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Oncology Clinical Operations Leader
2 months ago
Company Overview: Guardant Health is at the forefront of precision oncology, dedicated to combating cancer on a global scale through innovative testing solutions, extensive data analytics, and advanced technological capabilities.
About the Role: As a Clinical Trial Manager, you will oversee the comprehensive execution of clinical studies, including initiation, management, and closure. Your role will involve collaboration across various departments within Guardant Health, such as Bioinformatics, Clinical Operations, Regulatory Affairs, and Client Services, to ensure that study protocols are executed efficiently and in compliance with Good Clinical Practices (GCP).
Key Responsibilities:
- Act as the primary operational liaison for pharmaceutical partners.
- Identify and address challenges to ensure timely and successful study execution, proposing innovative solutions to meet project milestones.
- Evaluate the feasibility of study timelines and partner requirements.
- Coordinate with pharmaceutical partners to establish reporting needs and align with internal teams for report delivery.
- Finalize Data Transfer Agreements (DTA) and Data Transfer Specifications (DTS) as necessary.
- Oversee study monitoring to ensure adherence to the monitoring plan, including planning visits, reviewing reports, and guiding monitoring staff.
- Provide training and ongoing educational support to investigative site personnel to ensure compliance with study protocols and regulatory standards.
- Supervise research sample processing operations.
- Mentor and lead Clinical Research Associates (CRAs).
Qualifications:
- Bachelor's degree or higher in a science or health-related field.
- A minimum of 5 years of clinical trial experience in the Pharmaceutical, Biotech, or CRO sectors, with at least 2 years in direct trial management, preferably with clinical team oversight.
- Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
- Experience in clinical settings, particularly in oncology, is advantageous.
- Familiarity with in vitro diagnostic (IVD) studies and Companion Diagnostic (CDx) trials is highly preferred.
- Experience with real-world data and pragmatic trials is a plus.
- Demonstrated organizational skills and business acumen.
- Proven ability to foster positive relationships with internal and external stakeholders.
- Exceptional problem-solving skills and communication abilities in English.
- Willingness to travel 25%-50% of the time.
- Proficient in MS Office and clinical trial management software.
- A commitment to making a meaningful impact in cancer diagnosis and treatment.
- Detail-oriented with a strong drive to complete tasks effectively.
- Ability to thrive in a fast-paced startup environment, both independently and collaboratively.
Work Environment: Guardant Health promotes a hybrid work model, allowing for a balance between in-office collaboration and remote work. This approach fosters a flexible work-life balance while ensuring teams remain connected and focused on advancing cancer care.
Equal Opportunity Employment: Guardant Health is an Equal Opportunity Employer, committed to diversity and inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status.
