Senior Clinical Trial Operations Lead

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

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings benefits

Life insurance

Disability benefits

Parental leave

Paid time off for sick leave and VAC

Job summary

Precision Medicine Group is seeking a clinical trial lead to oversee the operational aspects of clinical studies, ensuring adherence to protocol, SOPs, ICH-GCP, and regulatory requirements. You will manage feasibility, site start-up, enrollment, and quality deliverables while coordinating with PM, CRAs, and regulatory teams.

The role emphasizes cross-functional leadership, monitoring plan execution, and CAPA development to maintain timelines and data integrity across studies.

Qualifications

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred.
• Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience.
• Advanced degree preferred.

Responsibilities

• Act as the primary clinical point of contact with the client.
• Collaborate with PM on monthly invoicing and budget variance management.
• Develop study related clinical documents (plans, ICF templates, CRF guidelines, training materials).
• Identify training needs for CRAs and vendors and present at meetings.
• Lead site feasibility, recruitment strategies, and feasibility analysis.

Skills

Communication skills

Travel ability

Interpersonal skills

Education

Bachelor’s degree in science/health

Advanced degree preferred

Tools

Microsoft Office

Job description

Precision Medicine Group is seeking a clinical trial lead to oversee the operational aspects of clinical studies, ensuring adherence to protocol, SOPs, ICH-GCP, and regulatory requirements. You will manage feasibility, site start-up, enrollment, and quality deliverables while coordinating with PM, CRAs, and regulatory teams.

The role emphasizes cross-functional leadership, monitoring plan execution, and CAPA development to maintain timelines and data integrity across studies.