Clinical Trials Operations Manager

2 weeks ago

Daly City, California, United States PinkDx, Inc. Full time

Job Title: Clinical Trial Manager

Location: San Francisco Bay Area

Job Type: Full-Time

About PinkDx, Inc.:

PinkDx is an innovative organization dedicated to enhancing women's health throughout their life stages. Our mission is to identify and address unique medical needs of women with scientific precision, aiming to deliver solutions that have a meaningful and immediate impact on their well-being. Our primary focus is on gynecological cancers, and our success hinges on the quality and rigor with which we establish clinical cohorts in extensive, prospective multi-center clinical trials.

If you are driven by the desire to make a significant difference in patients' lives and possess the ability to thrive in a dynamic, interdisciplinary scientific and clinical setting, we invite you to join the seasoned professionals who founded PinkDx and be part of an exciting and impactful journey.

Position Overview:

We are in search of a highly skilled and motivated Clinical Trial Manager with a robust background in project management and experience overseeing the adjudication process for determining diagnostic truth labels within clinical cohorts. The ideal candidate will be responsible for managing and coordinating all facets of clinical trials, with a specific emphasis on the adjudication process, ensuring adherence to regulatory standards and company protocols.

Key Responsibilities:

  • Project Management: Lead and oversee the Adjudication Process, ensuring compliance with timelines, budgets, and quality benchmarks.
  • Adjudication Process Management: Coordinate and supervise the pathology and clinical adjudication process, including the training and oversight of adjudicators to guarantee unbiased and precise evaluation of clinical trial data.
  • Stakeholder Engagement: Act as the primary liaison for both internal and external stakeholders, including clinical trial sites, investigators, adjudicators, and other relevant parties.
  • Documentation and Reporting: Prepare and review clinical trial documentation, such as protocols, case report forms, informed consent forms, and regulatory submissions. Generate regular progress reports for stakeholders.
  • Risk Assessment: Identify potential risks and formulate mitigation strategies to ensure the successful execution of projects.
  • Continuous Improvement: Remain informed about industry trends and best practices, consistently seeking opportunities to enhance clinical trial processes and outcomes.

Qualifications:

  • Bachelor's degree in a relevant discipline (e.g., life sciences, healthcare, project management).
  • Work experience may be considered in lieu of a Bachelor's degree.
  • A minimum of 4 years of experience in clinical trial management.
  • Experience in managing the clinical adjudication process is essential.
  • Experience with pathology slides and diagnostics is highly desirable.
  • Strong understanding of regulatory requirements and guidelines (e.g., ICH-GCP, FDA).
  • Exceptional project management skills, with a proven history of managing complex clinical trials.
  • Meticulous attention to detail and the ability to prioritize tasks to meet critical deadlines.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal abilities, with the capacity to build and maintain relationships with diverse stakeholders.
  • Ability to work independently and collaboratively in a fast-paced, dynamic environment.
  • High proficiency in Microsoft Office and company collaboration tools.

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