Project Manager II (Argentina)

• You want to work for a mid-sized CRO that works on significant multisite trials, including Global Phase III projects
• You are looking to position yourself in an environment where you can grow your career alongside the company

• Serve as primary contact for the Sponsor
• Provide efficient and timely updates on trial progress
• Lead client calls effectively

• Oversee and actively participates in the preparation of project deliverables such as; study plans, protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report.
• Participate in the planning and conduct of the Investigator’s Meeting.
• Ensure that each site has the necessary material to adequately perform the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.).
• Lead study start-up activities including trial kick-off, TMF setup, site selection and activation, vendor set-up timelines, and site contracting and budgeting.
• Collaborate with Regulatory Affairs to ensure timely submissions and completeness of essential documents prior to site initiation and throughout the study.
• Partner with Data Management to ensure CRF alignment with protocol and sponsor requirements, and that data review, query resolution, and database lock timelines are met.

• Ensure assigned studies are “audit ready” at all times.
• Monitor the quality of study deliverables, (including vendor and SubCRO deliverables) and address issues as they arise.
• Manage risk and control measures to assure project quality.
• Analyze discrepancies between planned and actual results.
• Review and approve responses to quality assurance audits.

• Control the project budget, with particular attention to internal hours allocated to all activities.
• Identify out of scope activities for change orders.
• Proactively manage operational aspects of the clinical trial including trial timelines, budget, resources and vendors. Coordinate tasks and deliverables from all functional departments involved in the project.
• Communicate effectively with study team members, functional departments, and senior management.
• Manage and report on recruitment status and highlight initiatives needed to meet recruitment timelines.

• Lead the core project team which may include: Associate Project Managers, Project Coordinators, Project Assistants.
• Ensure all team members have adequate training on the project.
• Work closely with vendors and the following internal teams to ensure all tasks and deliverables are completed on time, according to plans and according to applicable standards: Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, Scientific Affairs.
• Define and maintain the project-specific training matrix and ensure training records are kept up to date throughout the study.

• Flexible work schedule / work schedule :
• Home-based position
• Ongoing learning and development

• B.Sc. in a related field of study to clinical research

• At least 5 years industry experience and a minimum of 3 years in Phase I-III clinical trial project management
• Experience managing dermatology and/or rheumatology trials
• Experience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD.
• Experience managing dermatology trials an asset

• Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations
• Excellent knowledge of Microsoft Office suite
• Excellent oral and written skills in English, French is an asset
• Excellent communication skills
• Ability to work in a team environment and establish good relationships with colleagues and sponsors
• Good problem-solving abilities
• Good organizational skills
• Strong ability to carry out different projects and work under pressure while meeting timelines

Indero