Clinical Trial Manager (CTM)
Location: Redwood City, CA
- Rezolute is a clinical-stage biopharmaceutical company developing novel therapies for diseases caused by chronic glucose imbalance.
- Rezolute has initiated a global Phase 2b trial in Europe for their lead clinical asset, RZ358, which is a potential treatment for Congenital hyperinsulinism (CHI), an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas.
- The company’s second clinical-stage asset, currently in Phase 1, RZ402, is a selective and potent plasma kallikrein inhibitor (PKI) being developed as a potential oral therapy for the chronic treatment of diabetic macular edema (DME)
- Rezolute has received orphan drug designation in the United States and European Union as well as a rare pediatric disease designation, for RZ358, enabling eligibility for a priority review voucher.
- More information can be found at rezolutebio.com.
The Clinical Trial Manager will report to the Director of Clinical Operations and will lead various operational aspects of the clinical management in collaboration with other clinical team members. Responsible for providing expert and overall support to the clinical study team in matters related to the clinical study documentation, investigational site management and other study related activities, including study start-up, vendor management during the course of the study, interim study management and monitoring as well as trial closeout activities.
Principle Duties and Responsibilities Include
- Manage the day-to-day components of clinical trial under the direction of supervisor
- Ensure assigned deliverables are completed on time, within budget and in compliance with Rezolute SOPs, FDA regulations and ICH/GCP guidelines
- Prepare and lead team meetings internally and with CROs, CRAs and clinical sites
- Work closely with relevant functional areas (preclinical development, CMC, regulatory, clinical development, safety and data management) to accurately coordinate and lead clinical study activities
- Support the identification, evaluation, selection of oversight of clinical trial sites for study conduct
- Develop RFPs, participate in the capabilities review and selection of CROs and other clinical vendors
- Develop trial-related training materials for Rezolute/clinical team members and clinical site staff
- Develop collaborative partnership with study sites and oversee the training of the clinical sites to ensure protocol and regulatory compliance as well as quality and consistency of the data collection
- Perform on-site monitoring activities as needed and provide monitoring oversight by reviewing monitoring schedules, metrics, and reports
- Manage clinical vendors (e.g. CRO, central and specialty labs or specialty vendors, IRB, etc.) to ensure timely and quality study deliverables
- Contribute to the development of key study documents (e.g. protocols, informed consents, case report forms, overall study execution plans, study guides, etc.) and lead system set-up (e.g. UAT of EDC, IRT, Lab Portals, etc.)
- Accurately update and maintain clinical systems within project timelines, coordinate and plan for availability of clinical and non-clinical supplies required for trial execution
- Coordinate, review and finalize the content that will be presented for the Investigator Meetings
- Provide project administrative oversight of the Trial Master File and ensure all study related vendors are contribution to the Trial Master File as required
- Proactively identify and resolve issues that arise during study conduct with investigators, clinical sites, vendors, and internal teams and know when to escalate
- Perform clinical data review at the CRF, data listing and report table levels including interim and database lock as well as in preparation of final study reports
- Assist with invoice review and study budget tracking
- Provide study progress updates with timelines and metric reports.
- As we grow mentor and coach Sr. CRAs, CRAs and Clinical Trial Assistants (CTA’s)
- Perform other duties and assignments as required for overall success of the projects. Duties may change based on the status of clinical programs and ongoing needs of the organization
Qualifications/Requirements - We are looking for a candidate with:
- Bachelor’s degree in a relevant scientific discipline or equivalent
- At least 10 years of experience in managing global clinical trials at all stages of development
- Strong knowledge of GCP, ICH guidelines and GDPR required
- Excellent communication skills with a proven ability to work with various clinical sites
- Demonstrated ability to successfully manage and deliver clinical trials from start-up through close-out including all financial tracking and reporting activities
- Deep understanding of clinical trial design, protocol development and review
- Experience with regulatory inspectors and/or inspection-readiness activities
- Demonstrated successful management of CROs, central labs and other clinical service providers
- Experience in the management and maintenance of EDC, CTMS and a submission-ready eTMF
- Strong collaboration and team orientation, with strong written and verbal communication skills
- Detail and quality oriented with ability to work independently and within a team
- Self-motivated and able to thrive in a fast-paced, small company environment
- Able to solve complex problems, prioritize multiple tasks and plan proactively
- Experience developing tools and processes that increase measured efficiencies of the company
- Strong proficiency with MS Word, Excel, Outlook, and PowerPoint
- Must be willing to travel (25 -30%)
Preferred Experience, Special Skills and Knowledge - We are looking for a candidate that is:
- Start-up biotech with global experience would be a plus
Interested and qualified candidates should send their resume to email@example.com to the attention of Melissa Quinn.