Clinical Operations Manager (Office Based South SF 3Xwk)
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Job Location:
South San Francisco, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
The Clinical Operations Manager is responsible for the oversight and performance management of Clinical Research Associates (CRAs) to ensure high-quality execution of clinical trials in compliance with ICH-GCP SOPs and regulatory requirements. This role serves as the primary operational lead for CRAs and ensures monitoring activities support study timelines data integrity and patient safety.
This hybrid role is based in our South San Francisco CA office.
CRA Management & Oversight
- Provide oversight and direction for the activities of regional or global CRAs to ensure high-quality monitoring
- Assign CRAs to studies based on experience workload and study needs
- Conduct regular 1:1s to review study progress address issues and ensure monitoring activities meet expectations
- Facilitate CRA onboarding training and ongoing guidance
- Review and approve monitoring reports trip reports and follow-up letters as required
- Conduct co-monitoring and/or Sponsor oversight monitoring visits as required
Study Execution & Quality
- Ensure monitoring activities are conducted per protocol the approved monitoring plan ICH-GCP SOPs and applicable regulations
- Identify and proactively address monitoring risks site performance issues and compliance concerns
- Assist Study Manager with the creation and implementation of documents/tools related to study/site monitoring (e.g. Monitoring Plan eligibility checklist slot request forms)
- Partner with study teams to resolve site issues deviations and inspection readiness gaps
- Escalate quality compliance or resourcing risks appropriately
- Operational & Resource Management
- Monitor CRA workload utilization and capacity planning
- Support study start-up enrollment and close-out activities from a monitoring perspective
- Collaborate with Clinical Operations leadership on resourcing strategies and forecasting
- Participate in audit and inspection readiness activities including sponsor and regulatory inspections
Cross-Functional Collaboration
- Work closely with Clinical Trial Managers Project Managers Data Management and Safety teams
- Serve as a point of escalation for site-related and monitoring-related issues
- Provide input into monitoring strategies including risk-based monitoring approaches
Process Improvement
- Contribute to the development and refinement of monitoring SOPs and best practices
- Identify opportunities to improve monitoring efficiency quality and consistency
- Support implementation of new tools systems and training initiatives
- Up to 20% travel depending on study and team needs
Qualifications :
Required
- Bachelors degree in life sciences nursing or a related field with six years clinical research experience of which four years are as a CRA with strong monitoring expertise
- Proven leadership experience in people management or mentoring (direct or matrixed) including coaching and performance management.
Preferred
- Advance degree
- Experience across multiple trial phases therapeutic areas and geographic regions
- Experience with risk-based monitoring models and clinical trial systems (e.g. CTMS eTMF)
- Highly effective communicator with strong presentation problemsolving and organizational skills capable of independently engaging stakeholders and fostering effective relationships within multi-cultural and geographically diverse teams
- Advanced critical reasoning skills including the identification and resolution of a wide-range of complex problems
- Detailed-oriented with the ability to work independently and manage competing priorities with a willingness to learn and adapt to new situations
- Competent in the application of standard business procedures (standard operating procedures (SOPs) International Conference on Harmonization (ICH) Global Regulations Ethics and Compliance).
Additional Information :
The pay range for this position at commencement of employment is expected to be between $145K and $160K/year; however base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and experience. The total compensation package for this position may also include other elements including a sign-on bonus restricted stock units and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.
At Zai Lab we are proud of the gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels 59% of our employees are women and 53% of our management positions are held by women. We are committed to the health of patients and our planet. Thats why our environmental protection social responsibility and corporate governance strategy called Trust for Life is integrated within our business.
Disclaimer: This description is not intended to be construed as an exhaustive list of duties responsibilities or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time as needed.
All qualified applicants will receive consideration for employment without regard to race sex color religion sexual orientation gender identity national origin protected veteran status or based on disability.
Zai Lab is committed to protecting the privacy and security of the information we collect and to being transparent about the purposes for which we use your information. We have a Privacy Notice which sets forth our policies and practices for handling the information we collect and use in the employment context. Privacy Notice available upon request.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Business Development
- Company Policies
- Customer Service
- Financial Performance
- Revenue Growth
- Oversight
- Regional Sales
- Account Management
- Project Management
- Product Line
- Ensure Compliance
- Human Resources
- Procedures
- Sales Goals
- Direct Reports
About Company
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders ... View more
