Project Manager II, Early Phase

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

📋 Description

• Direct the initiation, planning, execution, monitoring, controlling, and closure of designated clinical trials.

• Act as the primary liaison for sponsors, vendors, and internal study teams throughout the clinical trial process.

• Collaborate with clients during study initiation to understand objectives and establish effective operational strategies.

• 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 manage study budgets, including billed time, out-of-scope activities, and change orders.

• Provide updates to stakeholders regarding study progress, sites, vendors, budgets, timelines, quality, and risk management.

• Lead study initiation 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 as necessary.

• Lead meetings with clients, internal teams, and vendors, ensuring documentation is maintained.

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

• Implement corrective measures based on discrepancies between planned and actual outcomes.

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

• Review and authorize responses to quality assurance audits.

• Ensure that protocols, informed consent forms, eCRFs, source document templates, TLFs, and clinical study reports are completed on time.

• Manage TMF filing, maintenance, archiving, and readiness for inspection.

• Monitor recruitment efforts and develop plans to mitigate enrollment risks.

• Participate in Investigator Meetings.

• Coordinate with Regulatory Affairs on ethics submissions and necessary documents.

• May supervise clinical monitoring activities, CRA training, and monitoring oversight.

• Assist study sites with the necessary 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 potentially conduct site initiation visits.

• Develop annotated site visit reports and monitoring tools.

• May mentor junior staff and assist with onboarding processes.

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

• May engage in business development activities, including client meetings, proposal defenses, RFIs, and RFP responses.

• May assist in the development, testing, and implementation of operational tools and processes.

⛳️ Requirements

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

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

• Proven experience managing multiple clinical trials concurrently across various study sites.

• Previous involvement in dermatology clinical trials is strongly preferred.

• Extensive 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 skills in English.

• Bilingual proficiency in English and French is highly desirable.

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

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

• Solid understanding of scientific principles and clinical research.

• Comprehensive cross-functional knowledge of clinical research operations.

• Competence in managing multiple projects, prioritizing competing demands, and performing well under pressure while meeting deadlines.

• Knowledge of Good Clinical Practices as well as relevant Health Canada and FDA regulations and guidelines.

• Legally authorized to work in Bulgaria.

🏝️ Benefits

• Permanent full-time position.

• Flexible work schedule.

• Vacation time.

• Home-based position.

• Continuous learning and development opportunities.

• Attractive career advancement prospects.