The O'Connor Group

Clinical Operations

• Providing leadership and support as it pertains to the operation of toxicology, ADME-PK, and bioanalysis
• QCs on non-clinical study (GLP or non-GLP) protocols and reports, and study record and study material management constitute a great portion of this role
• Track study milestones and deliverables for internal reporting and management
• Serve as a primary liaison among nonclinical team, legal and finance to facilitate contract placement and execution promptly
• Track invoices and ensure timely payment in coordination with the finance group
• Support budget tracking and forecasting for all relevant studies
• Assist with literature research, and regulatory and submission readiness support as needed
• Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Manager, Nonclinical Operations

• Develop and implement clinical operations strategies to support the company's product pipeline, ensuring alignment with corporate goals and objectives
• Lead and oversee the strategic planning, implementation and execution of clinical trials in accordance with project timelines, budget, and quality standards
• Develop and manage comprehensive site management plans, including but not limited to, study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategies
• Collaborate cross functionally with internal teams to ensure the alignment on clinical trial objectives and milestones and the successful execution and monitoring of clinical trials
• Serve as the point of contact for CROs and vendors, overseeing their site management performance and ensuring adherence to contractual agreements, timelines and quality standards
• Track accrued site operations and monitoring expenditure against the actual budget for each program
• Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct
• Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity
• In collaboration with the Head of Clinical Operations, hire, train, develop, and mentor the Clinical Operations/Clinical Research Associate team, fostering a culture of collaboration, accountability, continues improvement, and operational excellence
• Identify and solve problems that may arise during the trial
• Continuously evaluate and improve clinical trial processes

Director, Clinical Operations

• Lead operational contact for clinical studies
• Provide strategic and operational leadership to the clinical operations team
• Ensure project milestones delivery on time, within budget, high quality, and in compliance
• Responsible for all operational aspects, strategic input, and progress of clinical trial
• Manage vendor activities to support clinical studies
• Oversee study timelines and budget planning
• Participate in country and site feasibility/selection process
• Ensure studies are 'inspection ready' at all times
• Create and foster strong strategic partnerships with colleagues

Manager, Nonclinical Operations

Director, Clinical Operations

Senior Manager – Clinical Operations