Senior Project Manager – Dermatology/Rheumatology

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

📋 Description

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

• Provide timely and effective updates regarding trial progress.

• Lead client calls to facilitate communication.

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

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

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

• Maintain audit readiness for assigned studies at all times.

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

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

• Analyze discrepancies between planned and actual results.

• Review and approve responses to quality assurance audits.

• Oversee project budgets and internal hours allocated to various activities.

• Identify out-of-scope activities for change orders.

• Manage clinical trial timelines, budgets, resources, and vendor relationships.

• Coordinate tasks and deliverables among functional departments.

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

• Manage and report on recruitment status while highlighting initiatives needed to meet recruitment timelines.

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

• Ensure that team members receive sufficient project training.

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

⛳️ Requirements

• A minimum of 7 years of global clinical project management experience, covering all project phases from initiation to closure, including management of all functional services and vendor oversight.

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

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

• Experience leading multicenter, multinational Phase III clinical trials, specifically with project budget financial tracking and forecasting.

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

• PMP or PRINCE2 certification is considered an asset.

• Familiarity with 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 beneficial.

• Comprehensive understanding of GCP and ICH standards, along with local country regulations.

• Proficient in Microsoft Office suite.

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

• Bilingualism (English and local language) is an asset.

• Ability to work collaboratively in a team environment and build strong relationships with colleagues and sponsors.

• Strong problem-solving skills.

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

🏝️ Benefits

• Flexible working hours.

• Vacation time.

• Home-based work opportunity.

• Continuous learning and development opportunities.

• Dynamic work environment.

• Potential for growth and career advancement.