Senior Project Manager – Dermatology/Rheumatology

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

📋 Description

• Act as the primary liaison for the Sponsor

• Deliver prompt and effective updates regarding trial progress

• Conduct client calls with professionalism

• 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 sites are equipped with necessary investigational products, study materials, 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 resolve any issues

• Manage risks and implement control measures to ensure project quality

• Analyze differences between planned and actual outcomes

• Review and authorize responses to quality assurance audits

• Monitor project budgets and manage internal hours allocated to activities

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

• 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 highlight initiatives required to meet timelines

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

• Ensure that project team members receive sufficient project training

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

⛳️ Requirements

• Bachelor's degree in a related field

• Minimum of 7 years of experience in the industry

• At least 5 years of experience leading multi-center clinical trials (phase II-III)

• Proven experience managing concurrent multi-centered clinical trials with budgets exceeding $3M USD

• Experience in managing dermatology trials

• Experience in managing rheumatology trials is a plus

• Comprehensive understanding of GCP and ICH standards, as well as FDA and local regulations

• Proficient in Microsoft Office suite

• Fluent in English with exceptional oral and written communication skills, required

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

• Effective problem-solving skills

• Strong capacity to manage multiple projects and perform under pressure while meeting deadlines

• Solid knowledge of good clinical practices and relevant Health Canada and FDA regulations/guidelines

• Legally permitted to work in Germany

🏝️ Benefits

• Engaging work environment

• Competitive opportunities for career advancement

• Accommodations available throughout the recruitment and selection process for applicants with disabilities, upon request