Clinical Trial Business Operations Manager

Meet Life Sciences Ltd.; Bridgewater Township (NJ); On-site; USD 110,000 - 160,000; Full time

Job summary

Meet Life Sciences Ltd. in New Jersey is seeking an experienced clinical trial professional to manage and execute studies in collaboration with Clinical Operations leadership. You will ensure trials comply with GCP, regulatory requirements, and study timelines and budgets.

The role emphasizes CRO/vendor oversight, RBQM, risk-based monitoring, data review, and inspection readiness, with opportunities to lead multi-regional trials and mentor junior staff.

Qualifications

• Minimum 5 years of clinical trial management experience in pharma/biotech.
• Solid understanding of ICH/GCP and local regulations.
• Experience managing CROs and external vendors.
• Ability to coordinate cross-functional study teams and manage competing priorities.

Responsibilities

• Support planning, management, and execution of clinical trial activities per ICH/GCP and guidelines.
• Coordinate cross-functional study team activities to ensure on-time and within-budget deliverables.
• Oversee regional trial activities and monitor site-level progress of studies.
• Address protocol compliance, patient safety, data quality, and site issues with action plans.
• Develop and review study documentation, CRFs, informed consent, and manuals.
• Collaborate on site feasibility with Clinical Development, Medical Affairs, and Clinical Operations.
• Engage with Medical Liaisons for investigator engagement and meetings.

Skills

Clinical trial management

ICH/GCP knowledge

CRO/vendor oversight

Cross-functional coordination

Site oversight

RBQM

Data review

Investigator meetings

Project milestones

Documentation

Patient safety

Education

Bachelor's degree in life sciences

Job description

We are seeking an experienced clinical trial professional to support the management and execution of clinical studies within a pharmaceutical or biotechnology environment. This role will partner closely with Clinical Operations leadership and cross-functional study teams to ensure clinical trials are conducted in compliance with Good Clinical Practice (GCP), applicable regulations, and established study timelines and budgets.

The ideal candidate will bring strong clinical trial management experience, demonstrated CRO and vendor oversight capabilities, and the ability to coordinate complex study activities across cross-functional teams. Experience in rare disease or orphan indications is preferred, along with a strong understanding of clinical trial operations, risk-based monitoring, data review, and inspection readiness.

Key Responsibilities

• Support Clinical Operations Leads and Senior Clinical Trial Managers in the planning, management, and execution of clinical trial activities in accordance with ICH/GCP requirements and applicable regulatory guidelines.
• Coordinate cross-functional clinical study team activities to ensure deliverables are completed with high quality, on time, and within budget.
• Oversee assigned regional trial activities and monitor site-level progress across ongoing and planned clinical studies.
• Develop and support action plans to address protocol compliance, patient safety, data quality, and administrative issues at investigator sites.
• Contribute to the development and review of clinical trial protocols, amendments, case report forms (CRFs), informed consent forms, study guidelines, operational manuals, training materials, and other study documentation.
• Participate in site feasibility assessments in collaboration with Clinical Development, Medical Affairs, and Clinical Operations to evaluate site capabilities, investigator experience, patient populations, and enrollment potential.
• Collaborate with regional Medical Science Liaisons, as applicable, to support investigator engagement and related meetings or conference activities.
• Participate in Risk-Based Quality Management (RBQM) activities and support the implementation of risk-based and centralized monitoring strategies in collaboration with CROs, where applicable.
• Develop and maintain detailed study plans, timelines, milestones, and other trial-related project documentation.
• Support the planning and execution of investigator meetings, study kickoffs, monitoring training sessions, and CRO or vendor meetings.
• Monitor CRO and vendor performance through regular review of study metrics, milestones, quality assessments, and contractual deliverables.
• Identify potential changes in vendor scope, costs, or timelines and collaborate with Clinical Operations leadership to support appropriate documentation and resolution.
• Partner with Data Management, Clinical Development, CROs, and other functional teams to support ongoing data review and achieve database lock milestones.
• Support inspection readiness throughout the study lifecycle, including Trial Master File (TMF) maintenance, document reconciliation, and study closeout activities.
• Conduct or support site visits for CRO oversight and investigator engagement, as needed.

Required Skills

• Minimum of 5 years of clinical trial management experience within the pharmaceutical or biotechnology industry.
• Strong understanding of clinical trial execution, drug development processes, ICH/GCP requirements, and applicable local regulations.
• Demonstrated experience managing CROs, external vendors, and clinical study deliverables.
• Experience coordinating cross-functional clinical study teams and managing competing priorities, timelines, and milestones.
• Strong knowledge of clinical trial documentation, site oversight, protocol compliance, and inspection readiness.
• Excellent written and verbal communication, organizational, time management, and problem-solving skills.
• Ability to exercise sound judgment, resolve conflicts, and proactively address study risks and operational challenges.
• Ability to work independently with limited oversight while collaborating effectively within a matrixed team environment.
• Strong accountability, professionalism, and attention to detail, with a commitment to patient safety and data integrity.

Preferred Skills

• Experience supporting clinical trials in rare disease or orphan indications.
• Experience managing large, complex, or multi-regional clinical studies.
• Familiarity with risk-based quality management, risk-based monitoring, and centralized monitoring approaches.
• Experience supporting site feasibility, investigator engagement, and enrollment planning.
• Experience reviewing clinical study metrics, vendor performance, and contractual deliverables.
• Familiarity with Trial Master File management, database lock activities, and clinical study closeout.
• Bachelor's degree in life sciences, healthcare, or a related field preferred.