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Manager of Clinical Research Trials

2 months 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 company dedicated to enhancing women's health throughout their life stages. Our mission is to uncover unmet medical needs specific to women, rigorously address them through scientific research, and deliver solutions that significantly improve their quality of life. Our initial focus is on gynecological cancers, and our success hinges on the meticulous construction of clinical cohorts within extensive, prospective multi-center clinical trials.

If you are driven by the desire to positively impact patient lives and thrive in a dynamic, interdisciplinary scientific and clinical setting, we invite you to join our team of industry veterans at PinkDx and contribute to a promising and impactful venture.

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 tasked with 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 Leadership: Direct and oversee the Adjudication Process, ensuring compliance with timelines, budgets, and quality benchmarks.
  • Adjudication Management: Organize and supervise the pathology and clinical adjudication process, including the training and oversight of adjudicators to guarantee impartial and precise evaluations 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 pertinent parties.
  • Documentation and Reporting: Draft and review clinical trial documentation, such as protocols, case report forms, informed consent forms, and regulatory submissions. Produce regular progress updates 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).
  • Proven project management skills, with a successful track record in managing complex clinical trials.
  • Attention to detail and the ability to prioritize tasks effectively to meet critical deadlines.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal abilities, with a talent for building and maintaining relationships with diverse stakeholders.
  • Ability to work independently and collaboratively in a fast-paced, dynamic environment.
  • High proficiency in Microsoft Office and collaboration applications.