Manager, Clinical Safety Operations

The Manager of Clinical Safety Operations at Corcept holds critical responsibilities that include overseeing the drug safety service providers to ensure compliance with global regulatory requirements, managing adverse event reports, and ensuring the clinical trial master file is maintained in an inspection-ready state. The role also involves creating and revising standard operating procedures and implementing safety management plans, making it essential for maintaining high safety standards during clinical trials.

Applicants for the Manager of Clinical Safety Operations position at Corcept should possess a Bachelor’s degree in healthcare or life sciences, such as RN, BSN, or PharmD. Additionally, candidates should have a minimum of 5 years of experience in Drug Safety or pharmacovigilance within a global setting. Familiarity with FDA, EU, and ICH guidelines for safety reporting is also crucial for success in this role.

The Manager of Clinical Safety Operations plays a vital role in advancing Corcept’s mission to improve patient outcomes by ensuring that all safety reporting processes are established and maintained during clinical trials. By closely overseeing pharmacovigilance activities, this role ensures compliance with regulations, supports the development of innovative cortisol modulators, and ultimately contributes to transforming the way serious diseases are treated.

The Manager of Clinical Safety Operations position offers flexibility, allowing candidates to choose a remote work setting or a hybrid role at Corcept's Redwood City office. However, the role requires some travel (up to 20%) as needed to support business requirements, ensuring a balance between remote and on-site engagement.

Candidates applying for the Manager of Clinical Safety Operations position at Corcept should have knowledge of Argus or similar safety applications, electronic data capture systems, and coding dictionaries like MedDRA and WHO Drug. These technical proficiencies are essential for managing and reporting adverse events effectively in compliance with regulatory standards.

When answering this question, focus on specific roles and responsibilities you've held in drug safety. Highlight your experience with collecting and managing adverse event reports, your familiarity with regulatory standards, and any specific projects that demonstrate your knowledge of drug safety operations.

To effectively address this, you should explain your understanding of various regulatory frameworks, such as FDA and ICH guidelines, and how you've implemented those in past roles. Discuss any specific processes you’ve established or maintained to ensure adherence to these requirements.

When responding, talk about your organizational skills, time management techniques, and any tools you use for project tracking. Provide examples of how you've successfully juggled multiple priorities while maintaining high standards of safety and compliance.

Share a specific example that showcases your problem-solving skills and commitment to safety. Discuss what prompted the improvement, the actions you took, and the positive outcomes that resulted from the changes you implemented.

Discuss your approach to creating training materials, your style of presenting information, and how you tailor your content to different audiences. A strong answer will reflect your ability to convey complex information clearly and engage participants effectively.

Here, you should outline your experience preparing for audits, participating in inspections, and your role in ensuring compliance. Focus on the steps you’ve taken to keep documentation inspection-ready and any lessons learned from past experiences.

Highlight the importance of working in multidisciplinary teams and how collaboration enhances patient safety and operational efficiency. Provide examples of how you’ve successfully collaborated with others to achieve common goals in drug safety.

Express your passion for patient safety and how being part of an innovative organization like Corcept drives your commitment to improving treatments. Talk about the satisfaction you gain from contributing to projects that ultimately enhance patient health outcomes.

Discuss your strategies for continuing education, such as attending conferences, enrolling in online courses, reading industry publications, and networking with peers in the field. This will demonstrate your commitment to professional development in the field of drug safety.

Emphasize the importance of data integrity in safety operations and describe your methods for ensuring accurate reporting. Discuss any tools or systems you use to track data and how you’ve trained others on best practices.