
Senior Project Manager β Dermatology/Rheumatology
Posted Aug 21

Posted Aug 21
This is a fully remote position, open to applicants in Spain.
β’ Act as the main point of contact for the Sponsor
β’ Deliver timely and efficient updates regarding trial progress
β’ Facilitate client calls
β’ Prepare and manage project deliverables, which include study plans, protocols, informed consent forms, eCRFs, TLFs, and clinical study reports
β’ Take part in the planning and execution of Investigator Meetings
β’ Ensure that each site has the necessary materials to conduct the study, including investigational products, study supplies, special equipment, and safety lab kits
β’ Maintain assigned studies in a state of readiness for audits at all times
β’ Oversee the quality of study, vendor, and SubCRO deliverables and resolve any issues
β’ Manage risks and implement control measures to ensure project quality
β’ Evaluate discrepancies between planned and actual outcomes
β’ Review and approve responses to quality assurance audits
β’ Manage project budgets, including the internal hours dedicated to activities
β’ Identify activities that fall outside the scope for change orders
β’ Oversee trial timelines, budgets, resources, and vendor relationships
β’ Coordinate tasks and deliverables across various functional departments
β’ Communicate effectively with study team members, functional departments, and senior management
β’ Manage and report on recruitment status and identify initiatives to meet recruitment timelines
β’ Lead the core project team, comprising Associate Project Managers, Project Coordinators, and Project Assistants
β’ Ensure team members receive sufficient training on the project
β’ Collaborate with Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, and Scientific Affairs teams, along with vendors
β’ Minimum of 7 years of global clinical project management experience, encompassing all project phases from initiation to closure, along with functional services and vendor management
β’ At least 10 years of industry experience, including no less than 3 years in a CRO
β’ Proven experience with mid-size and large studies (>10-15 countries) across multiple regions (NA, SA, APAC, MENA, Europe)
β’ Demonstrated experience in leading multicentered, multinational Phase III clinical trials, including project budget tracking and forecasting
β’ Bachelor's degree in a related field pertaining to clinical research
β’ In-depth knowledge of GCP and ICH standards as well as local country regulations
β’ Proficient in Microsoft Office suite
β’ Fluent in English with exceptional oral and written communication skills
β’ PMP or PRINCE2 certification is a plus
β’ Experience in study start-up, regulatory submission, resource management, supervisory roles, CRA, data management, medical writing, or vendor management is advantageous
β’ Therapeutic experience in managing trials related to dermatology, onco-dermatology, rheumatoid arthritis, or oncology is a benefit
β’ Bilingualism in English and the local language is a plus
β’ Ability to thrive in a team environment and build strong relationships with colleagues and sponsors
β’ Strong problem-solving skills
β’ Proven ability to manage multiple projects and perform well under pressure while meeting deadlines
β’ Must be legally authorized to work in Spain
β’ Flexible work schedule
β’ Permanent full-time position
β’ Comprehensive company benefits package
β’ Opportunities for ongoing learning and development
β’ Attractive prospects for career advancement
β’ Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request
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