Clinical Operations

• Develop and maintain project plans, timelines, budgets, and risk management strategies for assigned clinical trials
• Manage day-to-day trial operations across start-up, enrollment, monitoring, and close-out
• Serve as liaison between sponsors, CROs, investigators, IRBs/ECs, and internal stakeholders
• Oversee site selection, activation, and performance
• Monitor trial budgets, forecast expenditures, and manage vendor/CRO contracts and deliverables
• Ensure compliance with ICH-GCP, FDA/EMA regulations, and applicable local laws
• Track and report enrollment, data quality, and milestone progress
• Identify, assess, and mitigate risks and issues affecting timelines, budget, or quality
• Coordinate with Data Management, Biostatistics, Regulatory Affairs, and Pharmacovigilance teams
• Manage clinical trial documentation, including the Trial Master File, and ensure inspection readiness
• Lead internal team meetings, sponsor calls, and investigator meetings
• Support audits and regulatory inspections as needed
• Uphold the organization’s mission, values, and commitment to ethical research
• Work with patients, research participants, clinical staff, investigators, sponsors, monitors, and community partners

Project Manager – Clinical Trials

• Prepare and/or review study-related and essential study start-up documents for assigned clinical trials
• Serve as Clinical Project Manager and ensure Study Management teams meet study timelines and deliverables
• Oversee and lead study-specific study management resources
• Develop and manage groups of studies for a business unit or large development program
• Mentor other Clinical Project Managers
• Provide critical thinking and leadership during clinical study execution issues
• Write protocols, clinical study reports, and other clinical study deliverables
• Lead or contribute to continuous improvement initiatives
• Manage relationships with sites, principal investigators, CROs, and other study-related vendors
• Develop and maintain integrated project plans and facilitate project meetings
• Define, track, and report schedules, interdependencies, achievements, critical paths, and deliverables
• Adapt work package deliverables based on study scale and complexity
• Create resource and budget forecasts and timelines
• Direct cross-functional team members and vendors on technical, protocol-specific, and operational study aspects
• Identify and manage project risks and issues, including mitigations and contingencies
• Maintain high-quality standards and compliance requirements
• Perform other assigned duties

Clinical Operations jobs in New Jersey

Project Manager – Clinical Trials

Senior Clinical Project Manager