Senior Manager, Clinical Operations
New
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Precision for MedicineClinical Research
Remote, CanadaFull-TimeManager
Salary147,300 - 220,900 USD
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Job Details
- Experience
- 5+ years
- Required Skills
- Quality AssuranceStakeholder managementChange ManagementProcess improvement
Requirements
- Bachelor’s degree in life sciences, healthcare, clinical research, business, or related field.
- 5+ years of progressive clinical research or clinical operations experience in a CRO, pharmaceutical, or biotechnology environment.
- Proven experience leading complex cross-functional or global process improvement initiatives.
- Strong knowledge of clinical trial operations, monitoring, and site management.
- Expert knowledge of ICH-GCP, regulatory expectations, and quality standards.
- Demonstrated ability to influence stakeholders, facilitate decisions, and drive outcomes in a matrix organization.
- Experience with process mapping and change management methodologies preferred.
- Ability to interpret and translate quality/regulatory requirements into practical processes.
Responsibilities
- Serve as the Clinical Process Owner for Clinical Operations processes, ensuring effective governance and lifecycle management.
- Lead the development, review, harmonization, and maintenance of SOPs, work instructions, tools, and templates.
- Identify and resolve process gaps, inconsistencies, and conflicting requirements to improve scalability.
- Translate regulatory requirements, ICH-GCP principles, and quality standards into effective process solutions.
- Lead cross-functional process governance and collaborate with Quality Assurance, Regulatory, and Project Management teams.
- Manage process implementation and change management, including stakeholder engagement and training.
- Act as a subject matter expert for strategic initiatives, audits, inspections, and business development support.
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