Project Manager

Indero is a contract research organization specialized in dermatology and rheumatology. Founded in 2000, it provides clinical research and related services and operates in North America and Europe.

• Serve as a primary contact for the Sponsor, vendors, and internal team throughout the study;
• Coordinate tasks and deadlines between departments involved in the project;
• Oversee project coordinators, SSU team members, RDA, and RAC resources to prioritize site activation activities;
• Coordinate vendor supplies and services with site activation timelines;
• Escalate risks to site activation timelines to Project Manager II;
• Assist with managing Sponsor and internal and external stakeholder needs and expectations;
• Assist with ensuring that team members are adequately trained on the project;
• Plan project activities and required internal and external resources when applicable;
• Manage the quality of assigned work and deliverables;
• Provide project status updates to external and internal stakeholders;
• Ensure assigned tasks comply with the study budget, project scope, timelines, SOPs, GCP, regulatory, and study-specific requirements;
• Reconcile study trackers;
• Analyze discrepancies between planned and actual results and participate in corrective actions;
• Assist with change control and risk management throughout the project;
• Review and assist with drafting project operational plans, processes, and manuals;
• Ensure study-specific documents and project deliverables meet applicable country requirements;
• Oversee site selection activities, including feasibility questionnaires and site qualification visit planning;
• Monitor patient recruitment and subject status and follow up with sites on recruitment strategy plans;
• Participate in planning and conducting Investigator’s Meetings;
• Oversee central ethics and regulatory submissions in collaboration with Regulatory Affairs;
• Ensure collection and maintenance of required essential site documents;
• Assist with Trial Master File quality reviews and audits to support inspection readiness;
• Support clinical monitoring activities, including CRA training, visit report review, site letters, and escalated site issues;
• Track site qualification, initiation, routine, and close-out visits, project-specific training, monitoring visit reports, follow-up letters, monitoring plan compliance, and site-related issue escalations;
• Maintain the project-specific training matrix and confirm team member training before study tasks begin;
• Support sites and ensure they have the materials needed to conduct the study;
• Ensure CRF compliance with the protocol and Sponsor requirements and support query resolution and data review through database lock in collaboration with Data Management;
• Provide technical, therapeutic, and project management expertise in departmental training and process improvement.

• B.Sc. in a field related to clinical research;
• At least 3 years of experience in a similar role, including clinical study management in the pharmaceutical, biotechnology, or CRO industry;
• At least 2 years of experience coordinating clinical trial management activities;
• Excellent knowledge of GCP, ICH standards, FDA, and Canadian regulations;
• Excellent knowledge of Microsoft Office Suite;
• Excellent oral and written English skills;
• Excellent communication skills;
• Ability to work in a team and build strong relationships with colleagues and Sponsors;
• Good problem-solving abilities;
• Good organizational skills;
• Ability to manage multiple projects and work under pressure while meeting timelines;
• Experience managing small to medium projects using a disciplined project management approach;
• Ability to establish and deliver resource-based project plans;
• Excellent people management skills and experience working with and managing teams in a matrix environment;
• Nice to have: French.

• Vacation, PPK, and health allowance;
• Teleworking allowance;
• Ongoing learning and development;
• Candidates must be legally authorized to work in Poland.