Project Manager II, dermatology and rheumatology CRO,USA

Indero; United States; Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Flexible work schedule

Home-based position

Ongoing learning and development

Job summary

Indero is a Montreal-based CRO focused on dermatology and rheumatology trials. The Project Manager II drives initiation, planning, execution, monitoring, and closure of multicenter studies, coordinating resources to meet budget, scope and timelines.

You will lead client calls, plan study deliverables, oversee site activation, TMF setup, and collaboration with Regulatory Affairs and Data Management to ensure timely submissions and data integrity.

Qualifications

• 5+ years in industry with a minimum of 3 years in Phase I-III clinical trial project management.
• Experience in dermatology and/or rheumatology trials.
• Budget management for multi-site trials increasing >$3M USD and leading concurrent trials.

Responsibilities

• Serve as primary sponsor contact and provide timely updates on trial progress.
• Oversee planning and deliverables: study plans, protocol, ICF, eCRF, TLFs, and clinical study report.

Skills

GCP/ICH knowledge

Regulatory knowledge

Microsoft Office

English skills

French an asset

Education

B.Sc. in clinical research related field

Tools

eCRF systems

Regulatory databases

Job description

The project manager II has the overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials. The project manager II oversees and coordinates study resources to ensure compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements. Project Manager II acts as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development and ensures progress reporting (resources, budget and timeline)This role will be perfect for you if:You want to work for a mid-sized CRO that works on significant multisite trials, including Global Phase III projectsYou are looking to position yourself in an environment where you can grow your career alongside the companyIMPACT AND RESPONSIBILITIESClient interactionsServe as primary contact for the SponsorProvide efficient and timely updates on trial progressLead client calls effectivelyProject planningOversee 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.Quality and risk managementEnsure 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.Project budget and timelinesControl 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.Project team leadershipLead 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.Requirements:EducationB.Sc. in a related field of study to clinical researchExperienceAt least 5 years industry experience and a minimum of 3 years in Phase I-III clinical trial project managementExperience managing dermatology and/or rheumatology trialsExperience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD.Experience managing dermatology trials an assetKnowledge and skillsExcellent knowledge of GCP and ICH standards, FDA and Canadian regulationsExcellent knowledge of Microsoft Office suiteExcellent oral and written skills in English, French is an assetExcellent communication skillsAbility to work in a team environment and establish good relationships with colleagues and sponsorsGood problem-solving abilitiesGood organizational skillsStrong ability to carry out different projects and work under pressure while meeting timelinesBrand name:InderoOur company:The work environmentAt 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.In this position, you will be eligible for the following perks:Flexible work schedule / work schedule :Home-based positionOngoing learning and developmentAbout InderoIndero 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.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.Indero only accepts applicants who can legally work in the United States.