Senior Clinical Project Manager - Remote US

Unipharmedtech; Northern (KY); Hybrid; USD 150,000 - 175,000; Full time

Job summary

Uniphar is seeking a Senior Clinical Project Manager to lead clinical operations on multi-site trials from start-up to database lock, ensuring adherence to FDA/ICH-GCP guidelines and SOPs. You will manage CROs, monitor progress, and maintain study quality while coordinating with internal teams and external partners.

The role offers US remote work with a strong emphasis on budget oversight, timelines, and cross-functional collaboration across Phase I–III trials.

Qualifications

• Eight or more years of clinical trial management experience in pharma, biotechnology, or CRO settings.
• Two years of project management experience; at least 4 years of monitoring experience.
• Experience across Phase I–III, including global trials with multiple CROs.
• Strong understanding of FDA regulations and ICH-GCP guidelines.

Responsibilities

• Manages all study-related activities to meet defined timelines and budgets while ensuring GCP/ICH guidelines are met.
• Oversees CROs and service providers involved in the study.
• Leads development of study documents such as Clinical Project Plans, Informed Consent, CRFs, Monitoring Plan, and Safety Plans.
• Oversees investigator recruitment and site initiation activities.
• Monitors data collection, query resolution, and protocol adherence; escalates issues as needed.
• Provides regular status updates to Senior Management and participates in audits and vendor negotiations.

Skills

Vendor management

Project management

Regulatory knowledge

Communication skills

Clinical operations

Education

BS/BA degree or equivalent

Advanced degree preferred

Tools

Microsoft Outlook

Excel

Word

PowerPoint

Project

Job description

Uniphar is seeking a Senior Clinical Project Manager to lead clinical operations on multi-site trials from start-up to database lock, ensuring adherence to FDA/ICH-GCP guidelines and SOPs. You will manage CROs, monitor progress, and maintain study quality while coordinating with internal teams and external partners.

The role offers US remote work with a strong emphasis on budget oversight, timelines, and cross-functional collaboration across Phase I–III trials.