Project Manager II

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

📋 Description

• Assume overall responsibility for the effective initiation, planning, execution, monitoring, controlling, and closure of assigned clinical trials.

• Supervise and coordinate study resources to ensure adherence to budgets, project scope, timelines, SOPs, GCP, regulatory, and study-specific requirements.

• Serve as the primary point of contact for relevant stakeholders.

• Contribute to feasibility assessments, study design, and budget development.

• Ensure consistent progress reporting on resources, budget, and timeline.

• Act as the principal contact for the Sponsor, providing timely updates on trial progress.

• Facilitate client calls.

• Oversee and engage in the preparation of study plans, protocols, informed consent forms, eCRFs, TLFs, and clinical study reports.

• Participate in the planning and execution of Investigator’s Meetings.

• Ensure that sites are equipped with the necessary study materials and supplies.

• Lead study start-up activities, including trial kick-off, TMF setup, site selection and activation, vendor setup, contracting, and budgeting.

• Collaborate with Regulatory Affairs on submissions and essential documents.

• Partner with Data Management on CRF alignment, data review, query resolution, and database lock timelines.

• Maintain audit readiness for assigned studies.

• Monitor study deliverables and address any quality concerns.

• Manage risks and implement control measures.

• Analyze discrepancies between planned and actual outcomes.

• Review and approve responses to quality assurance audits.

• Control project budgets and identify out-of-scope activities for change orders.

• Manage trial timelines, budgets, resources, and vendors.

• Coordinate tasks and deliverables across functional departments.

• Communicate with study teams, functional departments, and senior management.

• Manage and report on recruitment status.

• Lead the core project team, ensuring adequate project training.

• Coordinate with vendors and internal teams to ensure timely completion of tasks and deliverables according to applicable standards.

• Define and maintain the project-specific training matrix and keep training records up to date.

⛳️ Requirements

• Bachelor’s degree in a field related to clinical research.

• A minimum of 5 years of industry experience.

• At least 3 years of experience in managing Phase I-III clinical trial projects.

• Experience in managing dermatology and/or rheumatology trials.

• Proven track record leading concurrent multi-centered clinical trials with budgets exceeding $3M USD.

• Thorough understanding of GCP and ICH standards, as well as FDA and Canadian regulations.

• Proficient in Microsoft Office suite.

• Excellent verbal and written communication skills in English.

• Proficiency in French is considered an asset.

• Exceptional communication abilities.

• Capability to work collaboratively in a team environment and build strong relationships with colleagues and sponsors.

• Strong problem-solving skills.

• Good organizational capabilities.

• Ability to manage multiple projects and work effectively under pressure while meeting deadlines.

• Must possess legal eligibility to work in Germany.

🏝️ Benefits

• Engaging work environment.

• Attractive opportunities for career advancement.

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