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Clinical Operations Senior Manager

2 months ago

Sunnyvale, California, United States Mcure Biosciences Full time
Job Overview

Position Title: Clinical Operations Senior Manager (Clinical Trials)

Company: Mcure Biosciences Inc.

About Us: We are an innovative startup focused on advancing healthcare solutions. Our team is dedicated to conducting pivotal clinical trials and is looking for a skilled Clinical Operations Senior Manager to contribute to our mission.

Role Summary: The Clinical Operations Senior Manager will be instrumental in the oversight and administration of our forthcoming clinical trials. The ideal candidate will possess substantial expertise in monoclonal antibody studies, with experience in both domestic and international settings. Familiarity with intensive care unit (ICU) operations and trials related to infectious diseases is highly advantageous.

Core Responsibilities:

  • Direct the strategic planning, implementation, and management of clinical trials.
  • Guarantee adherence to regulatory standards and clinical trial protocols.
  • Collaborate effectively with multidisciplinary teams, including Contract Research Organizations (CROs), medical professionals, regulatory bodies, and quality assurance teams.
  • Oversee trial sites, encompassing selection, initiation, and ongoing monitoring.
  • Formulate and uphold study timelines, financial plans, and resource allocations.
  • Prepare and submit necessary regulatory documentation and reports.
  • Ensure the integrity and quality of data throughout the trial process.
  • Manage relationships with external vendors and stakeholders.

Required Qualifications:

  • Bachelor's degree in a relevant discipline.
  • Demonstrated experience in clinical operations, particularly with monoclonal antibody trials.
  • Experience in ICU settings and infectious disease trials is highly desirable.
  • In-depth knowledge of FDA regulations and ICH-GCP guidelines.
  • Exceptional project management and organizational capabilities.
  • Ability to work autonomously and collaboratively in a dynamic environment.
  • Strong communication and interpersonal skills.