Project Manager II, Early Phase

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

📋 Description

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

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

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

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

• Supervise timelines, budgets, resources, vendor management, and clinical operations activities.

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

• Provide progress reports addressing site selection, vendor management, budgets, timelines, quality standards, and risk mitigation.

• Lead start-up activities for studies, including 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.

• Conduct meetings with clients, internal teams, and vendors; document and archive meeting minutes.

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

• Assess planned versus actual outcomes and implement corrective measures.

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

• Review and approve responses to quality assurance audits.

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

• Supervise TMF filing, maintenance, archiving, completeness, accuracy, and inspection readiness.

• Track recruitment performance and develop mitigation strategies.

• Participate in Investigator Meetings.

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

• Potentially oversee clinical monitoring activities and CRA training.

• Provide 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 the development of Clinical Monitoring Plans.

• Offer project-specific CRA training and possibly conduct site initiation visits.

• Create annotated site visit reports and monitoring tools.

• Potentially mentor junior team members and assist with onboarding.

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

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

• 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.

• At least 5 years of experience in the clinical research sector.

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

• Experience managing multiple clinical trials concurrently across various 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.

• Proficiency in the Microsoft Office Suite.

• Exceptional written and verbal communication skills in English.

• Bilingualism in English and French is highly desirable.

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

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

• Solid scientific knowledge and clinical research understanding.

• Comprehensive cross-functional knowledge of clinical research operations.

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

• Familiarity with Good Clinical Practices and applicable Health Canada and FDA regulations and guidelines.

• Legally authorized to work in Germany.

🏝️ Benefits

• Engaging work environment.

• Attractive opportunities for advancement.

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