Project Manager II, Early Phase (Romania)

DescriptionThe Project Manager II, EPTR has the overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials. The Project Manager II, EPTR oversees and coordinates study resources to ensure compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements. The Project Manager II, EPTR acts as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development and ensures progress reporting (resources, budget and timeline).

More specifically, the Project Manager II, Early Phase and Translational Research (EPTR):

• Acts as the main point of contact for sponsors, vendors, and internal study teams throughout the lifecycle of a clinical trial.

• Works closely with clients at study start-up to understand their goals and help determine the most effective operational approach.

• Maintains regular communication with sponsors, study teams, functional departments, clinical sites, and senior management.

• Oversees all operational aspects of clinical trials, including timelines, budgets, resources, vendor management, and clinical operations activities, while coordinating deliverables across departments.

• Monitors and controls study budgets by tracking hours, reviewing billed time, identifying out-of-scope activities, and supporting change order management.

• Provides regular updates to internal and external stakeholders on study progress, including site selection, vendor management, budgets, timelines, quality standards, and risk mitigation efforts.

• Leads study start-up activities, including kick-off meetings, Trial Master File (TMF) setup, site selection and activation, vendor onboarding, site contracting, and budget negotiations.

• Identifies and manages risks, implements quality control measures, and escalates issues to management, quality assurance, or sponsors when necessary.

• Leads client meetings, internal team meetings, and vendor status calls, ensuring meeting minutes are documented, distributed, and filed appropriately.

• Oversees the quality of project deliverables, including vendor and subcontractor outputs, and drives continuous improvement in training, execution, and quality processes.

• Evaluates differences between planned and actual project outcomes and implements corrective actions when required.

• Ensures study-specific training matrices are customized, maintained, and up to date.

• Verifies that all team members and service providers receive adequate project training and that training records remain current.

• Reviews and approves responses to quality assurance audits to ensure compliance with company procedures and regulatory requirements.

• Ensures key study documents and deliverables, such as protocols, informed consent forms, eCRFs, source document templates, tables/listings/figures, and clinical study reports, are completed on schedule and meet study requirements.

• Oversees the filing, maintenance, and archiving of study documentation within the TMF in compliance with company SOPs and regulatory requirements.

• Provides project status updates while ensuring compliance with budgets, scope, timelines, SOPs, Good Clinical Practice (GCP), regulatory requirements, and study-specific procedures.

• Tracks recruitment performance and develops mitigation plans when enrollment timelines are at risk.

• Participates in the planning and execution of Investigator Meetings.

• Works with Regulatory Affairs to ensure ethics submissions are completed on time and that essential documents are collected and maintained throughout the study.

• Ensures the TMF remains complete, accurate, and inspection-ready at all times.

• May oversee clinical monitoring activities, including site qualification, initiation, routine monitoring, and close-out visi...