Global Study Management Associate

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

📋 Description

• Assist the Global Clinical Study Manager in the worldwide delivery and execution of assigned clinical study components while adhering to quality, timelines, and budget constraints.

• Facilitate the alignment of study objectives with clinical operations goals.

• Organize and manage logistics for cross-functional Clinical Study Team meetings.

• Collaborate with the Global Clinical Study Manager, Regional Clinical Trial Management Associates, and both global and regional stakeholders.

• Create and maintain study-specific SharePoint resources and Clinical Study Team distribution lists.

• Set up studies in systems like eTMF and CTMS, ensuring study information is up-to-date.

• Oversee study-system access and user accounts throughout the lifecycle of the study.

• Assist in the development of study plans and the organization of investigator meetings.

• Support site feasibility assessments.

• Monitor study deliverables including screening, enrollment, biological samples, images, data flow, and protocol deviations.

• Compile management metrics and updates.

• Aid in the creation of study newsletters and correspondence related to study conduct.

• Support the establishment, maintenance, document review, and quality control of the study-level TMF.

• Assist in study drug forecasts and supply chain activities.

• Contribute to data cleaning efforts and follow up on outstanding information.

• Aid in the planning and execution of Clinical Study Reports.

• Identify operational risks and issues, providing recommendations for resolution.

• Propose enhancements to improve efficiency and quality.

• Assist in the selection and setup of vendors for global outsourced activities.

• Support management of study budgets, including purchase-order setup and invoice tracking.

⛳️ Requirements

• A Bachelor’s degree or higher in a scientific or healthcare-related field is required; a higher degree is preferred.

• Exceptions may be considered for candidates with pertinent clinical operations experience.

• At least 1 year of experience in clinical research within the Biotech, Pharma, or CRO industry.

• Familiarity with clinical operations methodologies and a solid understanding of the operational facets of clinical study processes.

• Knowledge of clinical study operations, including the interpretation and implementation of regulatory and ICH-GCP guidelines.

• Proficiency in the MS Office Suite, particularly Excel, PowerPoint, and Project.

• Some travel may be required.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k).

• FSA/HSA.

• Life Insurance.

• Paid Time Off.

• Wellness programs.