For our client, we are seeking a Senior Manager, Clinical Operations to join the team of a leader in the Pharmaceuticals & Biotech space.
This remote role will provide leadership for clinical operations process governance and help ensure the organization’s workflows remain compliant, efficient, and scalable. The position will serve as a senior subject matter expert across clinical operations, supporting cross-functional decision-making, process improvement, and quality readiness. This individual will also partner with key stakeholders to translate regulatory expectations into practical operating procedures that support global clinical programs.
Location: Remote - US based candidates only, no visa sponsorship available
Compensation: $147,300 – $220,900 annually
Responsibilities
- Serve as the Clinical Process Owner for Clinical Operations, ensuring effective governance and alignment.
- Lead the development and maintenance of Clinical Operations SOPs and documentation.
- Identify and resolve process gaps and complexities for practical workflows.
- Translate regulatory requirements and stakeholder feedback into process solutions.
- Partner with multiple functions for process governance and decision-making.
- Implement change management and assess impacts of new processes.
- Act as a senior Clinical Operations expert for audits, inspections, CAPAs, and strategic initiatives.
Qualifications
- Bachelor's degree in life sciences, healthcare, clinical research, business, or a related field; equivalent experience may be considered.
- 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.
- Strong knowledge of clinical trial operations, clinical monitoring, and site management processes.
- Strong knowledge of ICH-GCP, regulatory expectations, and quality standards.
- Demonstrated ability to influence stakeholders and drive outcomes in a matrix organization.
Benefits
- Health insurance
- Retirement savings benefits
- Life insurance and disability benefits
- Parental leave
- Paid time off for sick leave and vacation
- Discretionary annual bonus
Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.