Director, Development Systems (CTMS & eTMF)

The Director, Development Systems (CTMS & eTMF) at Corcept is primarily responsible for leading the implementation and strategic oversight of the company's Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF). This includes defining user requirements, developing change management strategies, enhancing system integration within clinical operations, and driving continuous improvements through user feedback.

Candidates for the Director, Development Systems (CTMS & eTMF) position at Corcept should possess a bachelor's degree or equivalent and have over 12 years of experience in a pharmaceutical or biotechnology environment. Extensive knowledge of CTMS and eTMF systems, computer systems validation, and a strong grasp of industry regulations are essential for success in this role.

The Director contributes to clinical trials at Corcept by ensuring that the CTMS and eTMF are effectively implemented and aligned with clinical operations. They work closely with various departments to develop streamlined workflows, enhance data management strategies, and ensure compliance with regulatory standards, ultimately improving the efficiency of clinical studies.

Beneficial experience for this role includes a strong background in clinical systems management, especially within the pharmaceutical industry or CROs. Familiarity with leading CTMS and eTMF vendors such as Veeva or Medidata, along with experience in change management and user training, will also be advantageous to successfully navigate the challenges of this position.

At Corcept, the Director, Development Systems (CTMS & eTMF) can expect a dynamic and collaborative environment. This hybrid role typically requires on-site presence three days a week, facilitating direct interaction with cross-functional teams to foster innovation and drive forward the clinical development initiatives of the company.

To implement a new CTMS effectively, I would begin by gathering input from all stakeholders to understand their needs and expectations. Following this, I would develop a comprehensive implementation plan that addresses user requirements and outlines business process flows. Engaging in change management strategies, such as training and ongoing support, would also be essential in maximizing user adoption and effectively integrating the system within clinical operations.

I approach continuous improvement by establishing channels for user feedback and maintaining an ongoing dialogue with internal stakeholders. I believe in fostering a culture of openness, where team members can share challenges and propose enhancements. Utilizing this feedback, I would prioritize system improvements, ensuring they align with the broader organizational goals and contribute to operational efficiency.

Throughout my career, I have extensively worked with CTMS and eTMF systems, including leading implementations and optimizing their performance within clinical operations. I have a strong understanding of how these systems function and interrelate, having managed user training, compliance with regulatory standards, and ensuring data integrity for a range of clinical trials. This hands-on experience allows me to oversee these systems effectively.

To handle data quality issues within a CTMS, I would first identify the root cause by analyzing the workflow and assessing training needs. I would then implement corrective actions, such as refining data entry processes, providing additional user training, or enhancing system validations to prevent future issues. Regular audits and reviews would be conducted to ensure ongoing data integrity and quality.

Communication is vital in the Director, Development Systems position. You must effectively collaborate with various teams, including Clinical Operations, IT, and external vendors. Clearly articulating project goals, changes, and system enhancements ensures alignment and fosters a collaborative environment. Additionally, maintaining open lines of communication with users helps address their needs and promotes user adoption of the systems.

I stay current with industry trends by actively engaging with professional associations, attending seminars, and subscribing to key industry publications. Networking with peers and participating in forums allows me to exchange ideas and discover best practices. Continuous learning is crucial in adapting to the dynamic field of clinical systems management and ensures that I remain well-informed of advancements and regulatory changes.

Important metrics to measure the success of a CTMS include user adoption rates, data quality and integrity, compliance with regulatory standards, and efficiency improvements within clinical workflows. Customer satisfaction feedback from users and stakeholders can also provide valuable insights into how well the system meets the organization's needs.

One challenge I faced was resistance to adopting a new CTMS among some clinical staff. To address this, I implemented a comprehensive change management strategy that included initial training sessions, ongoing support, and creating a user feedback loop to help address concerns. By demonstrating the efficiencies the new system could bring, I was able to foster acceptance and increase user confidence.

I have substantial experience managing cross-functional teams by fostering a collaborative environment where input from diverse functions is valued. I typically emphasize the importance of a shared vision, aligning team goals with organizational objectives while clearly defining roles and responsibilities. This approach has led to successful project outcomes, leveraging our strengths collectively.

In prioritizing projects, I assess each project’s alignment with strategic business objectives, its potential impact on clinical operations, and the resources available. By collaborating with key stakeholders to understand their priorities and discussing timelines, I create a strategic roadmap that balances urgent needs with long-term goals, ensuring the effective and efficient execution of our initiatives.