- Location
- Bangalore_40, India
- Workplace
- Hybrid
- Type
- Full-time
- Department
- Education
- Experience
- 2+ years
- Education
- Bachelor
- Source
- Workday
Description
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.
What You'll Be Doing:
- Interacts with internal and external project team members, including external data source vendors, across multiple projects.
- Contributes to study team discussions, meeting agendas, attendance, and documentation of minutes.
- Facilitates clinical database development including eCRF planning, edit check identification, User Acceptance Testing, and external data source coordination.
- Participates in data risk assessment and continuous evaluation of risks throughout the study.
- Coordinates with data team members to ensure tasks are executed per study plans and timelines.
- Ensures training on study-specific protocol requirements and supports training of data reviewers.
- Creates, maintains, executes, and stores data-related documentation per department procedures.
- Responsible for functional area eTMF filing and quality control activities.
- Participates in internal and external study audits as required.
- Oversees study budget, identifies out-of-scope activities, and supports re-scoping.
- Responsible for generation, review, and reporting of study metrics and financials.
- Executes all tasks aligned with SOPs, department guidelines, and data standards.
What We Are Searching For:
- Bachelor's Degree, preferably in a Life Science, required; Post Graduate preferred.
- 5–8 years of Data Management or relevant industry experience, with at least 2 years leading studies.
- Experience with at least two clinical data management systems and in-depth knowledge of at least one, preferably Medidata Rave or DataLabs EDC.
- Familiar with all phases of a study, e.g., startup/database set-up, maintenance, and lock.
- Exposure to automation tools and AI-driven solutions in clinical data management, with the ability to support or drive implementation of automation and AI initiatives to improve data quality, efficiency, and cycle times.