Project Manager - Dermatology/Rheumatology (Spain)

Category: Project Management

Responsibilities

• Serve as primary contact for the Sponsor.
• Provide efficient and timely updates on trial progress.
• Lead client calls effectively.
• Oversee and actively participate in the preparation of project deliverables such as study plans, protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), and 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.).
• 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, and Project Assistants.
• Ensure all team members have adequate training on the project.
• Work closely with vendors and 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, and Scientific Affairs.

Requirements

• B.Sc. in a relevant discipline.
• At least 5 years of industry experience, including a minimum of 3 years leading multi-center clinical trials (phase II-III).
• Experience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD.
• Experience managing dermatology trials.
• Excellent knowledge of GCP and ICH standards, FDA, and local country regulations.
• Excellent knowledge of Microsoft Office suite.
• Fluency in English with excellent oral and written skills.
• Ability to work in a team environment and establish good relationships with colleagues and sponsors.
• Good problem-solving abilities.
• Strong ability to carry out different projects and work under pressure while meeting timelines.
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
• Ability to legally work in Spain.

Preferred Qualifications (Nice to Have)

• Experience managing rheumatology trials.

About the Company

Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Benefits

• Flexible work schedule.
• Permanent full-time position.
• Company benefits package.
• Ongoing learning and development.