Project Manager II

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

📋 Description

• Assume full responsibility for the successful initiation, planning, execution, monitoring, controlling, and closure of assigned clinical trials.

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

• Serve as the primary communication link to relevant stakeholders.

• Contribute to feasibility assessments, study design, and budget formulation, while ensuring progress reporting on resources, budget, and timeline.

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

• Lead client conference calls.

• Oversee and actively engage in the preparation of study plans, protocols, informed consent forms, eCRFs, TLFs, and clinical study reports.

• Participate in the planning and execution of Investigator Meetings.

• Ensure that sites are supplied with the necessary investigational products, study materials, equipment, and safety lab kits.

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

• Collaborate with Regulatory Affairs on submissions and essential documentation.

• Work in partnership with Data Management on CRF alignment, data review, query resolution, and database lock timelines.

• Maintain audit readiness for studies and monitor the quality of deliverables from study, vendor, and SubCRO.

• Manage risks and implement quality-control measures; analyze planned versus actual results.

• Review and approve responses to quality assurance audits.

• Control project budgets and internal hours; identify out-of-scope activities for change orders.

• Oversee clinical trial timelines, budgets, resources, and vendors while coordinating cross-functional tasks and deliverables.

• Communicate effectively with study teams, functional departments, and senior management.

• Manage and report on recruitment status and initiatives.

• Lead the core project team and ensure project training is conducted.

• Coordinate with Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, and Scientific Affairs.

• Maintain project-specific training matrices and keep training records up to date.

⛳️ Requirements

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

• A minimum of 5 years of industry experience.

• At least 3 years of experience in Phase I-III clinical trial project management.

• Experience in managing dermatology and/or rheumatology trials.

• Proven track record of leading concurrent multi-center 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 oral and written communication skills in English; proficiency in French is a plus.

• Outstanding communication abilities.

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

• Strong problem-solving skills.

• Good organizational capabilities.

• Exceptional ability to manage multiple projects and work under pressure while adhering to timelines.

• Candidates must be legally authorized to work in Argentina.

🏝️ Benefits

• Flexible work schedule.

• Remote work opportunity.

• Continuous learning and development.

• Attractive opportunities for advancement.

• Commitment to equitable treatment and equal opportunity.

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