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.

• Provide timely and effective updates regarding trial progress.

• Conduct client calls with proficiency.

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

• Take part in the planning and execution of the Investigator’s Meeting.

• Ensure that each site is equipped with necessary study materials, including investigational products, supplies, special equipment, and safety lab kits.

• Maintain audit readiness for assigned studies.

• Oversee the quality of study deliverables, including those from vendors and SubCROs, and address any issues that arise.

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

• Analyze differences between planned outcomes and actual results.

• Review and approve responses to quality assurance audits.

• Control project budgets, including the allocation of internal hours to various activities.

• Identify out-of-scope activities that may necessitate change orders.

• Manage 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.

• Track 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 that team members receive adequate training on the project.

• Collaborate with teams including Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, and Scientific Affairs to deliver results on time and in accordance with relevant standards.

⛳️ Requirements

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

• PMP or PRINCE2 certification is a plus.

• A minimum of 10 years of industry experience, including at least 3 years in a CRO.

• At least 7 years of experience in clinical project management, overseeing all project phases from initiation to closure, as well as all functional services and vendor management.

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

• Proven experience leading multicentered, multinational Phase III clinical trials, including tracking and forecasting project budgets.

• 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 an asset.

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

• Proficient in Microsoft Office suite.

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

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

• Ability to collaborate effectively within a team and build strong relationships with colleagues and sponsors.

• Strong problem-solving skills.

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

🏝️ Benefits

• Flexible schedule.

• Vacation.

• Home-based position.

• Ongoing learning and development opportunities.

• Attractive opportunities for growth and advancement.