Senior Manager - Full Stack Developer- Clinical Data Operation

Initial Therapeutics, Inc.; India; On-site; INR 1,500,000 - 2,500,000; Full time

Benefits offered by this job

Annual bonuses or other incentive plans

Health and wellness programs

401(k) company match

Paid time off

Job summary

Initial Therapeutics, Inc. is seeking a Senior Manager Clinical Data Solutions & Insights to lead the design and delivery of a centralized reporting platform. This role is critical for ensuring data-driven decision-making in clinical research.

Located in Hyderabad, the ideal candidate will have over 8 years of experience in Clinical Data Management and will work collaboratively with cross-functional teams to deliver insightful reporting solutions.

The position offers a competitive salary and comprehensive benefits package.

Qualifications

• 8+ years of experience in Clinical Data Management or clinical trial operations.
• Minimum 3+ years focused on clinical data reporting, analytics, or reporting tool development.
• Hands-on experience with Medidata Rave EDC including query management workflows.
• Solid understanding of CDISC CDASH/SDTM standards and GxP/CSV validation principles.

Responsibilities

• Designing a centralized clinical reporting platform consolidating outputs.
• Building Clean Patient Tracker applications for real-time access.
• Developing executive-level dashboards highlighting portfolio-wide KPIs.
• Collaborating with Clinical Sciences for validated analytical tools.

Skills

Clinical Data Management

Analytics

Stakeholder management

Problem-solving

Data visualization tools

Python frameworks

Education

Bachelor's or Master's degree in Computer Science, Data Science, Bioinformatics, or a related field

Advanced degree (MBA/MS)

Tools

Medidata Rave EDC

Power BI

Tableau

SQL

Job description

About Regeneron

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health.

Senior Manager Clinical Data Solutions & Insights

As a Senior Manager Clinical Data Solutions & Insights, you will be responsible for designing, building, and handling a centralized clinical reporting platform that consolidates reporting outputs across Data Management and external vendor reconciliation activities into a single governed reporting layer. This role will be responsible for the end‑to‑end reporting lifecycle including data ingestion, analytical dataset development, dashboard creation, automated reporting, and self‑service analytics applications using modern visualization and web technologies.

You will work closely with Clinical Sciences, Data Management, Pharmacometrics, Precision Medicine, Safety, and multi‑functional collaborators to deliver intuitive, audit‑ready reporting solutions that support data‑driven decision making, regulatory compliance, and operational perfection.

Location

This position is office‑based and will be on site at Regeneron's Hyderabad office.

A Typical Day May Include

• Owning the design and delivery of a centralized clinical reporting platform consolidating EDC listings, exception reports, and vendor reconciliation outputs.

• Building and maintaining Clean Patient Tracker applications providing real‑time access to CRF completion, visit status, data queries, freeze/lock status, and PI signature status.

• Developing executive‑level dashboards highlighting portfolio‑wide KPIs such as query aging, protocol deviations, data entry lag, and study completion achievements.

• Partnering with Data Management Reporting teams and external vendor delivery teams to establish structured data ingestion pipelines for EDC and reconciliation reports.

• Collaborating with Clinical Sciences, Biostatistics, Safety, and Precision Medicine teams to develop validated self‑service analytical tools and reporting applications.

• Designing and implementing data visualization standards, UX/UI guidelines, and reporting procedures for non‑technical stakeholders.

• Building curated analytical datasets and semantic layers connected to clinical data lakes and vendor reconciliation feeds.

• Running the full reporting lifecycle including requirements gathering, UX wireframing, development, validation, UAT coordination, and production deployment.

• Driving automation across routine reporting workflows including scheduled data ingestion, reconciliation report generation, and alert‑based notifications.

• Supporting GCP compliance, inspection readiness, report governance, version control, and audit trail management.

• Driving adoption of reporting tools through stakeholder engagement, training, and change management initiatives.

• Serving as an SME for clinical data reporting, embedded analytics, and emerging visualization technologies.

This Role May Be For You If You Have:

• Demonstrable experience in Clinical Data Management, clinical trial reporting, analytics, or reporting platform development.

• Hands‑on experience with Medidata Rave EDC including query management workflows and dataset structures.

• Solid understanding of CDISC CDASH/SDTM standards and GxP/CSV validation principles.

• Experience developing reporting applications using Python frameworks such as Dash, Streamlit, or Flask.

• Demonstrable experience with Power BI, Tableau, SQL, and analytical dataset development.

• Experience working with clinical data sources, clinical metrics, and external vendor reconciliation outputs.

• Strong UX/UI design sensibility for building intuitive reporting tools for non‑technical users.

• Excellent stakeholder management, communication, and presentation skills.

• Strong analytical thinking and problem‑solving capabilities.

• Ability to work optimally in a fast‑paced, matrixed, and multi‑functional environment.

To Be Considered For This Role, You Must Have:

• 8+ years of experience in Clinical Data Management or clinical trial operations.

• Minimum 3+ years focused on clinical data reporting, analytics, or reporting tool development.

• Experience with clinical reporting applications, dashboards, and data visualization tools.

• Bachelors or Masters degree in Computer Science, Data Science, Bioinformatics, or a related field.

• Advanced degree (MBA/MS) preferred.

Equal Opportunity Employer

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (medical, dental, vision, life and disability), paid time off, and family support benefits.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.