Senior Project Manager – Dermatology/Rheumatology

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

📋 Description

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

• Deliver timely and effective updates regarding trial progress.

• Facilitate client conference calls.

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

• Take part in the planning and execution of Investigator Meetings.

• Ensure that sites are equipped with essential materials, including investigational products, study supplies, specialized equipment, and safety lab kits.

• Maintain audit readiness for all assigned studies at all times.

• Monitor study deliverables, including those from vendors and SubCROs, and address any arising issues.

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

• Analyze variances between planned and actual outcomes.

• Review and authorize responses to quality assurance audits.

• Oversee project budgets, which includes managing internal hours allocated to various activities.

• Identify out-of-scope activities for change order requests.

• Manage timelines, budgets, resources, and vendors associated with clinical trials.

• Coordinate tasks and deliverables across different functional departments.

• Maintain communication with study team members, functional departments, and senior management.

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

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

• Ensure that project team members receive appropriate 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 initiation to closure, along with functional services and vendor management.

• At least 10 years of industry experience, including a minimum of 3 years in a Contract Research Organization (CRO).

• Experience with mid-sized and large studies across more than 10–15 countries in multiple regions (NA, SA, APAC, MENA, Europe).

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

• Bachelor’s degree in a field relevant to clinical research.

• PMP or PRINCE2 certification is considered an asset.

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

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

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

• Proficient in the Microsoft Office suite.

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

• Bilingualism in English and the local language is a plus.

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

• Strong problem-solving skills.

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

🏝️ Benefits

• Flexible work schedule.

• Vacation time.

• Remote work opportunity.

• Continuous learning and development prospects.

• Engaging work environment.

• Opportunities for professional growth and advancement.