Study Manager, Global Study Management

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

📋 Description

• The Study Manager (SM) plays a crucial role within the Global Study Team, ensuring the timely, cost-effective, and high-quality delivery of clinical studies while maintaining inspection readiness through oversight of the study eTMF completeness.

• The SM collaborates closely with the Study Delivery Lead (SDL) on comprehensive operational study delivery activities, spanning from study initiation to archiving.

• The SM is accountable for monitoring the execution and advancement of the study, identifying, addressing, and escalating any risks or issues that may affect the study's quality, timeline, and budget targets.

• The SM reviews essential clinical documents, including the Protocol and Informed Consent Forms, and leads the creation of study plans for both internal and external purposes within the assigned studies.

• The SM facilitates and sustains interactions and meetings with both internal and external partners to guarantee the successful completion of assigned studies.

• The SM manages vendors and oversees CRO activities, serving as the primary contact point, supervising study-specific deliverables, and ensuring ongoing monitoring and timely completion of tasks delegated to third parties.

• The SM actively participates in teams, acting as a mediator by overcoming obstacles, enhancing team dynamics, fostering business agility, and embracing change.

⛳️ Requirements

• A university degree or equivalent, ideally in medical or biological science or a discipline related to clinical studies.

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

• Understanding of clinical trials and the drug development process.

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

• Familiarity with key systems utilized in the delivery of clinical trials.

• Experience with the industry-accepted standards for Trial Master Files.

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

• Exceptional verbal and written communication skills in English.

• Outstanding communication and relationship-building skills, including the ability to manage external service providers effectively.

🏝️ Benefits

• Flexible work arrangements

• Professional development