Senior Manager, Clinical Operations – Clinical Process Owner
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Senior Manager governing and improving clinical operations processes, SOPs, and quality systems. Supporting global clinical research services for new therapeutics at Precision for Medicine.
Responsibilities:
- Serve as the Clinical Process Owner for Clinical Operations processes, ensuring effective governance, clear accountability, lifecycle management, and alignment across regions and functions
- Lead the development, review, harmonization, implementation, and maintenance of Clinical Operations SOPs, work instructions, tools, templates, and related documentation
- Identify and resolve process gaps, duplication, inconsistencies, conflicting requirements, and unnecessary complexity
- Translate regulatory requirements, ICH-GCP principles, quality standards, audit and inspection findings, CAPAs, operational data, and stakeholder feedback into effective process solutions
- Lead and represent cross-functional process governance and decision-making with Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other functions
- Lead process implementation and change management, including impact assessment, stakeholder engagement, training and communication requirements, adoption monitoring, and evaluation of process effectiveness
- Act as a senior Clinical Operations SME for strategic initiatives, audits, inspections, CAPAs, process assessments, operational improvement activities, and business development support
- Provide Clinical Operations input for proposals, budgets, contracts, and bid defense meetings, and represent Clinical Operations process capabilities to prospective clients
- Lead cross-functional working groups, process teams, and strategic improvement initiatives as needed
Requirements:
- Bachelor’s degree in life sciences, healthcare, clinical research, business, or a related field; equivalent experience may be considered
- At least 5+ years of progressive clinical research or clinical operations experience in a CRO, pharmaceutical, biotechnology, or global clinical outsourcing environment
- Proven experience leading complex cross-functional or global process improvement initiatives from assessment and design through implementation and effectiveness evaluation within a CRO environment
- Strong knowledge of clinical trial operations, clinical monitoring, site management, and cross-functional trial delivery processes
- Strong knowledge of ICH-GCP, regulatory expectations, quality standards, and inspection readiness principles
- Demonstrated ability to influence stakeholders, facilitate decisions, resolve conflicting requirements, and drive outcomes in a matrix organization
- Demonstrated experience owning or leading the development, harmonization, implementation, and lifecycle management of Clinical Operations SOPs, work instructions, and related controlled documentation
- Experience with process mapping, change management, Lean, or continuous improvement methodologies
- Expert understanding of Clinical Operations processes and their cross-functional interfaces
- Ability to interpret regulatory and quality requirements and translate them into clear, proportionate, and operationally practical processes
Similar Jobs
Senior Manager, Clinical Operations – Clinical Process Owner
Senior Manager owning Clinical Operations processes, SOPs, and governance at a global precision medicine research organization. Driving compliant, scalable process improvement across clinical research functions.
Director, Clinical Development Operations
Director leading clinical development operations, process optimization, and global project management systems at Syneos Health. Supporting drug development and commercialization through integrated life sciences services.
Associate Director, Clinical Operations
Associate Director leading global clinical trial execution for Kite, a biopharmaceutical company developing CAR T-cell cancer immunotherapies. Managing programs, CROs, budgets, timelines, and Clinical Operations teams.
Senior Manager, Clinical Quality Assurance
Senior Manager overseeing clinical quality assurance for Elevar Therapeutics’ biotech clinical trials. Ensuring GCP compliance, audit readiness, regulatory submissions, and inspection preparedness.
Clinical Program Advisor – Clinical Operations
Clinical pharmacy advisor guiding Medicare benefit programs for Evernorth, which creates pharmacy, care, and benefit solutions. Advising clients, sales teams, and internal stakeholders on clinical operations and implementation.
Senior Clinical Project Manager – Single Sponsor, Global Experience
Senior Clinical Project Manager leading multinational clinical trials for Syneos Health, a life sciences services organization. Managing documents, sites, vendors, timelines, budgets, and risk mitigation.
Global Clinical Project Manager II
Clinical project manager supporting late-phase hematology and immunology trials for Syneos Health, a global life sciences services organization. Managing vendors, trial documents, timelines, and consent templates.
Single Sponsor Clinical Project Manager II – Global experience needed
Clinical project manager supporting global late-phase Hematology and Immunology trials at Syneos Health. Managing CROs, vendors, trial documents, and study timelines.
Director, Clinical Operations
Clinical operations director leading clinical trials, regulatory compliance, and team capability at ICON, a global healthcare intelligence and clinical research organisation.
Clinical Operations Manager
Clinical Operations Manager leading clinical operations staff and monitoring quality for Indero, a dermatology-focused contract research organization. Driving compliant study execution, team development, and workflow innovation.
Clinical Operations Manager
Clinical Operations Manager overseeing teams, monitoring quality, training, and trial execution at Indero, a dermatology-focused contract research organization. Driving operational efficiency, compliance, and innovation across clinical studies.
Respiratory Clinical Program Manager
Respiratory clinical program manager guiding McKesson’s healthcare respiratory solutions. Delivering clinical education, customer consultation, and program leadership across respiratory therapies and equipment.
Clinical Operations Analyst
Clinical Operations Analyst improving clinical workflows and reporting for Liberty Dental Plan, a healthcare organization. Delivering analytics, process improvements, and project coordination for clinical leadership.
Clinical Operations Strategy Lead – Practice Implementation
Clinical operations lead onboarding partner practices to CenterWell’s EHR, data-sharing, and population health tools. Driving value-based care adoption and optimized senior healthcare delivery.
Associate Director, Clinical Operations – FSP
Associate Director leading clinical operations for Thermo Fisher’s PPD FSP CRO services. Managing clinical teams, deliverables, resources, budgets, and global project performance.
Clinical Study Operations Associate
Clinical study operations associate supporting Beacon Biosignals’ at-home EEG platform for neurological, psychiatric, and sleep-disorder trials. Managing study startup, clinical sites, device training, monitoring, and regulatory compliance remotely across the U.S.
Vice President, Population Health – Clinical Operations
Centene executive leading Missouri population health strategy and clinical operations. Driving analytics, utilization management, quality initiatives, contracts, and member health outcomes.
Project Manager – Clinical Trial Lead
Clinical Trial Lead managing global clinical studies for Syneos Health, a life sciences services organization. Leading project delivery, compliance, budgets, timelines, and client coordination.
Clinical Program Manager
Maximus Clinical Program Manager leading Ohio PASRR human services operations and state-client relationships. Overseeing staff, compliance, financial performance, clinical documentation, and service delivery improvements.
Clinical Project Manager
Clinical Project Manager leading US clinical projects for ICON, a global clinical research organization. Coordinating timelines, budgets, risks, stakeholders, and cross-functional teams.