Project Manager II, Dermatology and Rheumatology

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

📋 Description

• Manage the effective initiation, planning, execution, monitoring, controlling, and closure of assigned clinical trials.

• Coordinate study resources to ensure adherence to budgets, project scope, timelines, SOPs, GCP, regulatory, and study-specific requirements.

• Serve as the primary communication conduit for relevant stakeholders.

• Contribute to feasibility assessments, study design, and budget formulation, while ensuring progress reporting is maintained.

• Act as the main point of contact for the Sponsor, providing timely updates on trial progress.

• Lead client meetings and calls.

• Prepare and oversee project deliverables, such as study plans, protocols, informed consent forms, eCRFs, TLFs, and clinical study reports.

• Participate in Investigator’s Meetings.

• Ensure that sites have the necessary materials and equipment to conduct studies effectively.

• Drive study start-up activities, including trial kick-off, TMF setup, site selection and activation, vendor setup, contracting, and budgeting.

• Collaborate with Regulatory Affairs on submissions and essential documentation.

• Partner with Data Management for CRF alignment, data review, query resolution, and database lock timelines.

• Maintain studies in an audit-ready state and oversee the quality of study and vendor deliverables.

• Manage risks, control measures, discrepancies, audit responses, project budgets, timelines, resources, and vendors.

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

• Coordinate tasks and deliverables across functional departments.

• Report on recruitment status and initiatives required to meet recruitment timelines.

• Lead the core project team and ensure appropriate project training.

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

• Maintain the project-specific training matrix and training documentation.

⛳️ Requirements

• Bachelor of Science in a relevant field related to clinical research.

• Minimum of 5 years of experience in the industry.

• At least 3 years of experience in managing Phase I-III clinical trial projects.

• Experience in managing dermatology and/or rheumatology trials.

• Proven track record of leading concurrent multi-centered clinical trials with budgets exceeding $3M USD.

• Strong knowledge of GCP and ICH standards, as well as FDA and Canadian regulations.

• Proficient in Microsoft Office Suite.

• Excellent verbal and written communication skills in English; proficiency in French is a plus.

• Exceptional communication abilities.

• Capability to work in a team-oriented environment and build strong relationships with colleagues and sponsors.

• Strong problem-solving skills.

• Good organizational skills.

• Ability to manage multiple projects and work under pressure while meeting deadlines.

• Must be legally authorized to work in the United States.

🏝️ Benefits

• Flexible work schedule.

• Home-based position.

• Continuous learning and development opportunities.

• Attractive opportunities for advancement.

• Equal opportunity and accommodations throughout the recruitment and selection process, upon request.