Project Manager

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

📋 Description

• Facilitate the successful initiation, planning, execution, monitoring, controlling, and closure of assigned clinical research projects.

• Ensure adherence to study budgets, project scope, timelines, SOPs, good clinical practices, regulatory requirements, and study-specific obligations.

• Act as the primary liaison for sponsors, vendors, and internal teams during the study.

• Coordinate responsibilities and deadlines among departments involved in the project.

• Supervise project coordinators, SSU team members, RDA, and RAC resources, prioritizing site activation tasks.

• Manage vendor supplies and services in alignment with site activation schedules.

• Report any potential delays in site activation timelines to the Project Manager II.

• Address sponsor and stakeholder needs and expectations effectively.

• Ensure project team members receive necessary training and maintain the project-specific training matrix.

• Plan project activities and allocate required resources efficiently.

• Oversee the quality of assigned tasks and deliverables.

• Provide project status updates to both internal and external stakeholders.

• Reconcile study trackers and assess planned versus actual outcomes.

• Engage in corrective actions, change control, and risk management processes.

• Review and contribute to the drafting of project operational plans, processes, and manuals.

• Ensure that study documents and deliverables comply with applicable country standards.

• Oversee site selection, feasibility questionnaires, and planning for site qualification visits.

• Monitor patient recruitment and subject status; follow up on recruitment strategies.

• Engage in planning and conducting Investigator's Meetings.

• Supervise central ethics and regulatory submissions in collaboration with Regulatory Affairs.

• Collect and maintain essential site documentation throughout the study duration.

• Assist with TMF quality reviews and audits to ensure inspection readiness.

• Support clinical monitoring activities, including CRA training, review of visit reports, site letters, and addressing escalated site issues.

• Track site visits, project-specific training, monitoring reports, follow-up letters, and site-related escalations.

• Provide support to sites with investigational products, study supplies, equipment, and safety lab kits.

• Collaborate with Data Management to ensure CRF compliance, resolve queries, and review data leading up to database lock.

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

⛳️ Requirements

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

• A minimum of 3 years of experience in a similar role, encompassing management of clinical studies within the pharmaceutical, biotechnology, and/or CRO sectors.

• At least 2 years of experience coordinating clinical trial management activities.

• In-depth knowledge of GCP and ICH standards, along with FDA and Canadian regulations.

• Proficient in Microsoft Office Suite.

• Exceptional oral and written communication skills in English; proficiency in French is a plus.

• Strong interpersonal communication abilities.

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

• Effective problem-solving skills.

• Strong organizational capabilities.

• Proven ability to manage multiple projects and work under pressure while meeting deadlines.

• Experience managing small to medium projects with a disciplined project management approach.

• Demonstrated ability to develop and implement resource-based project plans successfully.

• Outstanding people management skills; experience in working with and leading teams in a matrix environment.

• Candidates must have the legal right to work in Germany.

🏝️ Benefits

• Engaging work environment.

• Attractive opportunities for advancement.

• Remote position based in Germany.

• Equal opportunity and accommodation provided throughout the recruitment and selection process, upon request.