Senior Clinical Trial Lead, Operations & Compliance

precisionmedicinegroup; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

precisionmedicinegroup is seeking a Clinical Trial Lead to plan, conduct, and oversee the operational aspects of complex studies. You will ensure adherence to protocol, ICH-GCP, and regulatory requirements while partnering with clients and internal teams.

You will manage study documents, training materials, site feasibility, budgets, CAPA, and audits readiness, guiding CRAs, CTAs, and cross-functional teams to deliver on timelines and quality.

Qualifications

• Bachelor’s degree in science or health; advanced degree preferred.
• 7+ years clinical research experience with monitoring.
• Experience with Radiopharmaceuticals and/or CAR-T studies (preferred).

Responsibilities

• Lead planning, conduct and oversight of clinical studies per protocol and SOPs.
• Serve as primary client contact and coordinate with PM on budgets and invoicing.
• Develop study documents and training materials (e.g. ICF templates, CRF guidelines).
• Identify training needs for CRAs and vendors; present at investigator meetings.
• Ensure compliance with ICH-GCP and regulatory requirements; manage CAPA and audits.

Skills

Excellent communication

Interpersonal skills

Organizational skills

Travel ability (domestic & intl)

Education

Bachelor's degree in science or health field

Tools

Microsoft Office

Job description

precisionmedicinegroup is seeking a Clinical Trial Lead to plan, conduct, and oversee the operational aspects of complex studies. You will ensure adherence to protocol, ICH-GCP, and regulatory requirements while partnering with clients and internal teams.

You will manage study documents, training materials, site feasibility, budgets, CAPA, and audits readiness, guiding CRAs, CTAs, and cross-functional teams to deliver on timelines and quality.