03 ago
|
Novartis
|
Baja California Sur
03 ago
Novartis
Baja California Sur
Job Description Summary
LI-Hybrid
Location: Mexico City, Mexico
This role is based in Mexico City, Mexico. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you.
We are hiring for 3 HEOR Operational Study Managers who will be accountable for the end‑to‑end operational execution and management of assigned US Medical Affairs non‑interventional studies, including retrospective analyses, prospective observational studies, Phase IV studies, Research Collaborations (RCs), and associated projects conducted on behalf of US MA HEOR.
This role supports US study teams by ensuring the planning, implementation, maintenance and closeout of all operational aspects, from concept through final report/manuscript, in compliance with timelines, budget, quality standards, and applicable regulations (GCP, SOPs, Work Practices).
The Operational Study Lead works closely with US MA HEOR leads, Evidence Generation Program Excellence, internal cross functional colleagues, and third‑party vendors to ensure consistent,
high‑quality study delivery and effective risk, quality, and vendor performance management.
Job Description
Key Responsibilities:
- Accountable for operational execution and management of assigned US MA HEOR non interventional studies (including RCs and Phase IV) and associated projects as applicable.
- Support HEOR teams for operational and administrative tasks related to all study phases, from concept development to final report/manuscript.
- Coordinate and facilitate the flow of the administrative processes for development and review of study protocols, Informed Consent Forms (ICFs), Institutional Review Board (IRB) submissions (as applicable), and related data plans (i.e. data management and data monitoring plans).
- Coordinate study concepts through submission, review and approval process, partnering with HEOR Leads and Medical Review Committee (MRC) Leads; facilitate tracking and reporting of timelines,
📌 HEOR Operational Study Manager (Baja California Sur)
🏢 Novartis
📍 Baja California Sur