Project Manager, Vendor Management – Early Phase

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

📋 Description

• Guarantee the successful initiation, planning, execution, monitoring, control, and closure of assigned clinical research projects.

• Supervise and manage study-specific vendors throughout the start-up, conduct, and closeout phases.

• Coordinate vendor scope, timelines, deliverables, budgets, performance, documentation, risks, issues, and escalations.

• Act as the primary liaison for Sponsors, vendors, and internal teams.

• Organize tasks and deadlines across various project departments.

• Oversee project coordinators, SSU team members, RDA, and RAC resources.

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

• Escalate risks to site activation timelines to Project Manager II.

• Address Sponsor and stakeholder needs and expectations.

• Facilitate team training and organize project activities and resources.

• Ensure the quality of assigned work and deliverables.

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

• Reconcile study trackers and evaluate planned versus actual results.

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

• Review and assist in drafting project operational plans, processes, and manuals.

• Confirm that study documents and deliverables comply with country requirements.

• Oversee site selection and qualification planning.

• Monitor patient recruitment and follow up with sites on recruitment strategies.

• Participate in Investigator's Meetings.

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

• Ensure the collection and maintenance of essential site documents.

• Support TMF quality reviews and audits to ensure inspection readiness.

• Assist clinical monitoring activities and keep track of site visits, training, monitoring reports, and site issues.

• Maintain the project-specific training matrix.

• Ensure sites have the necessary study materials and equipment.

• Support CRF compliance, query resolution, and data review up to database lock.

• Provide clinical, therapeutic, and project management expertise during training and process improvement initiatives.

• Oversee vendors to ensure services align with timelines, scope, quality, and budget.

• Serve as the main point of contact for assigned vendors.

• Review vendor work orders, budgets, and scopes of work; assist with change orders.

• Monitor vendor performance, deliverables, timelines, and milestones.

• Lead or participate in vendor meetings and document follow-up actions.

• Collaborate with subject matter experts to communicate study requirements.

• Review and approve vendor invoices.

• Manage vendor risks, issues, and deviations, implementing corrective actions as needed.

• Support vendor quality events, non-conformances, CAPAs, and performance improvement initiatives.

• Maintain comprehensive and updated vendor documentation in the TMF and other systems.

• Track vendor metrics and KPIs, providing updates to stakeholders.

• Foster positive vendor relationships while ensuring compliance with contractual and performance obligations.

⛳️ Requirements

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

• Minimum of 3 years of experience in a similar role, encompassing the management of clinical studies within the pharmaceutical, biotechnology, and/or CRO sectors.

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

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

• Proficiency in Microsoft Office Suite.

• Exceptional oral and written communication skills in English; proficiency in French is a plus.

• Strong communication abilities.

• Capability to work collaboratively in a team environment and cultivate positive relationships with colleagues and sponsors.

• Strong problem-solving skills.

• Effective organizational abilities.

• Robust capacity to manage multiple projects and perform under pressure while adhering to timelines.

• Experience managing small to medium projects using a structured approach to project management.

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

• Excellent people management skills; experience working with and leading teams in a matrix environment.

• Legally authorized to work in Argentina.

🏝️ Benefits

• Flexible working schedule.

• Vacation days.

• Home-based position.

• Opportunities for ongoing learning and development.

• Attractive prospects for career advancement.

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