Strategic Clinical Trial Operations Lead

Real Staffing Group; Bridgewater (MA); On-site; USD 110,000 - 193,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Job summary

Pharmaceutical Company seeks a Clinical Trial Business Operations Manager for a two-year W2 contract in Bridgewater, NJ. You will coordinate cross-functional study teams to ensure trials are delivered on time, within budget, and in compliance with ICH/GCP standards.

Responsibilities include overseeing regional site monitoring, supporting protocol compliance, safety and data integrity, and contributing to study documents, feasibility, investigator engagement, and risk-based quality initiatives.

Qualifications

• Minimum 5 years in clinical trial management in pharma/biotech.
• Experience with rare diseases and large, complex studies preferred.
• Strong leadership and CRO/vendor management skills.
• Knowledge of ICH/GCP and local regulations.
• Bachelor's degree required.

Responsibilities

• Oversee regional site monitoring for ongoing and planned trials.
• Support protocol compliance, safety, and data integrity at sites.
• Develop trial synopses, protocols, amendments, and study documents.
• Assist in site feasibility and investigator engagement.
• Monitor risk-based quality initiatives and metrics.

Skills

Clinical Trial Mgmt

GCP compliance

Regulatory knowledge

CRO management

Cross-functional leadership

Site monitoring

Education

Bachelor's degree

Job description

Pharmaceutical Company seeks a Clinical Trial Business Operations Manager for a two-year W2 contract in Bridgewater, NJ. You will coordinate cross-functional study teams to ensure trials are delivered on time, within budget, and in compliance with ICH/GCP standards.

Responsibilities include overseeing regional site monitoring, supporting protocol compliance, safety and data integrity, and contributing to study documents, feasibility, investigator engagement, and risk-based quality initiatives.