Senior Project Manager – Dermatology/Rheumatology

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

📋 Description

• Act as the primary liaison for the Sponsor

• Deliver timely and efficient updates regarding trial progress

• Effectively lead client conference 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 each site is equipped with the necessary materials, investigational products, supplies, equipment, and safety lab kits

• Maintain audit readiness for assigned studies at all times

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

• Manage risks and implement control measures to ensure project quality

• Analyze variances between planned and actual results

• Review and authorize responses to quality assurance audits

• Manage project budgets, including oversight of internal hours allocated to activities

• Identify out-of-scope activities for change orders

• Proactively oversee trial timelines, budgets, resources, and vendor relationships

• Coordinate tasks and deliverables across various functional departments

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

• Manage and report on recruitment status and identify initiatives necessary to meet recruitment timelines

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

• Ensure that all team members receive appropriate project training

• Collaborate with Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, and Scientific Affairs teams, as well as vendors, to ensure timely completion of deliverables according to applicable standards

⛳️ Requirements

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

• At least 10 years of industry experience, including no less than 3 years in a Contract Research Organization (CRO)

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

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

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

• PMP or PRINCE2 certification is a plus

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

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

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

• Proficient in Microsoft Office Suite

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

• Bilingualism in English and the local language is an asset

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

• Strong problem-solving skills

• Ability to manage multiple projects and perform well under pressure while meeting deadlines

🏝️ Benefits

• Flexible working hours

• Vacation time

• Home-based position

• Continuous learning and development opportunities

• Attractive prospects for growth and advancement