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Principal Study Data Manager

Synthorx

Synthorx

Data Science
Hyderabad, Telangana, India
Posted on Saturday, June 15, 2024

Job title: Principal Study Data Manager

  • Location: IN / Hyderabad

About the job

Within the Clinical Trial Team (CTT), the Principal Study Data Manager is responsible for leading the end-to-end Clinical Data Management (CDM) activities and study deliverables supporting study set-up, conduct and close-out, complying with GCP and applicable regulatory guidance.

Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As Principal Study Data Manager within our Clinical Data Management, you’ll will be accountable for the quality of CDM deliverables and for ensuring accurate and reliable study data, therefore guaranteeing the reliability of the study results. The employee ensures activities are completed according to agreed standards and timelines. The employee provides comprehensive CDM expertise and supports team members by coordinating cross functional data related activities globally to ensure the flawless conduct of a clinical trial.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Major Responsibilities:

  • Accountability for the quality of CDM deliverables (such as CRFs, CRF Completion Instructions, Centralized Monitoring Plan, Data Management Plan, Data Validation Specifications, Data Review Listings/Reports/Visualizations) and for the delivery of accurate and reliable clinical study data.

  • Liaising directly with internal customers (Global Study Manager, Study Medical Manager, Statistician, Central Monitors, Pharmacovigilance, Quality, etc.) to coordinate all CDM activities for studies, discussing timelines, and providing CDM updates.

  • Proactively anticipating and remediating CDM issues arising during study conduct and monitoring them until resolution.

  • Defining and implementing data cleaning & validation strategy integrating risk-based approaches.

  • Contributing to the protocol review, Study Risk Management Plan, SAE reconciliation, deviation review, data review, medical review, and other review activities during the conduct of a study.

  • Leading study activities with internal and external (e.g., Providers) CDM delivery teams (Database Developers, Data Management Programmers, Central Monitors, etc.) and mentoring new Study Data Managers.

  • Coordinating all external data activities: specifications, loading and reconciliation, including data collected through Central Labs, eCOA, IRT, connected devices, telemedicine, and mobile healthcare.

  • Identifications of areas for continuous improvement and active participation or leadership of transformation initiatives.

About you

  • Experience: Strong experience on clinical data management and must have been in a project management role.

  • Soft skills: Strong project management skills and experience. Anticipate delivery risks.

  • Learn and adapt quickly when facing new problems.

  • Good interpersonal, communication, and presentation skills.

  • Technical skills: Strong experience with CDM and related regulations (incl. ICH E6 and E8).

  • Solid risk-based mindset focusing on Quality by Design (QbD) and on what really matters.

  • Understanding of advanced drug development concepts such as Decentralized Clinical Trials (DCT), Master & Adaptive Protocols, eSource and AI Based automations is a plus

  • Education: Bachelor’s degree or above, preferably in a life science or drug development related field.

  • Languages: Strong English skills (verbal and written), ability to exchange fluently in a global environment.

Why choose us?

  • Bring the miracles of science to life alongside a supportive, future-focused team.

  • Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

  • Join an international innovative biopharma company.

  • Participate in the evolution of Clinical Data Management and deployment of innovations.

“Sanofi is at the forefront of the Clinical Data Management Modernization. Our ambitions are significant but pragmatic. The speed of change unprecedented but achievable. Join us of you want to help us transform our vision into a reality!”

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!