Senior Project Manager – Dermatology/Rheumatology

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

📋 Description

• Act as the main point of contact for the Sponsor

• Deliver prompt and effective updates regarding trial progress

• Facilitate client calls

• Supervise and actively engage in the development of study plans, protocols, informed consent forms, eCRFs, TLFs, and clinical study reports

• Take part in the planning and execution of Investigator Meetings

• Ensure that sites are equipped with necessary study materials, investigational products, supplies, equipment, and safety lab kits

• Maintain assigned studies in an audit-ready state

• Oversee study deliverables, including those from vendors and SubCROs, and proactively address any issues

• Manage risks and implement control measures to ensure project quality

• Analyze variances between planned and actual results

• Review and authorize responses to quality assurance audits

• Oversee project budgets and manage internal hours allocated to activities

• Identify out-of-scope activities that require change orders

• Direct trial timelines, budgets, resources, and vendor relationships

• Coordinate tasks and deliverables across various functional departments

• Communicate with study team members, functional departments, and senior management

• Manage and report on recruitment status, identifying initiatives necessary to meet recruitment timelines

• Lead the core project team, which includes Associate Project Managers, Project Coordinators, and Project Assistants

• Ensure project team members receive comprehensive training

• Collaborate with vendors and internal teams in Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, and Scientific Affairs

⛳️ Requirements

• Minimum of 7 years of global clinical project management experience, overseeing all project phases from initiation to closure, including all functional services and vendor management

• At least 10 years of industry experience, with a minimum of 3 years spent in a CRO

• Proven experience with mid-size and large studies (>10–15 countries) across multiple regions (NA, SA, APAC, MENA, Europe)

• Experience in leading multicenter, multinational Phase III clinical trials, including project budget management and forecasting

• Bachelor's degree in a discipline related to clinical research

• PMP or PRINCE2 certification is a plus

• Background in study start-up, regulatory submission, resource management, supervisory roles, CRA, data management, medical writing, or vendor management is advantageous

• Therapeutic experience in managing dermatology, onco-dermatology, rheumatoid arthritis, or oncology trials is beneficial

• Strong understanding of GCP and ICH standards, as well as local country regulations

• Proficient in Microsoft Office suite

• Fluency in English with exceptional oral and written communication skills is essential

• Bilingualism in English and the local language is a bonus

• Ability to thrive in a team environment and build positive relationships with colleagues and sponsors

• Strong problem-solving skills

• Capacity to manage multiple projects and work under pressure while adhering to deadlines

🏝️ Benefits

• Flexible schedule

• Vacation

• Home-based position

• Continuous learning and development opportunities

• Engaging work environment

• Opportunities for growth and advancement