Project Manager

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

📋 Description

• Ensure the effective initiation, planning, execution, monitoring, control, and closure of designated clinical research projects.

• Guarantee adherence to study budgets, project scope, timelines, standard operating procedures (SOPs), good clinical practices, regulatory guidelines, and study-specific needs.

• Act as the main point of contact for sponsors, vendors, and internal teams throughout the duration of studies.

• Coordinate tasks and deadlines across various departments.

• Supervise project coordinators, SSU team members, RDA, and RAC resources while prioritizing activities for site activation.

• Manage vendor supplies and services in alignment with site activation timelines.

• Alert the Project Manager II regarding site activation risks.

• Assist in managing the needs and expectations of sponsors and stakeholders.

• Support team training initiatives and plan project activities and resources accordingly.

• Ensure the quality of assigned tasks and deliverables.

• Provide regular project status updates to both internal and external stakeholders.

• Reconcile study trackers and assess planned versus actual discrepancies.

• Engage in corrective actions, change control, and risk management efforts.

• Review and contribute to the drafting of project operational plans, processes, and manuals.

• Ensure that study documents and deliverables comply with country-specific requirements.

• Oversee the planning of site feasibility, selection, and qualification visits.

• Monitor patient recruitment and the strategies for site recruitment.

• Participate in Investigator’s Meetings.

• Supervise central ethics and regulatory submissions in collaboration with Regulatory Affairs.

• Collect and maintain essential site documents throughout the studies.

• Assist with TMF quality reviews and audits to ensure inspection readiness.

• Support clinical monitoring activities, including CRA training, review of visit reports, site letters, and the resolution of escalated site issues.

• Track site visits, project training, monitoring reports, follow-up letters, and escalations of site issues.

• Maintain a project-specific training matrix and confirm team training completion.

• Ensure that sites are equipped with necessary materials, investigational products, supplies, equipment, and safety lab kits.

• Collaborate with Data Management to ensure CRF compliance, query resolution, and data review leading up to database lock.

• Provide technical, therapeutic, and project management expertise for training and departmental process improvements.

⛳️ Requirements

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

• A minimum of 3 years of experience in a comparable role, including responsibilities related to the management of clinical studies in the pharmaceutical, biotechnology, and/or CRO sectors.

• At least 2 years of experience coordinating activities related to clinical trial management.

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

• Proficient in the Microsoft Office suite.

• Strong oral and written communication skills in English.

• Proficiency in French is considered an asset.

• Exceptional communication abilities.

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

• Solid problem-solving skills.

• Well-developed organizational skills.

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

• Experience in managing small to medium-sized projects utilizing a structured approach to project management.

• Proven ability to establish and deliver resource-based project plans.

• Outstanding people management skills; experience working with and supervising teams in a matrix environment.

• Must have legal authorization to work in Argentina.

🏝️ Benefits

• Flexible work schedule.

• Home-based position.

• Continuous learning and development opportunities.

• Attractive prospects for career advancement.

• Recruitment and selection accommodations available for applicants with disabilities, upon request.