Study Manager – Global Study Management

This is a fully remote position, open to applicants in Mexico.

📋 Description

• The Study Manager (SM) plays a vital role within the Global Study Team, ensuring the successful delivery of clinical studies within the established time, budget, and quality parameters, while also maintaining inspection readiness through oversight of study eTMF completeness.

• The SM collaborates closely with the Study Delivery Lead (SDL) on all operational activities related to study delivery, from initial setup to final archival.

• The SM engages cross-functionally with both internal teams and external partners to manage clinical study activities as coordinated with the Study Delivery Lead.

• The SM is tasked with monitoring the conduct and progress of studies, proactively identifying, addressing, and escalating any risks or issues that may affect the study's delivery in terms of quality, timelines, and budget.

• The SM facilitates and maintains effective interactions and meetings with internal and external stakeholders to ensure the successful execution of assigned studies.

• The SM oversees data management to guarantee that the study remains inspection-ready at all times, including managing the completeness of the eTMF.

⛳️ Requirements

• A minimum of 3+ years of relevant experience in a pharmaceutical or scientific setting.

• Familiarity with clinical trials and the drug development process.

• In-depth understanding of ICH-GCP, the clinical study delivery process, including regulations, operational best practices, and industry standards.

• Well-versed in the key systems utilized in clinical trial delivery.

• Experience with the Trial Master File in accordance with industry-accepted standards.

• Strong project management abilities (preferably with analytical or financial skills) along with effective leadership capabilities.

• Proficient in verbal and written communication in English.

🏝️ Benefits

• Accessible disability services

• Professional development opportunities