Global Study Manager II

This is a fully remote position, open to applicants in Spain, +1 more country.

📋 Description

• Lead and guide the trial team, ensuring accountability for the successful execution and delivery of assigned clinical trials in accordance with established milestones and KPIs.

• Direct clinical trial operations, which encompass patient and site engagement activities.

• Engage and communicate directly with a variety of internal and external stakeholders and team members on a global scale, across multiple countries or regions.

• Develop trial timelines and evaluate operational feasibility.

• Supervise trial preparation to guarantee that trial team members are aligned and progressing as planned.

• Assist in the creation of trial-level documents managed by other departments, including Statistics, Data Management, Study Physician, Medical Writing, and Site Monitoring.

• Validate and contribute to country allocation and oversee trial feasibility assessments.

• Maintain supervision during trial execution, ensuring compliance with GCP, global and local regulatory standards, SOPs, and ongoing risk monitoring and mitigation.

• Aid in budget management, clinical quality oversight, SMC/DMC administration, and safety reporting.

• Prepare and enact amendments to core documents, including updates to training materials and retraining processes.

• Assist with responses to inquiries from regulatory authorities and ethics committees.

• Ensure timely cleaning and submission of clinical trial data.

• Coordinate and assist the trial medical writer in the preparation of the clinical trial report.

• Guarantee the prompt, complete, and compliant archiving of pertinent global documents in the TMF, including vendor documentation.

• Aid in the disclosure of results and documentation for global registries.

⛳️ Requirements

• Bachelor’s degree.

• At least 6 years of relevant experience in global study management and leadership.

• Proven experience in overseeing CROs and vendor relationships.

• Experience in managing per-subject costs, vendor and ancillary expenses, and monitoring budget projections and expenditures.

• Proficiency in written and spoken English is essential.

• Willingness to work outside of standard business hours as necessary to support global trials or initiatives.

• Ability to travel as needed, including for IMs, vendor kick-off and reset meetings, and client internal global or departmental meetings.

• Technical expertise in trial management systems and MS applications, such as Teams, MS Office, Project, CTMS, EDC, and IWRS/IVRS.

• Familiarity with ICH GCP and pertinent regulatory guidelines/directives.

• Strong interpersonal and leadership abilities.

• Capability to comprehend and implement strategic direction and guidance for specific clinical studies.

• Proficient verbal, written, and presentation communication skills.

🏝️ Benefits

• Temporary position lasting until April 2027.

• 100% remote work opportunity.

• Flexibility to work outside core business hours as necessary to support global trials or initiatives.

• Travel opportunities as required, including for IMs, vendor kick-off and reset meetings, and internal client global or departmental meetings.