Project Manager II

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

📋 Description

• Assume full responsibility for the successful initiation, planning, execution, monitoring, control, and closure of assigned clinical trials.

• Supervise and coordinate study resources to ensure adherence to the study budget, project scope, timelines, SOPs, GCP, regulatory, and study-specific requirements.

• Serve as the primary point of communication for relevant stakeholders.

• Contribute to feasibility assessments, study design, and budget formulation, while ensuring progress reporting.

• Act as the main contact for the Sponsor, providing timely updates on trial progress.

• Facilitate client calls.

• Oversee and actively engage in the preparation of study plans, protocols, informed consent forms, eCRFs, TLFs, and clinical study reports.

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

• Ensure sites have the necessary materials, investigational products, supplies, equipment, and safety lab kits.

• Lead study start-up activities, which include trial kick-off, TMF setup, site selection and activation, vendor setup, contracting, and budgeting.

• Collaborate with Regulatory Affairs on submissions and the compilation of essential documents.

• Work alongside Data Management on CRF alignment, data review, query resolution, and database lock timelines.

• Maintain studies in an audit-ready state and monitor the quality of study deliverables.

• Manage risks, implement control measures, address discrepancies, and respond to audits.

• Oversee project budgets and identify out-of-scope activities for change orders.

• Manage trial timelines, budgets, resources, vendors, recruitment status, and cross-functional deliverables.

• Communicate with study teams, functional departments, and senior management.

• Lead the core project team and ensure sufficient project training.

• Coordinate with Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, and Scientific Affairs.

• Maintain project-specific training matrices and up-to-date training records.

⛳️ Requirements

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

• A minimum of 5 years of industry experience.

• At least 3 years of experience in managing Phase I-III clinical trial projects.

• Experience in managing dermatology and/or rheumatology trials.

• Proven experience leading concurrent multi-centered clinical trials with budgets exceeding $3M USD.

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

• Proficient in Microsoft Office suite.

• Exceptional verbal and written communication skills in English.

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

• Strong problem-solving skills.

• Good organizational abilities.

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

• Legally permitted to work in Romania.

🏝️ Benefits

• Permanent full-time employment.

• Flexible working hours.

• Vacation leave.

• Remote work opportunity.

• Continuous learning and development opportunities.

• Attractive opportunities for advancement.

• Recruitment and selection accommodations available for applicants with disabilities, upon request.