Senior Project Manager – Dermatology/Rheumatology

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

📋 Description

• Act as the main point of contact for the Sponsor

• Deliver prompt and effective updates regarding trial progress

• Conduct client calls with efficiency

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

• Contribute to the planning and execution of the Investigator’s Meeting

• Ensure that each site is equipped with the necessary materials to conduct the study, such as investigational products, study supplies, specialized 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 guarantee project quality

• Assess discrepancies between projected and actual results

• Review and authorize responses to quality assurance audits

• Manage project budgets, particularly regarding internal hours assigned to activities

• Identify out-of-scope activities for change orders

• Oversee trial timelines, budgets, resources, and vendor relationships

• Coordinate tasks and deliverables across all functional departments

• Facilitate communication among study team members, functional departments, and senior management

• Report on recruitment status and pinpoint initiatives necessary to adhere to recruitment timelines

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

• Ensure team members receive sufficient training related to the project

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

⛳️ Requirements

• Minimum of 7 years of global clinical project management experience, encompassing all project phases from start-up to closure, along with vendor management

• At least 10 years of experience in the industry, including a minimum of 3 years within a CRO

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

• Experience leading multicentered, multinational Phase III clinical trials, including financial tracking and forecasting for project budgets

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

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

• Proficient in Microsoft Office Suite

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

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

• Strong problem-solving capabilities

• Proven ability to manage multiple projects and work under pressure while meeting deadlines

• 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 in managing trials related to dermatology, onco-dermatology, rheumatoid arthritis, or oncology is beneficial

• Bilingualism in English and the local language is a plus

🏝️ Benefits

• Comprehensive advancement opportunities

• Engaging work environment

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

• Commitment to equal opportunity and equitable treatment