Project Manager ofertas em United States

We currently have an exciting new opportunity for an experienced Global Clinical Project Manager to join a successful sponsor-dedicated program. We are looking for a Global Clinical Project Manager, a business-critical role within Study Management, BioPharmaceuticals Clinical Operations, responsible for the delivery of clinical studies.

The Global Clinical Project Manager leads a cross-functional study team, providing direction and guidance to ensure successful study delivery. They serve as the main liaison between the study team and the Clinical Program Team (CPT), from study handover to close-out and archiving. The role is accountable for delivering studies on time, within budget, and to quality standards by fostering effective partnerships and teamwork.

This position oversees compliance with current clinical trial regulations (e.g., ICH GCP) and leads or oversees study teams and external vendors. It is a permanent, fully home-based role with ICON on FSP, requiring candidates to be located in Bulgaria, UK, Poland, or Spain.

1. Lead and guide cross-functional study teams or oversee outsourced activities to ensure progress according to milestones, timelines, budget, and quality standards. May oversee multiple studies.
2. Facilitate communication across all functions, including external partners and service providers.
3. Conduct investigator meetings and other study-related meetings.
4. Develop and ensure the accuracy of essential study documents, from Clinical Study Protocol (CSP) to Clinical Study Report (CSR), in line with SOPs.
5. Ensure external service providers perform as contracted, meeting goals and timelines, and escalate issues as needed. Participate in vendor selection if required.
6. Develop and maintain study plans, including quality and risk management strategies, with clear risk response and escalation processes.
7. Maintain up-to-date and accurate information in all study systems (e.g., ACCORD, ABACUS, PharmaCM).
8. Monitor study performance against plans and KPIs, communicating risks and mitigation strategies to stakeholders.
9. Identify and report quality issues, collaborate on corrective actions, and ensure TMF completeness and compliance with SOPs.
10. Ensure adherence to governance controls such as Delegation of Authority, Sunshine Act, and clinical trial transparency.
11. Manage study budgets, re-forecast as needed, and report financial risks and mitigation plans to the CPT.

Qualifications include a university degree in medical or biological sciences, at least 5 years of relevant clinical experience with 2 years in project management, an advanced degree, project management certification, and proven experience managing global clinical studies. Extensive knowledge of ICH-GCP, regulatory requirements, and clinical research processes is required. Candidates should possess strong leadership, communication, organizational, and problem-solving skills, with the ability to manage competing priorities.

Applicants must have current experience in the clinical research industry within Pharma or CRO settings, specifically in global study delivery, and the right to work without sponsorship in Spain, UK, Poland, or Bulgaria.