Project Manager II

Job not on LinkedIn

🔥 0 minutes ago

🇷🇴 Romania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 12%

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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

• Take overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials • Oversee and coordinate study resources to ensure compliance with study budget, project scope, timelines, SOPs, GCP, regulatory and study-specific requirements • Act as the main line of communication to 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 • Oversee and actively participate in preparation of study plans, protocols, informed consent forms, eCRFs, TLFs and clinical study reports • Participate in planning and conduct of Investigator’s Meetings • Ensure sites have required materials, investigational products, supplies, equipment and safety lab kits • 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 • Keep studies audit ready and monitor study deliverable quality • Manage risks, control measures, discrepancies and audit responses • Control project budgets and identify out-of-scope activities for change orders • Manage trial timelines, budgets, resources, vendors, recruitment status and cross-functional deliverables • Communicate with study teams, functional departments and senior management • Lead the core project team and ensure adequate project training • Coordinate with Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics and Scientific Affairs • Maintain project-specific training matrices and current 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 • 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 • Legally authorized to work in Romania

🏖️ Benefits

• Permanent full-time position • Flexible schedule • Vacation • Home-based position • Ongoing learning and development • Attractive advancement opportunities • Recruitment and selection accommodations for applicants with disabilities, upon request