Remote Senior Clinical Trial Lead

Precision Medicine Group; Peapack-Gladstone (NJ); Remote; USD 111,000 - 201,000; Full time

Benefits offered by this job

Discretionary bonus

Health insurance

Retirement savings

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group seeks a Clinical Trial Manager/Senior Clinical Trial Manager to lead the operational execution of US-based clinical studies from a remote setting. The role requires overseeing planning, site management, regulatory submissions, data integrity, and cross-functional collaboration with PMs, CRAs and QA.

The candidate will develop trial-related documents, ensure adherence to ICH-GCP and SOPs, and manage budgets, timelines and study metrics while guiding investigators and

Qualifications

• Bachelor’s degree in science or health-related field; advanced degree preferred.
• Minimum 7 years of clinical research experience or proven competencies with significant clinical monitoring experience.

Responsibilities

• Serve as the clinical trial lead responsible for planning, conduct and oversight of the operational portion of studies.
• Act as primary clinical contact with the client and collaborate on budgeting and invoicing.
• Develop study documents, forms, manuals and training materials.
• Identify training needs for CRAs and third-party vendors and present at Investigator Meetings.
• Drive site feasibility, recruitment/retention strategies and ongoing site/start-up activities.
• Lead internal clinical team meetings and set expectations for CRAs and CTAs.
• Oversee regulatory submissions and IP release packages; support CAPA and audits.
• Manage IP and drug accountability, data quality and data cleaning timelines.
• Escalate CRA performance and site compliance issues; support resourcing and vendor management.

Skills

Communication

Organizational skills

Interpersonal skills

Travel willingness

ICH-GCP knowledge

MS Office

Cross-functional teamwork

Negotiation

Leadership

Data management understanding

Education

Bachelor’s degree in science or health-related field

Advanced degree preferred

Tools

Microsoft Office

Job description

Precision Medicine Group seeks a Clinical Trial Manager/Senior Clinical Trial Manager to lead the operational execution of US-based clinical studies from a remote setting. The role requires overseeing planning, site management, regulatory submissions, data integrity, and cross-functional collaboration with PMs, CRAs and QA.

The candidate will develop trial-related documents, ensure adherence to ICH-GCP and SOPs, and manage budgets, timelines and study metrics while guiding investigators and