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Senior Manager, Clinical Operations (Contractor)
Aurinia PharmaceuticalsUnited States, United Statesfull_timeVerifiedPosted 16 Apr 2025
About the role
Our Mission: Changing the trajectory of autoimmune diseases.Our Vision: Enabling patients to live their fullest life.We are a dedicated team of experts committed to changing the trajectory of autoimmune diseases with unmet medical needs. We are relentless in our pursuit to provide transformative medical treatments. We are resilient. We Care. Along with driving adoption of our approved therapy, LUPKYNIS™, for appropriate people with lupus nephritis, we are pursuing a broader portfolio of innovative autoimmune disease therapies. We provide high quality products to our patients, that are safe and effective. Each of us at Aurinia own Quality, and we proactively integrate Quality into everything that we do. Exceptional quality and regulatory compliance are essential to our business, and “We Care” so that patients can take our drugs with confidence. Our strategy leverages the skills and knowledge of our expert team and our deep experience in principled drug development and commercialization. Aurinia’s working environment enables every individual to thrive in a professional atmosphere guided by our Culture Values:
Responsible for management of Clinical Operations process development and improvement, management of clinical trials and collaboration with cross functional colleagues to enhance organizational efficiency. Additional responsibilities include but are not limited to staffing, budgeting, training, developing needed SOPs, vendor (including CROs) oversight. This individual will work closely with representatives across the organization and with multiple external vendors to manage clinical trials and enhance operational efficiency. Responsibilities:
- Achieve together
- Collaborate
- Explore & build
- Act responsibly
Responsible for management of Clinical Operations process development and improvement, management of clinical trials and collaboration with cross functional colleagues to enhance organizational efficiency. Additional responsibilities include but are not limited to staffing, budgeting, training, developing needed SOPs, vendor (including CROs) oversight. This individual will work closely with representatives across the organization and with multiple external vendors to manage clinical trials and enhance operational efficiency. Responsibilities:
- Drive continuous quality improvement initiatives through engagement with end users and ensure compliance with departmental standards and processes
- Work with Clinical Operations and cross functional team members to identify areas for process improvement. This includes but is not limited to template development, SOP writing and enhancement, creation of new tools and implementation of new systems to meet departmental or corporate objectives
- Oversee outsourced CRA team
- Work with project teams to identify resource needs
- Create standard training processes for CRA on and off boarding
- Engage with CRA vendor management teams to plan future CRA sourcing needs
- Participate in performance management discussions with CRA vendors
- Includes evaluation of KPIs within and across projects, personnel management and issue resolution and other issues as needed
- Develop / refine departmental career paths
- Participate in mentoring junior team members
- Oversee/manage CROs including:
- Ensuring consistent approach to CRO set-up across all studies
- In collaboration with project teams, review CRO Key Performance Indicators and milestones delivery
- In cooperation with Clinical Operations Systems Management team ensure that TMF metrics are met eTMF is compliant and consistent with corporate standards and GCP/ICH guidelines
- Oversee monitoring activities under MG management and ensure ClinOps adherence to SOPs related to monitoring activities
- Maintain awareness of overall developments and benchmarks in Clinical Operations
- Lead the design, documentation, implementation and management of new state of the art, systems to ensure maximum efficiency
- Performs other functions as necessary or as assigned
- Trial management
- Bachelor’s Degree, preferably in health care or life sciences or equivalent experience.
- 8-10 years of Clinical Operations experienc
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