Senior Project Manager – Dermatology/Rheumatology

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

📋 Description

• Act as the main point of contact for the Sponsor

• Deliver prompt and effective updates regarding trial progression

• Lead conference calls with clients

• Oversee and contribute significantly to the creation of study plans, protocols, informed consent forms, eCRFs, TLFs, and clinical study reports

• Engage in the planning and execution of Investigator Meetings

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

• Confirm that assigned studies are prepared for audits

• Monitor the quality of study, vendor, and SubCRO deliverables, addressing any arising issues

• Manage risks and implement control measures to ensure project quality

• Analyze differences between planned objectives and actual outcomes

• Review and approve responses to quality assurance audits

• Manage project budgets, including internal hours allocated to various activities

• Identify activities beyond the project scope for change orders

• Oversee 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 and initiatives necessary to meet recruitment timelines

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

• Ensure that project team members receive sufficient training

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

⛳️ Requirements

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

• At least 10 years of industry experience, including a minimum of 3 years within a CRO

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

• Proven experience leading multicenter, multinational Phase III clinical trials, with a focus on project budget financial tracking and forecasting

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

• PMP or PRINCE2 certification is advantageous

• Relevant experience in study start-up, regulatory submissions, resource management, supervisory roles, CRA, data management, medical writing, or vendor management is a plus

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

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

• Proficient in the Microsoft Office suite

• Fluency in English with excellent oral and written communication skills is mandatory

• Bilingualism (English and the local language) is a plus

• Ability to thrive in a team environment and foster strong relationships with colleagues and sponsors

• Strong problem-solving skills

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

🏝️ Benefits

• Flexible working hours

• Vacation time

• Remote work position

• Continuous learning and development opportunities

• Engaging work environment

• Opportunities for career growth and advancement