Project Manager

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

📋 Description

• Ensure the successful initiation, planning, execution, monitoring, controlling, and closure of assigned clinical research projects.

• Ensure adherence to study budgets, project scopes, timelines, SOPs, good clinical practices, regulatory standards, and study-specific requirements.

• Act as the primary point of contact for sponsors, vendors, and internal teams throughout the study lifecycle.

• Coordinate tasks and deadlines across various departments involved in the project.

• Supervise project coordinators, SSU team members, RDA, and RAC resources, prioritizing site activation activities.

• Manage vendor supplies and services in alignment with site activation timelines.

• Escalate any at-risk site activation timelines to the Project Manager II.

• Assist in managing the needs and expectations of sponsors and stakeholders.

• Aid in team training and planning of project activities and resources.

• Oversee the quality of assigned work and deliverables.

• Provide project status updates to both internal and external stakeholders.

• Reconcile study trackers and analyze discrepancies between planned and actual results.

• Engage in corrective actions, change control, and risk management processes.

• Review and assist in drafting project operational plans, processes, and manuals.

• Ensure that study documents and deliverables comply with applicable country requirements.

• Oversee site selection, feasibility questionnaires, and site qualification visit planning.

• Monitor patient recruitment and subject status; follow up with sites regarding recruitment strategies.

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

• Coordinate central ethics and regulatory submissions with Regulatory Affairs.

• Ensure the collection and maintenance of essential site documents.

• Assist with TMF quality reviews and audits to ensure inspection readiness.

• Support clinical monitoring activities, including CRA training, visit report reviews, site letters, and escalated site issues.

• Track site visits, project-specific training, monitoring reports, follow-up letters, and site issue escalations.

• Maintain the project-specific training matrix and confirm compliance with team training.

• Provide support to sites regarding investigational products, study supplies, equipment, and safety lab kits.

• Collaborate with Data Management on CRF compliance, query resolution, and data review leading up to database lock.

• Offer technical, therapeutic, and project management expertise for training and process improvement.

⛳️ Requirements

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

• Minimum of 3 years of experience in a similar role, including management of clinical studies within the pharmaceutical, biotechnology, and/or CRO industry.

• At least 2 years of experience coordinating activities related to clinical trial management.

• Comprehensive knowledge of GCP and ICH standards, along with FDA and Canadian regulations.

• Proficient in Microsoft Office suite.

• Exceptional oral and written communication skills in English; proficiency in French is a plus.

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

• Strong problem-solving capabilities.

• Excellent organizational skills.

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

• Experience in managing small to medium projects utilizing a structured approach to project management.

• Demonstrated capability to establish and deliver resource-based project plans.

• Outstanding people management skills; experience in leading and managing teams in a matrix environment.

• Must possess legal authorization to work in Spain.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Comprehensive company benefits package.

• Opportunities for ongoing learning and development.

• Attractive prospects for advancement.