Clinical Trial Manager
Company: Rezolute, Inc.
Location: Redwood City
Posted on: January 17, 2023
Job Description:
Position DescriptionThe 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 trials 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) and continuously foster a team environment
- 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
Candidate ProfileQualifications/Requirements:
- 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:
- Start-up biotech with global experience would be a plus
Keywords: Rezolute, Inc., Redwood City , Clinical Trial Manager, Healthcare , Redwood City, California
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