Senior Clinical Project Leader – Oncology (Remote)

United BioSource; United States; Remoto; USD 120.000 - 170.000; Tempo pieno

Vantaggi offerti da questo lavoro

Remote opportunities

401K with company match

Flexible work environment

Paid Holidays

Health benefits

Descrizione del lavoro

United BioSource is seeking a Senior Clinical Project Research Manager to lead study teams from startup through close-out in a fast-paced oncology CRO environment. This role requires managing sponsor relationships, budgets, timelines, and cross-functional collaboration to deliver contracted milestones.

The ideal candidate will have a BA degree or equivalent project management experience, strong supervisory and presentation skills, and deep regulatory knowledge (GCP/ICH).

Competenze

• BA Degree or minimum 5 years of direct project management experience at a CRO or proven leadership/management experience.
• Excellent supervisory skills.
• Excellent interpersonal skills.
• Excellent presentation skills.
• Very good knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.)
• 10% travel

Mansioni

• Serve as the primary sponsor contact for all study related items, overseeing start-up through close-out per SOPs, budgets, timelines and contracts.
• Execute operational aspects of assigned project activities and special projects.
• Assist in development and design of protocols, CRFs, regulatory documents, project master files, and other deliverables.
• Develop and monitor communication plans, monitoring plans, project plans, training plans and study timelines; ensure compliance.
• Plan investigator meetings, recruit investigators and assist in budget negotiations.
• Supervise PMs and team members to ensure timely deliverables; report progress to Sponsor.
• Lead projects with cross-functional involvement and supervise supporting functions.
• Assist in revenue and invoicing for projects; ensure training occurs.
• Serve as a resource for site management, budgeting, regulatory document prep, and issue resolution.
• Lead client teleconferences/meetings and present project information at client meetings and reviews.
• Maintain project documentation to be audit-ready; support audits as required.
• Assist in preparation of client proposals in response to RFPs.

Conoscenze

Project management

Supervisory skills

Interpersonal skills

Presentation skills

Regulatory knowledge

Travel awareness

Formazione

BA Degree

Descrizione del lavoro

United BioSource is seeking a Senior Clinical Project Research Manager to lead study teams from startup through close-out in a fast-paced oncology CRO environment. This role requires managing sponsor relationships, budgets, timelines, and cross-functional collaboration to deliver contracted milestones.

The ideal candidate will have a BA degree or equivalent project management experience, strong supervisory and presentation skills, and deep regulatory knowledge (GCP/ICH).