Senior Clinical Trial Manager

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

📋 Description

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

• Provide comprehensive study-level oversight and leadership from the initiation to the closure of trials.

• Facilitate cross-functional team leadership, stakeholder engagement, strategy formulation, meeting coordination, and documentation.

• Manage external vendors, including RFP processes, vendor selection, scopes of work, deliverables, and risk management strategies.

• Drive global recruitment strategies, feasibility assessments, subject recruitment, retention efforts, and risk mitigation planning.

• Lead meetings involving cross-functional teams, vendors, and investigators, while providing regular updates on study status.

• Ensure readiness for inspections and actively participate in related activities.

• Identify, mitigate, escalate, and manage risks associated with studies.

• Collaborate in the development and management of protocols, regulatory submissions, informed consent, study plans, budgets, agreements, clinical study reports, training materials, newsletters, and presentations.

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

• Support design reviews, user acceptance testing, and associated plans for EDC, IRT, and ePRO systems, as well as manage risk indicators, access support, and query resolution.

• Manage investigational products and study supplies effectively.

• Provide training to stakeholders.

• Assist in formulating global submission strategies.

• Contribute to process improvement initiatives and act as a subject matter expert or mentor.

⛳️ Requirements

• Bachelor's Degree or equivalent qualification from outside the U.S. is required.

• A minimum of 4 years of progressive experience in the pharmaceutical industry or clinical research.

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

• Experience with EDC, IRT, CTMS, and eTMF systems is essential.

• Strong analytical and critical thinking capabilities.

• 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 spoken and written.

• A proactive and collaborative approach is necessary.

• Capability to work independently within a fast-paced global team environment.

🏝️ Benefits

• Opportunity for remote work.

• Commitment to equal opportunity employment.

• An integrity-driven workplace culture.

• Focus on innovation in the workplace.

• Dedication to community service initiatives.