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Clinical Trial Operations Manager
2 months ago
About PinkDx, Inc.
PinkDx, Inc. is a pioneering healthcare company dedicated to improving the lives of women through innovative medical solutions. Our mission is to identify and address unmet medical needs unique to women, leveraging scientific rigor to provide timely and impactful answers.
Job Summary
We are seeking a highly motivated and experienced Clinical Trial Operations Manager to join our team. As a key member of our clinical operations team, you will be responsible for overseeing and coordinating all aspects of clinical trials, with a focus on ensuring compliance with regulatory requirements and company standards.
Key Responsibilities
- 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.
Requirements
- 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.
