Project Manager II, Early Phase

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🔥 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

• Lead the initiation, planning, execution, monitoring, control, and closure of assigned Phase I and Phase II clinical trials • Act as the main point of contact for sponsors, vendors, and internal study teams throughout the clinical trial lifecycle • Coordinate study resources, deliverables, timelines, budgets, scope, vendors, and clinical operations across departments • Collaborate with clients during study start-up to determine effective operational approaches • Maintain communication with sponsors, study teams, functional departments, clinical sites, and senior management • Monitor study budgets, track hours, review billed time, identify out-of-scope activities, and support change order management • Provide regular project status updates covering site selection, vendor management, budgets, timelines, quality standards, and risk mitigation • Lead kick-off meetings, TMF setup, site selection and activation, vendor onboarding, site contracting, and budget negotiations • Identify and manage risks, implement quality controls, and escalate issues when necessary • Lead client, internal team, and vendor meetings and manage meeting documentation • Oversee project deliverables and drive continuous improvement in training, execution, and quality processes • Evaluate planned versus actual project outcomes and implement corrective actions • Maintain study-specific training matrices and verify project training records • Review and approve responses to quality assurance audits • Ensure protocols, informed consent forms, eCRFs, source document templates, TLFs, and clinical study reports are completed on schedule and meet requirements • Oversee filing, maintenance, and archiving of study documentation in the TMF • Track recruitment performance and develop mitigation plans for enrollment risks • Participate in Investigator Meetings • Work with Regulatory Affairs on timely ethics submissions and essential document maintenance • Ensure the TMF is complete, accurate, and inspection-ready • Oversee clinical monitoring activities and CRA training when required • Support study sites with materials and resources • Collaborate with Data Management on CRF compliance, data review, query resolution, and database lock timelines • Partner with Clinical Operations to ensure monitoring complies with sponsor expectations, SOPs, regulations, GCP, and study requirements • Contribute to Clinical Monitoring Plans • Provide project-specific CRA training and conduct site initiation visits for single-site studies when needed • Develop annotated site visit reports and monitoring tools • Mentor junior staff and support onboarding • Provide technical, therapeutic, and project management expertise for departmental training and process improvement • Participate in business development activities and contribute to operational tool and process improvement initiatives

🎯 Requirements

• A Bachelor's degree (B.Sc.) in a field related to clinical research • At least 5 years of experience in the clinical research industry, including a minimum of 3 years of project management experience in Phase I and Phase II clinical trials • Experience managing multiple clinical trials simultaneously across several study sites • Previous experience in dermatology clinical trials, which is strongly preferred • Strong knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, FDA requirements, and applicable local regulations • Proficiency with the Microsoft Office Suite • Excellent written and verbal communication skills in English • Bilingualism in English and French is highly desirable • Ability to work effectively in a collaborative team environment and build strong relationships with colleagues, sponsors, and other stakeholders • Strong problem-solving, critical-thinking, and creative-thinking skills • Solid scientific understanding and clinical research knowledge • Broad cross-functional knowledge of clinical research operations • Ability to manage multiple projects, prioritize competing demands, and perform effectively under pressure while meeting deadlines • Knowledge of Good Clinical Practices as well as applicable Health Canada and FDA regulations and guidelines • Legally authorized to work in Romania

🏖️ Benefits

• Permanent full-time position • Flexible schedule • Vacation • Home-based position • Ongoing learning and development • Attractive advancement opportunities