Clinical Trial Business Operations - Manager

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

Company: Pharmaceutical Company

Role: Clinical Trial Business Operations

Contract: 2 year W2 Contract

Location: Onsite in Bridgewater, NJ

Hourly rate: 100/hour

Start date: ASAP

Benefits: Medical, Dental, and Vision

A leading organisation is seeking a Clinical Trial Business Operations Manager for a two-year contract based in Bridgewater, NJ. This role is responsible for supporting the management and execution of clinical trial activities in compliance with GCP and relevant regulatory requirements. The successful candidate will collaborate closely with Clinical Operations Leads and Senior Clinical Trial Managers to coordinate cross-functional study teams, ensuring deliverables are achieved with high quality, on time, and within budget.

Key responsibilities include overseeing regional monitoring of site-level activities for ongoing and planned trials, supporting protocol compliance, safety, and data integrity at investigator sites, and participating in the development of trial synopses, protocols, amendments, and related study documents. The manager will contribute to site feasibility assessments, investigator engagement activities, and risk-based quality management initiatives. Additional duties involve implementing risk-based and centralized monitoring strategies, managing detailed project plans, and supporting vendor oversight through regular review of study metrics and quality assessments.

The ideal candidate will have a minimum of five years' clinical trial management experience within the pharmaceutical or biotechnology industry, including logistics management for clinical trials. Experience in rare disease and/or orphan indications and managing large, complex studies and project teams is preferred. Strong leadership skills, the ability to work independently, and proficiency in managing CROs and specialty vendors are essential. A thorough understanding of the drug development process, ICH/GCP requirements, and local regulations is required. Excellent written and oral communication, critical thinking, conflict resolution, and organisational skills are necessary.

A bachelor's degree is required for this position. Candidates must demonstrate the ability to work effectively in a matrixed team environment and exhibit strong collaboration, accountability, and integrity.

Must-Have Skills: clinical trial management, clinical trial execution, ICH, GCP requirements, local regulations, regional monitoring oversight, managing CROs

Nice-to-Have Skills: site feasibility assessments, risk-based quality management, risk-based monitoring, centralized monitoring, clinical trial synopses, protocols, case report forms, IRB, ethics applications, recruitment materials, informed consent forms, study guidelines, operations manuals, training materials, study plans, investigator engagement, data integrity, patient safety, project plans, study metrics, milestone tracking, quality assessments, contractual obligations, database lock milestones, patient profiles, data listings, trial master file, drug development process, interpretation, written, oral communication, collaboration, conflict resolution, problem-solving, critical thinking, working independently, matrixed team environment, leadership

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.