Project Manager

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

📋 Description

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

• Ensure adherence to study budgets, project scope, timelines, standard operating procedures (SOPs), good clinical practices, regulatory requirements, and specific study guidelines.

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

• Coordinate tasks and deadlines among various 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 accordance with site activation timelines.

• Raise concerns regarding at-risk site activation timelines to the Project Manager II.

• Assist in managing the needs and expectations of sponsors and stakeholders.

• Support team training efforts and plan project activities and resources effectively.

• Ensure the quality of assigned work and deliverables.

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

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

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

• Review and aid in drafting operational plans, processes, and manuals for the project.

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

• Oversee site selection and qualification processes.

• Monitor patient recruitment, subject status, and site recruitment strategies.

• Participate in Investigator’s Meetings.

• Manage central ethics and regulatory submissions in conjunction with Regulatory Affairs.

• Gather and maintain essential site documents throughout the study duration.

• Assist with quality reviews of the Trial Master File and prepare for audits to ensure inspection readiness.

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

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

• Maintain the project training matrix and verify team member training prior to study tasks.

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

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

• Provide technical, therapeutic, and project management expertise during departmental training and process improvement initiatives.

⛳️ Requirements

• Bachelor’s degree in a 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 sectors.

• 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 the Microsoft Office suite.

• Excellent verbal and written communication skills in English.

• Proficiency in French is considered an asset.

• Outstanding communication abilities.

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

• Effective problem-solving skills.

• Strong organizational capabilities.

• Proven ability to manage multiple projects and perform under pressure while adhering to timelines.

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

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

• Excellent people management skills, with experience in working with and leading teams in a matrix structure.

• Applicants must have the legal right to work in Romania.

🏝️ Benefits

• Permanent full-time position.

• Flexible work schedule.

• Vacation time.

• Home-based work arrangement.

• Opportunities for ongoing learning and professional development.

• Attractive prospects for career advancement.