Senior Clinical Trial Manager

The Senior Clinical Trial Manager at Natera is responsible for managing the entire lifecycle of clinical trials, including planning, execution, and close-out. This role involves driving timelines, costs, and quality metrics while ensuring compliance with protocols and regulatory standards. The Sr. CTM also manages vendor selection and interactions, oversees budgeting and contracting for clinical trial vendors, and leads internal and external meetings to ensure successful study conduct.

To qualify for the Senior Clinical Trial Manager position at Natera, candidates should possess a Bachelor's Degree or equivalent, with a preference for candidates holding a PMP certification. Additionally, applicants should have over 7 years of relevant clinical research experience in diagnostics, pharmaceuticals, or biotech, coupled with oncology clinical trial experience being highly desired.

At Natera, we value the growth of our team members, particularly in the Senior Clinical Trial Manager role. Employees are encouraged to engage in mentorship opportunities and contribute to cultivating a learning environment. Our collaborative culture allows you to work with highly skilled professionals across various disciplines, offering extensive hands-on experience and continued education through formal training programs.

As a Senior Clinical Trial Manager at Natera, you will handle very complex clinical studies primarily within the oncology field. This includes overseeing operational aspects such as study design, data management, vendor interactions, and ensuring adherence to Good Clinical Practice (GCP). Your expertise will be invaluable in driving successful results that align with Natera’s innovative approach to genetic testing.

Natera seeks a Senior Clinical Trial Manager who demonstrates strong leadership and project management skills, along with the ability to work independently. Ideal candidates are adept communicators, capable of presenting complex information clearly to both internal teams and external partners. Additionally, the ability to problem-solve creatively and a commitment to fostering a collaborative environment are essential qualities for this role.

When answering this question, focus on specific trials you've managed, detailing the phases, challenges faced, and how you navigated them. Highlight your project management skills, budget handling, and compliance with protocols to showcase your fit for the Senior Clinical Trial Manager role at Natera.

It’s crucial to demonstrate your knowledge of regulatory guidelines such as GCP. Discuss your process for reviewing trial protocols, training staff on compliance, and routine audits of study activities to ensure that all aspects of the trials are conducted reliably and ethically.

Use the STAR method (Situation, Task, Action, Result) to outline the challenge clearly. Emphasize your problem-solving skills and the positive outcome that resulted from your actions, making sure to connect how it relates to the leadership qualities necessary for a Senior Clinical Trial Manager at Natera.

Your answer should cover your approach to selection, communication, and ongoing management of vendors and CROs. Discuss how you establish clear expectations and metrics for performance, and how you resolve conflicts or issues swiftly to maintain a productive partnership.

Highlight your experience with budgeting tools or methodologies, specifying your approach to forecasting costs, tracking expenses, and ensuring projects remain financially viable. Make sure to relate this to the expectations of the Senior Clinical Trial Manager at Natera.

Explain how you have taken on mentorship roles in previous positions, providing examples of how you helped junior colleagues grow and improve in their roles. Emphasize the importance of mentoring in fostering a collaborative environment within Natera.

Discuss your experience working with teams beyond clinical operations, such as data management or medical affairs. Focus on specific projects where successful collaboration led to improved outcomes, emphasizing skills in communication and coordination.

Candidates should describe a methodical approach to conflict resolution, which includes open communication, active listening, and mediation techniques. Essential traits for a Senior Clinical Trial Manager, such as diplomacy and the ability to remain objective, should be highlighted.

Mention any relevant journals, conferences, or online platforms you follow to stay updated. This demonstrates your commitment to continuous learning, a key quality sought by Natera for their Senior Clinical Trial Manager role.

Share your passion for clinical research, how it drives you to improve patient outcomes, and specifically how your motivations align with Natera's mission to transform the management of genetic diseases. Personal connections to the role will leave a lasting impression.