Senior Manager, Clinical Operations
J
JobgetherClinical Operations
Based in United StatesFull-TimeManager
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Experience
- 5+ years
- Required Skills
- Quality AssuranceStakeholder managementChange ManagementProcess improvement
Requirements
- Bachelor’s degree in life sciences, healthcare, clinical research, business, or a related discipline.
- 5+ years of progressive experience in clinical research or Clinical Operations within a CRO, pharmaceutical, biotechnology, or global clinical outsourcing environment.
- Demonstrated experience leading complex, cross-functional, or global process improvement initiatives.
- Strong understanding of clinical trial operations, including clinical monitoring, site management, and cross-functional trial delivery processes.
- Strong knowledge of ICH-GCP, regulatory expectations, quality standards, and inspection-readiness principles.
- Experience developing, harmonizing, implementing, and managing the lifecycle 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 interfaces with other functions.
- Strong stakeholder-management and influencing skills within a matrix organization.
Responsibilities
- Serve as the Clinical Operations Process Owner, establishing effective governance, accountability, lifecycle management, and alignment across regions and functions.
- Lead the development, review, harmonization, implementation, and ongoing maintenance of Clinical Operations SOPs, work instructions, tools, templates, and controlled documentation.
- Identify process gaps, duplication, inconsistencies, conflicting requirements, and unnecessary complexity, translating findings into clear, practical, and scalable solutions.
- Interpret regulatory requirements, ICH-GCP principles, quality standards, audit and inspection findings, CAPAs, operational data, and stakeholder feedback to improve Clinical Operations processes.
- Lead cross-functional process governance and facilitate decision-making in partnership with Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other relevant teams.
- Lead process implementation and change management activities, including impact assessments, stakeholder engagement, communications, training requirements, adoption monitoring, and effectiveness evaluation.
- Provide Clinical Operations process expertise for business development activities, including proposals, budgets, contracts, bid-defense meetings, and discussions with prospective clients.
View Full Description & ApplyYou'll be redirected to the employer's site
