Project Manager II, Early Phase

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

📋 Description

• Lead the initiation, planning, execution, monitoring, controlling, and closure of assigned clinical trials.

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

• Collaborate with clients during study start-up to comprehend objectives and establish effective operational strategies.

• Maintain ongoing communication with sponsors, study teams, functional departments, clinical sites, and senior management.

• Supervise clinical trial timelines, budgets, resource allocation, vendor management, and clinical operations deliverables.

• Monitor study budgets, track hours worked, review billed time, identify out-of-scope activities, and assist with change order management.

• Provide updates on progress relating to site selection, vendor management, budgets, timelines, quality standards, and risk mitigation.

• Lead study start-up activities such as 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.

• Conduct client, internal team, and vendor meetings; document and maintain meeting minutes.

• Ensure the quality of deliverables and drive continuous improvement in training, execution, and quality processes.

• Evaluate planned project outcomes against actual results and implement corrective actions as needed.

• Maintain study-specific training matrices and ensure training records are up to date.

• Review and approve responses to quality assurance audits.

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

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

• Track recruitment performance and devise mitigation strategies for enrollment risks.

• Participate in Investigator Meetings.

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

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

• Supervise clinical monitoring activities and provide CRA training when required.

• Support study sites with necessary materials and resources.

• Collaborate with Data Management on CRFs, data review, query resolution, and database lock.

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

• Contribute to Clinical Monitoring Plans.

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

• Develop annotated site visit reports and monitoring tools.

• Mentor junior staff and assist with the onboarding of new employees when necessary.

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

• Engage in business development activities, including client meetings, proposal defenses, RFIs, and RFP responses when necessary.

• Contribute to the development, testing, and implementation of operational tools and processes.

⛳️ Requirements

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

• A minimum of 5 years of experience in the clinical research industry.

• At least 3 years of project management experience in Phase I and Phase II clinical trials.

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

• Previous experience in dermatology clinical trials is strongly preferred.

• Strong knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, FDA requirements, and relevant local regulations.

• Proficient in 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.

• Capability to manage multiple projects, prioritize competing demands, and perform effectively under pressure while meeting deadlines.

• Knowledge of Good Clinical Practices and applicable Health Canada and FDA regulations and guidelines.

• Applicants must be legally authorized to work in Spain.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Company benefits package.

• Ongoing learning and development opportunities.

• Attractive advancement opportunities.

• Equitable treatment and equal opportunity.

• Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request.