up activities.
• Collaborate regularly with Data Scientists and cross-functional project team members, with potential direct client interaction.
• Coordinate and complete assigned activities in accordance with study plans, project requirements and timelines.
• Train and mentor newer Data Coordinator team members and deliver relevant training sessions.
• Serve as subject matter expert for EDC systems and Data Coordinator activities, providing guidance and support to the wider team.

What you'll need

• Bachelor's degree or above, preferably in Life Sciences.
• Minimum 4 years of Data Management or related clinical research industry experience.
• Experience working with at least two Clinical Data Management Systems (CDMS), with in-depth knowledge of at least one, such as Medidata Rave or DataLabs EDC.
• Familiarity with all phases of clinical study, including database set-up, maintenance and database lock.
• Strong communication, organizational and time management skills.
• Ability to manage multiple studies as a Lead Data Coordinator while working effectively with cross-functional study teams.
• Accountable and dependable, with a strong commitment to data quality and timely delivery.

Details

• Hybrid role based out of the Bangalore office.