Senior Project Manager – Dermatology/Rheumatology

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

📋 Description

• Act as the main point of contact for the Sponsor.

• Provide timely and efficient updates regarding trial progress.

• Facilitate client calls.

• Supervise and actively engage in the preparation 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 supplied with necessary study materials, including investigational products, study supplies, special equipment, and safety lab kits.

• Maintain assigned studies in an audit-ready state.

• Oversee the quality of study and vendor/SubCRO deliverables and resolve issues as they arise.

• Manage risks and implement control measures to assure project quality.

• Evaluate discrepancies between planned and actual outcomes.

• Review and endorse responses to quality assurance audits.

• Oversee project budgets and the internal hours assigned to various activities.

• Identify activities that fall outside the project scope for change orders.

• Handle trial timelines, budgets, resources, and vendor relationships.

• Coordinate tasks and deliverables across different functional departments.

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

• Manage and report on recruitment status while identifying initiatives necessary to meet recruitment deadlines.

• Lead the core project team, including Associate Project Managers, Project Coordinators, and Project Assistants.

• Ensure that project team members receive proper training.

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

⛳️ Requirements

• A minimum of 7 years of global clinical project management experience, covering all project phases from start-up to closure, encompassing all functional services and vendor management.

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

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

• Demonstrated experience leading multicenter, multinational Phase III clinical trials, including financial tracking and forecasting for project budgets.

• A B.Sc. in a field related to clinical research.

• PMP or PRINCE2 certification is preferred.

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

• Therapeutic experience in managing trials related to dermatology, onco-dermatology, rheumatoid arthritis, or oncology is a plus.

• In-depth knowledge of GCP and ICH standards as well as local country regulations.

• Proficient in the Microsoft Office suite.

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

• Bilingualism in English and the local language is an advantage.

• Ability to thrive in a team-oriented environment and build strong relationships with colleagues and sponsors.

• Strong problem-solving skills.

• Capable of managing multiple projects and working under pressure while adhering to timelines.

🏝️ Benefits

• Flexible work schedule.

• Vacation time.

• Home-based working arrangement.

• Continuous learning and development opportunities.

• Attractive prospects for growth and advancement.