Senior Clinical Data Analyst

We work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart(R).

About the Role

We are seeking a Senior Clinical Data Analyst to join our team in India, Hybrid capacity. As a Clinical Data Management Associate, you will support clinical research activities that advance new treatments for patients. This position plays a key role in study execution, patient safety oversight, regulatory compliance, and clinical data accuracy. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to study operations from planning through closeout.

Your responsibilities will include database design and management, data quality oversight, vendor coordination, and regulatory compliance activities. You'll work in a fast-paced, growth-oriented environment focused on delivering high-quality clinical data that drives regulatory submissions and patient safety. With diverse teams and continuous learning opportunities, the Clinical Data Management Associate can explore career paths and expand skills across clinical research and data management.

Key Responsibilities

• Support the Data Management Lead in study planning, execution, and project management activities

• Draft EDC build timelines and perform database and edit check specification activities

• Conduct user acceptance testing (UAT) for database, coding, site payment, and safety integrations

• Create and maintain study documents and ensure proper filing in the electronic Trial Master File (eTMF) per study requirements

• Coordinate data review activities, manage vendor deliverables, and support Data Quality Review meetings

• Manage post-production activities, data migration, and database lock to ensure regulatory compliance and study timelines

• Provide training and mentoring to junior Clinical Data Management staff and support cross-functional study teams

You'll thrive in this role if you bring:

• Expertise in end-to-end clinical data management, including protocol review, CRF/eCRF design, and database lock

• Advanced proficiency with EDC systems, particularly Medidata RAVE and Oracle Clinical

• Strong skills in data review, query management, query trend analysis, and data quality oversight

• Experience working in clinical research, healthcare, or a regulated environment

• The ability to collaborate across teams and communicate clearly with stakeholders at all levels

• A patient-focused mindset and strong attention to detail in managing complex clinical data

• Comfort working with electronic data capture systems, eTMF platforms, and clinical trial management tools

Required Qualifications

• 8 or more years of end-to-end clinical data management experience from protocol review through database lock

• Hands-on experience with Medidata RAVE and Oracle Clinical EDC systems

• Knowledge of ICH-GCP, FDA guidelines, and clinical trial processes

• Demonstrated expertise authoring and reviewing data management documents (DQMP, DVP, DRP, PDRP, eCRF Completion Guidelines)

• Strong communication, organization, and problem-solving skills

Preferred Qualifications

• Experience overseeing CRO or CDM vendors and managing study deliverables within timelines

• Experience supporting audits, inspections, and regulatory submissions

• Project management and metrics reporting experience in clinical research environments

• Mentoring and leadership experience with junior data management staff

If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.