Project Manager II

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

📋 Description

• Take full responsibility for the effective initiation, planning, execution, monitoring, controlling, and closure of designated clinical trials.

• Supervise and coordinate study resources to ensure compliance with the study budget, project scope, timelines, SOPs, GCP, regulatory requirements, and study-specific guidelines.

• Serve as the primary communication link to all relevant stakeholders.

• Contribute to feasibility assessments, study design, and budget preparation, while ensuring progress reporting on resources, budget, and timelines.

• Act as the main contact for the Sponsor, providing timely updates on trial progress.

• Effectively lead client calls.

• Oversee and assist in the preparation of study plans, protocols, informed consent forms, eCRFs, TLFs, and clinical study reports.

• Participate in the planning and execution of Investigator’s Meetings.

• Ensure that sites are equipped with the necessary study materials and equipment.

• Lead trial initiation activities, including kick-off meetings, TMF setup, site selection and activation, vendor setup, contracting, and budgeting.

• Collaborate with Regulatory Affairs to ensure timely submissions and essential document management.

• Partner with Data Management for CRF alignment, data review, query resolution, and database lock timelines.

• Maintain audit readiness for assigned studies and monitor the quality of deliverables.

• Manage project risks and control measures, analyze planned versus actual outcomes, and review responses to quality assurance audits.

• Oversee project budgets and identify activities outside of the scope for change orders.

• Manage trial timelines, budgets, resources, vendors, recruitment status, and cross-functional deliverables.

• Communicate effectively with study teams, functional departments, and senior management.

• Lead the core project team and ensure comprehensive project training.

• Collaborate with Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, and Scientific Affairs.

• Maintain the project-specific training matrix and ensure current training records are up-to-date.

⛳️ Requirements

• Bachelor’s degree in a field related to clinical research.

• A minimum of 5 years of industry experience.

• At least 3 years of experience in project management for Phase I-III clinical trials.

• Experience in managing dermatology and/or rheumatology trials.

• Proven experience leading concurrent multi-center clinical trials with budgets exceeding $3M USD.

• Strong knowledge of GCP and ICH standards, as well as FDA and Canadian regulations.

• Proficiency in Microsoft Office Suite.

• Excellent oral and written communication skills in English.

• Ability to work collaboratively in a team environment and establish positive relationships with colleagues and sponsors.

• Strong problem-solving skills.

• Good organizational capabilities.

• Exceptional ability to manage multiple projects and work under pressure while meeting deadlines.

• Applicants must possess legal authorization to work in Spain.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Comprehensive company benefits package.

• Continuous learning and development opportunities.

• Attractive prospects for advancement.