Senior Clinical Trial Manager

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

📋 Description

• Plan, execute, and oversee one or more Phase 0–4 global clinical trials

• Provide leadership and study-level oversight in a cross-functional setting from initiation to closure

• Assist in the strategic leadership of cross-functional teams by engaging and influencing stakeholders

• Create strategies, lead meetings, and ensure timely documentation at the study level

• Manage external vendors, including RFP processes, selection, scope of work, deliverables, and risk management

• Direct the global recruitment strategy, including feasibility assessments, subject recruitment, retention efforts, and mitigation planning

• Facilitate cross-functional, vendor, and investigator meetings; prepare agendas and organize meeting minutes

• Ensure readiness for inspections and engage in related activities

• Identify, mitigate, and manage risks, including reviewing issues, escalating concerns, and analyzing trends

• Co-develop and oversee protocols, regulatory submissions, patient-reported outcome measures, study execution plans, informed consent documents, site budgets and agreements, clinical study reports, training materials, newsletters, and presentations

• Manage CTMS and eTMF to ensure compliance, readiness for inspections, trend analysis, and adherence to timelines

• Support the design review of EDC, IRT, and ePRO, including user acceptance testing, plan development, risk indicators, access, query resolution, and system oversight

• Manage investigational products and related study supplies

• Provide training for stakeholders

• Assist in global submission strategies

• Support initiatives for process improvement or act as a subject matter expert and/or mentor

⛳️ Requirements

• Bachelor’s Degree or an equivalent qualification outside the U.S. is required

• A minimum of 4 years of progressive experience in Pharma-related or clinical research

• High level of core and technical competencies

• Proficient in standard quality procedures, including SOP, ICH/GCP, and Global Regulations

• Experienced in using EDC, IRT, CTMS, and eTMF

• Strong analytical and critical thinking abilities

• Excellent organizational and time management skills

• Keen attention to detail

• Exceptional interpersonal and communication abilities in a global context

• Proficient in business and technical English, both written and oral

• Proactive and collaborative approach

• Ability to work independently in a fast-paced global team environment

• Preferred: experience with study initiation through completion activities and exposure to global studies

🏝️ Benefits

• Equal opportunity employer

• Committed to operating with integrity, fostering innovation, transforming lives, and serving the community