Clinical Trial Manager

1 month ago

Daly City, United States PinkDx, Inc. Full time

Job Title: Clinical Trial Manager 

Location: San Francisco Bay Area 

Job Type: Full-Time


About Us:

PinkDx is an early-stage company focused on positively impacting the health of women throughout their life journey. Our vision is to identify unmet medical needs that are unique to women, address them with scientific rigor, and provide answers that have an immediate, positive impact on their lives. Our initial focus is gynecological cancers. Our success depends on the quality and rigor we use building clinical cohorts in large, prospective multi-center clinical trials.  

If you are passionate about making a difference in the lives of patients and have the capacity to work in a fast-paced, highly interdisciplinary scientific and clinical environment, come join the industry veterans who co-founded PinkDx and get in on the ground floor of what promises to be an exciting, impactful company. 


Position Summary:

We are seeking a highly motivated and experienced Clinical Trial Manager with a strong project management background and experience managing the adjudication process for concluding diagnostic truth labels for the clinical cohort. The successful candidate will be responsible for overseeing and coordinating all aspects of clinical trials, with a particular focus on the adjudication process, ensuring compliance with regulatory requirements and company standards.


Essential Functions: 

  • Project Management: Lead and manage the Adjudication Process, ensuring adherence to timelines, budgets, and quality standards.
  • Adjudication Process Oversight: Coordinate and manage the pathology and clinical adjudication process, including the training and management of adjudicators, ensuring unbiased and accurate assessment of clinical trial data.
  • Stakeholder Coordination: Serve as the primary point of contact for internal and external stakeholders, including clinical trial sites, investigators, adjudicators, and other relevant parties.
  • Documentation and Reporting: Prepare and review clinical trial documentation, including protocols, case report forms, informed consent forms, and regulatory submissions. Generate regular progress reports for stakeholders.
  • Risk Management: Identify potential risks and develop mitigation strategies to ensure the successful execution of projects.
  • Continuous Improvement: Stay current with industry trends and best practices, continuously seeking opportunities to improve clinical trial processes and outcomes.


Education & Experience:

  • Bachelor's degree in a relevant field (e.g., life sciences, healthcare, project management). 
  • Years of work experience may substitute for the Bachelor’s degree. 
  • Minimum of 4 years of experience in clinical trial management 
  • Experience managing the clinical adjudication process is required.
  • Highly desirable for a candidate to have experience with pathology slides and diagnostics. 
  • Strong knowledge of regulatory requirements and guidelines (e.g., ICH-GCP, FDA).
  • Excellent project management skills, with a proven track record of managing complex clinical trials.
  • Attention to detail and ability to prioritize tasks to meet critical deadlines.
  • Strong analytical and problem-solving abilities.
  • Excellent communication and interpersonal skills, with the ability to build and maintain relationships with diverse stakeholders.
  • Ability to work independently and as part of a team in a fast-paced, dynamic environment.
  • High proficiency with Microsoft Office and company collaboration applications.

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