Single Sponsor Clinical Project Manager II UK (Oncology)

Job Responsibilities

• Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOPs, and regulatory requirements.
• Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to contractual agreements.
• Leads the project team to ensure quality, timelines, and budget management, and is accountable for the financial performance of each project.
• Coordinates activities and deliverables of all study conduct partners and proactively identifies and manages issues.
• Ensures studies are conducted in compliance with GCP and regulatory requirements, and is accountable for all project deliverables.
• Responsible for the quality and completeness of TMF for assigned projects and for maintenance of study information on a variety of databases and systems.
• Oversees inspection readiness activities for all aspects of study conduct.
• Develops and implements project plans, contingency planning, and risk mitigation strategies to ensure successful delivery of study goals.
• Plans, coordinates, and presents at internal and external meetings, and prepares project management reports for clients and management.
• Develops strong relationships with current clients to generate new and/or add‑on business for the future and may participate in bid defense meetings where the project manager is presented as a potential lead.
• May be required to line‑manage other project management team members and clinical monitoring staff.

Qualifications

• Bachelor’s Degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing, or a comparable combination of education and experience.
• Clinical research organization (CRO) experience and relevant therapeutic area experience preferred.
• Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
• Strong organizational skills, sound time‑management, and ability to work independently.
• Direct therapeutic area expertise and willingness to embrace new technologies.
• Excellent communication, presentation, interpersonal, written, and spoken skills.
• Ability to travel as necessary (approximately 25%).

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations when appropriate, and to the EU Equality Directive in relation to recruitment and employment.