Clinical Project Manager
Jobot Irvine, CA
- Posted: over a month ago
- $100,000 to $140,000 Yearly
This Jobot Job is hosted by: Eric Shaner
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $100,000 - $140,000 per year
A bit about us:
Are you looking for a company that makes an impact? How about equity in a very fast growing company?
Located in the Irvine, CA area (REMOTE to start), we are a fast-growing biopharma company, built on a culture of kindness and helping the greater good seeking a talented Clinical Project Manager. Become part of a team dedicated to supporting the development of ground-breaking drugs. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying an extremely competitive total compensation and benefits package and internal growth opportunities.
Why join us?
- Competitive Base Salary! $90,000 - $130,000
- Extremely Competitive Benefits Package!
- 100% paid medical for employee and dependents!!
- Tons of PTO!
- Flexible Work Schedules!
- Accelerated Career Growth!
Proactively manage project level operational aspects of Clinical Trial Team (CTT) including management of trial timeline, budget, resources and vendors.
Provide efficient updates on trial progress to the Clinical Program Director (CPD) and/or Senior Director of Clinical Operations (DCO), with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial.
Agreements and budgets.
Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
Ensure potential study risks are escalated
Chair working group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed
Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team.
Bachelor’s degree in Life Sciences, Nursing Licensure or Pharmacy, at minimum.
Four or more years of clinical operations experience for CPM; with increasing levels of responsibility, in the Pharmaceutical, Biotechnology, Medical Device or CRO industry is required.
Five or more years of clinical project management experience at a sponsor or CRO company is preferred for CPM.
Experience in early phase trials (Phase I-II) and First-In-Man trials.
Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods.
Travel to sites when necessary.
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