Senior Project Manager, Early Phase and Translational Research

Job not on LinkedIn

🔥 12 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 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.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 and manage domestic, regional and/or international clinical research projects • Develop and manage project teams, communications, risk, scope, schedule, cost, quality, and stakeholders • Ensure successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials • Act as the main line of communication to stakeholders • Provide input to feasibility, study design, budget development and progress reporting • Mentor and train other project managers and contribute to departmental continuous improvement • Serve as primary contact for sponsors, sites, CRAs, vendors and internal teams • Keep assigned studies audit ready, including training records, central files and system validation • Serve as escalation point for project issues and proactively resolve conflicts • Manage clinical trial timelines, budget, resources, vendors and cross-functional deliverables • Control project budgets, review billed time, and identify out-of-scope activities for change orders • Provide trial progress updates covering site and vendor selection, project plans, budgets, timelines, quality and risk mitigation • Develop and maintain project performance indicators and ensure KPIs remain within contract scope • Define project resource needs and establish succession plans • Lead study start-up, including kick-off meetings, TMF setup, site selection, site activation, vendor setup, contracting and budgeting • Manage risk and control measures to assure project quality • Lead client calls, internal work groups and vendor status meetings; ensure minutes are filed in the TMF • Monitor study deliverable quality and address quality issues • Analyze planned versus actual results and implement corrective actions • Maintain study-specific training matrices and review training records • Review and approve responses to quality assurance audits • Ensure study documents and deliverables are developed on time and meet requirements • Ensure project documentation is filed, maintained and archived in the TMF • Provide status updates in compliance with budgets, scope, timelines, SOPs, GCP, regulatory and study-specific requirements • Manage and report recruitment status and mitigation initiatives • Participate in Investigator’s Meetings • Collaborate with Regulatory Affairs on timely submissions and essential documents • Oversee clinical monitoring activities, including CRA training, monitoring reports, follow-up letters and site issue escalation • Contribute to the Clinical Monitoring Plan • Prepare and conduct CRA training and may perform single-site study initiation visits • Develop annotated site visit reports and monitoring tools • Support CRAs and Lead CRAs as a project contact • Support sites with investigational product, supplies, equipment and safety lab kits • Collaborate with data management on CRF compliance, query resolution and data review through database lock • Prepare and deliver presentations for new business • Provide technical, therapeutic and project management expertise in training and process improvement • Perform other assigned responsibilities when qualified and adequately trained

🎯 Requirements

• B.Sc. in a related field of study to clinical research • At least 7 years industry experience • Minimum of 5 years in Phase I-III clinical trial project management with financial accountability • Experience leading concurrent multi-centered, multinational clinical trials with budgets in excess of $25M USD • PMP certification desirable • Experience in cost management, study start up, regulatory submission, resource management, supervisory experience, CRA, data management, medical writing, or vendor management considered an asset • Therapeutic experience managing dermatology trials an asset • 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, required • Bilingualism (English and local language) is an asset • 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 • Must be legally able to work in the United States

🏖️ Benefits

• Stimulating work environment • Attractive advancement opportunities • Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request