Premier Research is looking for a Senior Data Coordinator - DM to join our Clinical Data Sciences team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
This is a hybrid role based out of our Bangalore office
What you'll be doing
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 the 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 to ensure data accuracy, completeness, and consistency with study protocols, CCGs, DMPs, and applicable procedures.
- Generate and manage data queries with appropriate 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 activities for moderately to highly complex studies and vendor data types.
- Act as a 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 activities related to database set-up.
- 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 a subject matter expert for EDC systems and Data Coordinator activities, providing guidance and support to the wider team.
What we are looking for
- 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.
