Senior Project Manager - Dermatology/Rheumatology (USA)

Indero is a clinical research organization specializing in dermatology and rheumatology clinical trials. The Senior Project Manager will serve as the primary internal and external contact for global clinical trials, leading project planning, quality and risk management, budgets, timelines, vendors, and cross-functional teams. The role focuses on ensuring trial activities and deliverables are completed on time, within budget, and to the required standards.

Responsibilities:

• 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.)
• 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

Requirements:

• • Has at least 7 years of Global clinical project management experience (including but not limited to European regions), including management of all project's phases from start-up to closure, management of all functional services, vendor management
• • Wishes to work for a mid-sized CRO that works on significant multisite trials, including Global Phase III projects
• • Is looking to position themselves in an environment where you can grow your career alongside of a growing company
• • B.Sc. in a related field of study to clinical research
• • At least 10 years industry experience including a minimum of 3 years in a CRO
• • At least 7 years of clinical project management experience, including management of all projects phases from start up to closure, management of all functional services, vendor management. Experience with mid-size and large studies (>10-15 countries) in multiple regions (NA, SA, APAC, MENA, Europe)
• • Experience leading multi-centered, multinational phase III clinical trials including project budget financial tracking and forecasting
• • Excellent knowledge of GCP and ICH standards, local country regulations
• • Excellent knowledge of Microsoft Office suite
• • Fluency in English with excellent oral and written skills, required
• • 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
• • PMP or PRINCE2 certification is an asset
• • Experience in one or more of the following considered an asset: study start up, regulatory submission, resource management, supervisory experience, CRA, data management, medical writing, or vendor management
• • Therapeutic experience managing dermatology, onco-dermatology, rheumatoid arthritis or oncology trials an asset
• • Bilingualism (English and local language) is an asset