Project Manager

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

📋 Description

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

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

• Act as the primary liaison for sponsors, vendors, and internal teams throughout the duration of the study.

• Coordinate tasks and deadlines across departments.

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

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

• Report risks to site activation timelines to Project Manager II.

• Manage the needs and expectations of sponsors and stakeholders.

• Facilitate team training and plan project activities and resource allocation.

• Ensure work quality and deliverables are met, while providing regular project status updates.

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

• Assist with corrective actions, change control, and risk management.

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

• Guarantee that study documents and deliverables comply with relevant country-specific requirements.

• Supervise site selection and feasibility assessments.

• Monitor patient recruitment and subject status, ensuring follow-up with sites.

• Participate in Investigator’s Meetings.

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

• Ensure the collection and upkeep of essential site documents.

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

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

• Track site visits, training sessions, monitoring reports, follow-up letters, and site-related concerns.

• Maintain the project-specific training matrix.

• Ensure sites have the necessary study materials and supplies.

• Assist with CRF compliance, query resolution, and data review leading up to database lock with Data Management.

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

⛳️ Requirements

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

• Minimum of 3 years of experience in a comparable role, encompassing management of clinical studies in the pharmaceutical, biotechnology, and/or CRO sectors.

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

• Strong understanding 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.

• Strong communication capabilities.

• Ability to collaborate effectively within a team environment and build positive relationships with colleagues and sponsors.

• Strong problem-solving skills.

• Excellent organizational abilities.

• Proven capacity to manage multiple projects and perform under pressure while meeting deadlines.

• Experience in managing small to medium-sized projects using a structured project management approach.

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

• Strong people management skills; experience in working with and leading teams in a matrix organization.

• Legally authorized to work in the EU.

🏝️ Benefits

• Permanent full-time employment.

• Flexible working hours.

• Paid vacation.

• Remote work opportunity.

• Continuous learning and development support.

• Attractive career advancement prospects.

• Equal opportunity and disability accommodations available throughout the recruitment and selection process upon request.