Project Manager II, Early Phase

This is a fully remote position, open to applicants in Romania.

📋 Description

• Oversee the initiation, planning, execution, monitoring, control, and closure of designated Phase I and Phase II clinical trials.

• Serve as the primary liaison for sponsors, vendors, and internal study teams throughout the entire clinical trial lifecycle.

• Manage study resources, deliverables, timelines, budgets, scope, vendors, and clinical operations across various departments.

• Collaborate with clients during study initiation to identify effective operational strategies.

• 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 assist in change order management.

• Provide regular updates on project status, including site selection, vendor management, budgets, timelines, quality standards, and risk mitigation.

• Facilitate 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 as necessary.

• Lead meetings with clients, internal teams, and vendors, ensuring thorough documentation of discussions.

• Supervise project deliverables and promote continuous improvement in training, execution, and quality processes.

• Assess planned versus actual project outcomes and implement corrective measures.

• Maintain study-specific training matrices and verify the accuracy of project training records.

• Review and approve responses to quality assurance audits.

• Ensure the timely completion and compliance of protocols, informed consent forms, eCRFs, source document templates, TLFs, and clinical study reports.

• Oversee the filing, maintenance, and archiving of study documentation in the TMF.

• Monitor recruitment performance and develop strategies for addressing enrollment risks.

• Participate in Investigator Meetings.

• Collaborate with Regulatory Affairs to ensure timely ethics submissions and maintenance of essential documents.

• Ensure the TMF is comprehensive, accurate, and ready for inspection.

• Oversee clinical monitoring activities and provide CRA training when necessary.

• Support study sites with materials and resources.

• Work closely with Data Management on CRF compliance, data review, query resolution, and database lock timelines.

• Partner with Clinical Operations to ensure monitoring aligns with sponsor expectations, SOPs, regulations, GCP, and study requirements.

• Contribute to the development of Clinical Monitoring Plans.

• Provide project-specific CRA training and conduct site initiation visits for single-site studies as required.

• Develop annotated site visit reports and monitoring tools.

• Mentor junior staff and assist with onboarding processes.

• Offer technical, therapeutic, and project management expertise for departmental training and process enhancement.

• Engage in business development activities and contribute to initiatives geared toward operational tool and process improvements.

⛳️ Requirements

• A Bachelor's degree (B.Sc.) in a discipline related to clinical research.

• A minimum of 5 years of experience in the clinical research field, including at least 3 years of project management experience in Phase I and Phase II clinical trials.

• Experience in managing several clinical trials concurrently across multiple study sites.

• Prior experience in dermatology clinical trials is strongly preferred.

• In-depth knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, FDA regulations, and relevant local laws.

• Proficiency in the Microsoft Office Suite.

• Exceptional written and verbal communication abilities in English.

• Bilingual proficiency in English and French is highly desirable.

• Capability to work effectively in a collaborative team environment and cultivate strong relationships with colleagues, sponsors, and other stakeholders.

• Strong problem-solving, critical thinking, and creative thinking skills.

• Solid understanding of scientific principles and clinical research.

• Extensive 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 employment.

• Flexible working hours.

• Vacation time.

• Remote work opportunity.

• Continuous learning and development opportunities.

• Attractive career advancement prospects.