Project Manager

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

📋 Description

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

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

• Act as the primary liaison for sponsors, vendors, and internal teams throughout the studies.

• Coordinate tasks and deadlines across various departments.

• 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.

• Escalate risks related to site activation timelines to the Project Manager II.

• Address sponsor and stakeholder needs and expectations.

• Ensure team members receive adequate training on projects.

• Plan project activities and identify necessary internal and external resources.

• Oversee the quality of assigned work and deliverables.

• Provide project status updates to stakeholders.

• Reconcile study trackers and analyze discrepancies between planned and actual outcomes.

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

• Review and assist in drafting project operational plans, processes, and manuals.

• Ensure study documents and deliverables comply with country-specific requirements.

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

• Monitor patient recruitment and strategies for site recruitment.

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

• Supervise central ethics and regulatory submissions alongside Regulatory Affairs.

• Collect and maintain essential site documents throughout the duration of studies.

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

• Support clinical monitoring activities, including CRA training, visit report reviews, site letters, and addressing escalated site issues.

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

• Maintain project training matrices and verify team training compliance.

• Support sites with investigational products, study supplies, equipment, and safety lab kits.

• Collaborate with Data Management to ensure CRF compliance, query resolution, and data review until database lock.

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

⛳️ Requirements

• B.Sc. in a field related to clinical research.

• Minimum of 3 years of experience in a similar position, including management of clinical studies within the pharmaceutical, biotechnology, and/or CRO industry.

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

• Strong knowledge of GCP and ICH standards, as well as FDA and Canadian regulations.

• Proficient in Microsoft Office Suite.

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

• Excellent communication abilities.

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

• Strong problem-solving skills.

• Good organizational capabilities.

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

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

• Demonstrated ability to create and deliver resource-based project plans.

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

• Must be legally authorized to work in the EU.

🏝️ Benefits

• Permanent full-time position.

• Flexible schedule.

• Vacation.

• Home-based position.

• Continuous learning and development opportunities.

• Attractive opportunities for advancement.

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