Clinical Operations Manager

Spiral Therapeutics is looking for an energetic, hands-on, and analytical Clinical Operations Manager to help us advance our clinical programs to prevent and treat hearing loss.


The Opportunity 

As Spiral’s Clinical Operations Manager, you will work closely with internal and external stakeholders to ensure the successful, cost-effective, and timely execution of Spiral’s clinical research programs.

You will liaise with the rest of our Clinical Development team, Legal and Finance and will be responsible for consistent management of the external expenses and timing related to the implementation of clinical programs.

Tasks and Responsibilities

  • Create, manage and report clinical assumptions and timelines.
  • Negotiate contracts with, and manage CROs, clinical sites and other providers.
  • Work closely with Finance on modeling, budgeting, forecasting and tracking of clinical plans.
  • Work closely with Legal to execute contracts and change orders and purchase orders.
  • Promote effective communication and transparency and act as central point of contact for CROs, clinical sites and other service providers.

Requirements

  • BS/MS degree in a scientific or healthcare discipline required.
  • Experience in clinical trials (CNS, Ophthalmology, Otology or Orphan) is a plus.
  • 5+ years of industry experience, 3+ years of clinical experience.
  • Deep understanding of the drug development process and the cross-functional responsibilities including: clinical trial design, study start-up and execution, CRA and site management, safety reporting, data management, biometrics and regulatory strategy.
  • Strong analytical and project management skills.
  • Well organized and self-directed.

Location

Brisbane, CA

Applicants should send portfolio, cover letter and LinkedIn (or resume) to info@spiraltx.com with the reference “Clinical Operations Manager” on the subject.

Spiral Therapeutics believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.

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