Project Manager

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

📋 Description

• Ensure the effective initiation, planning, execution, monitoring, controlling, and closure of designated clinical research projects.

• Maintain adherence to study budgets, project scopes, timelines, standard operating procedures, good clinical practices, regulatory guidelines, and study-specific requirements.

• Act as the main point of contact for sponsors, vendors, and internal teams throughout the study lifecycle.

• Organize tasks and deadlines among departments involved in the project.

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

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

• Raise any risks to site activation timelines to the Project Manager II.

• Address sponsor and stakeholder needs and expectations effectively.

• Ensure that team members receive adequate training related to the project.

• Plan project activities and allocate resources accordingly.

• Oversee the quality of assigned work and deliverables.

• Provide stakeholders with project status updates.

• Reconcile study trackers and assess planned versus actual outcomes.

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

• Assist in reviewing and drafting project operational plans, processes, and manuals.

• Ensure that study documents and deliverables align with applicable country regulations.

• Supervise site selection and qualification processes.

• Monitor patient recruitment and subject status closely.

• Participate in Investigator’s Meetings.

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

• Ensure the collection and maintenance of essential site documents.

• Assist with quality reviews and audits of the Trial Master File.

• Support clinical monitoring activities and address escalated site issues.

• Track site visits, training, monitoring reports, follow-up letters, and compliance.

• Maintain a project-specific training matrix.

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

• Support CRF compliance, query resolution, and data review up to database lock.

• Provide technical, therapeutic, and project management expertise in training and process improvement.

⛳️ Requirements

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

• A minimum of 3 years of experience in a comparable role, including management of clinical studies within the pharmaceutical, biotechnology, and/or CRO industries.

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

• Strong 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 skills.

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

• Strong problem-solving abilities.

• Good organizational skills.

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

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

• Demonstrated capability to establish and execute resource-based project plans.

• Excellent people management skills, with experience in leading teams in a matrix environment.

• Must have legal eligibility to work in the EU.

🏝️ Benefits

• Permanent full-time position.

• Flexible work schedule.

• Vacation benefits.

• Home-based work opportunity.

• Continuous learning and development opportunities.

• Attractive prospects for advancement.

• Commitment to equitable treatment and equal opportunity.

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