Project Manager II, Dermatology and Rheumatology

Job not on LinkedIn

🔥 17 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Innovaderm Research Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 Description

• Oversee the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials • Coordinate study resources to ensure compliance with budgets, project scope, timelines, SOPs, GCP, regulatory and study-specific requirements • Act as the main line of communication for relevant stakeholders • Provide input to feasibility, study design and budget development, and ensure progress reporting • Serve as primary contact for the Sponsor and provide timely trial-progress updates • Lead client calls • Prepare and oversee project deliverables, including study plans, protocols, informed consent forms, eCRFs, TLFs and clinical study reports • Participate in Investigator’s Meetings • Ensure sites have required materials and equipment to perform studies • Lead study start-up activities, including trial kick-off, TMF setup, site selection and activation, vendor setup, contracting and budgeting • Collaborate with Regulatory Affairs on submissions and essential documents • Partner with Data Management on CRF alignment, data review, query resolution and database lock timelines • Maintain studies in an audit-ready state and monitor study and vendor deliverable quality • Manage risks, control measures, discrepancies, audit responses, project budgets, timelines, resources and vendors • Identify out-of-scope activities for change orders • Coordinate functional department tasks and deliverables • Report recruitment status and initiatives needed to meet recruitment timelines • Lead the core project team and ensure project training • Collaborate with vendors and internal teams including Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics and Scientific Affairs • Maintain the project-specific training matrix and training records

🎯 Requirements

• B.Sc. in a related field of study to clinical research • At least 5 years industry experience • 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 • 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 • Must be legally authorized to work in the United States

🏖️ Benefits

• Flexible work schedule / work schedule • Home-based position • Ongoing learning and development • Attractive advancement opportunities • Equal opportunity and accommodations throughout the recruitment and selection process, upon request