Project Manager II, Early Phase

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🔥 0 minutes ago

🇧🇬 Bulgaria – 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, controlling, and closure of assigned clinical trials • Serve as the main point of contact for sponsors, vendors, and internal study teams throughout the clinical trial lifecycle • Work with clients during study start-up to understand goals and determine effective operational approaches • Maintain communication with sponsors, study teams, functional departments, clinical sites, and senior management • Oversee clinical trial timelines, budgets, resources, vendor management, and clinical operations deliverables • Monitor and control study budgets, including billed time, out-of-scope activities, and change orders • Provide stakeholder updates on study progress, sites, vendors, budgets, timelines, quality, and risk mitigation • Lead study start-up activities, including kick-off meetings, TMF setup, site selection and activation, vendor onboarding, contracting, and budget negotiations • Identify and manage risks, implement quality controls, and escalate issues when necessary • Lead client, internal, and vendor meetings and maintain meeting documentation • Oversee project deliverables and drive continuous improvement in training, execution, and quality processes • Implement corrective actions based on planned versus actual outcomes • Maintain study-specific training matrices and verify current 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 • Oversee TMF filing, maintenance, archiving, and inspection readiness • Track recruitment and develop mitigation plans for enrollment risks • Participate in Investigator Meetings • Coordinate with Regulatory Affairs on ethics submissions and essential documents • May oversee clinical monitoring activities, CRA training, and monitoring oversight • Support study sites with required materials and resources • Collaborate with Data Management on CRFs, data review, query resolution, and database lock • Partner with Clinical Operations to ensure compliant monitoring activities • Contribute to Clinical Monitoring Plans • Provide project-specific CRA training and may conduct site initiation visits • Develop annotated site visit reports and monitoring tools • May mentor junior staff and support onboarding • Provide technical, therapeutic, and project management expertise for training and process improvement • May participate in business development activities, including client meetings, proposal defenses, RFIs, and RFP responses • May contribute to developing, testing, and implementing operational tools and processes

🎯 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 • The 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 • The 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 Bulgaria

🏖️ Benefits

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