06 Aug
|
Remidio
|
Bengaluru
Who this role is for -
You are an industry-trained clinical operations skilled who takes pride in clean data, disciplined execution, and audit-ready studies. This is a hands-on role and you will independently run studies. This role exists to ensure that every dataset we generate is accurate, traceable, locked, and trusted. Your job is to make the data bulletproof.
End-to-end clinical operations
Manage the execution of clinical trials to ensure adherence to protocols and regulatory requirements
Supervise and coordinate clinical coordinators/SRAs/data collectors for effective study site selection, initiation, monitoring, and close-out.
Enrollment tracking and operational timelines.
Day-to-day problem solving across sites
Owning delivery — not escalating issues.
Data governance & quality (primary focus)
Own EDC / CTMS / eTMF workflows.
Support risk-based quality management (RBQM) and own centralized monitoring activities
• Define and enforce data quality standards. • Own query management, audit trails, and database lock.
Ensure source dataset traceability.
Audit readiness & compliance (practical)
Ensure real-world compliance with GCP, ICH, ISO 14155.
Own deviations, CAPAs, and inspection readiness.
Maintain SOP discipline.
Collaboration with scientific leadership
Work closely with the Clinical Lead to ensure data supports scientific objectives.
Enable science by delivering reliable data.
What we are looking for
Industry experience in clinical operations (medical devices strongly preferred).
Hands-on ownership of data quality.
Strong experience with EDC/CTMS systems.
Comfortable running multicenter studies independently.
Contribute towards clinical regulatory documents
Secondary/ nice to have would be compose clinical protocols, scientific manuscripts, concept notes for research purposes and do basic statistical analysis (SPSS/SAS/ R)
Mindset
Execution-obsessed, detail-oriented
Solid ownership instinct — “this is my dataset.”
Low tolerance for sloppy processes or shortcuts.
Enjoys solving messy, real-world problems.
📌 Clinical Operations & Data Quality Manager Bengaluru
🏢 Remidio
📍 Bengaluru