Director, Development Systems (CTMS & eTMF)

About the position

The Director, Development Systems (CTMS & eTMF) is responsible for the strategic oversight and day-to-day operations of Corcept’s pending Clinical Trial Management System (CTMS) that will be used to manage the company’s clinical studies and existing electronic Trial Master File (eTMF) system that is used to store, organize, and manage essential documents related to the company’s clinical trials. This role is key to shaping the systems that support the company’s clinical trials and ensures that both systems align with broader organizational goals. Reporting to the Head of Development Operations, the Director partners closely with leaders in Clinical Operations and IT, and their respective departments. This is a hybrid role typically requiring on-site presence 3 days per week.

Responsibilities

• Work in close collaboration with Clinical Operations, IT, and our CTMS vendor, lead the implementation of the company’s first in-house instance of CTMS, including defining the intended use of the system, business process flows, and user requirements, and the continued evolution of the company’s eTMF.
• Develop and execute change management strategies to maximize adoption and ensure seamless integration of CTMS and eTMF systems within clinical operations.
• Drive continuous improvement by establishing a community of internal CTMS and eTMF users, collecting feedback, and identifying system enhancements that optimize business processes and user experience.
• Partner with the Head of Business Relationship Management (IT) to co-create and maintain a 3-year roadmap for CTMS and eTMF system enhancements, ensuring alignment with Corcept’s strategic objectives and technology evolution.
• Influence cross-functional teams (Clinical Operations, Clinical Records, and IT) to establish and implement effective data management strategies for how the information contained in CRO partners’ Clinical Trial Management Systems and the documents contained in our partner’s eTMFs will be handled.
• Champion process improvement initiatives, in organizational process improvement efforts, identifying potential opportunities to leverage CTMS or its data to improve efficiency and/or compliance.
• Work closely with Clinical Operations and Clinical Records to develop streamlined data entry workflows, and partner with Clinical Operations and Quality Assurance to control CTMS data and eTMF document quality.
• Keep current on industry trends, regulatory changes, and GCP requirements, offering strategic guidance on their impact on CTMS and eTMF systems.
• Serve as a mentor and advocate for best practices across the organization, fostering a culture of continuous improvement and business impact for CTMS and eTMF.
• Depending on business need, this position may have direct reports and would establish, lead and develop the team, including recruiting, training, and providing strategic direction.
• Ensure systems and their underlying processes are operating as expected, proactively identify and address risks that would prevent optimal functioning, and work with business partners to fix system and process issues when they arise according to service level agreements.
• Develop and maintain any associated SOPs or work instructions for CTMS and eTMF utilization.
• Develop CTMS and eTMF training, define training requirements for users and ensure role-based training is completed as required.
• Partner with IT, Quality Assurance, Clinical Records, and vendors to ensure CMTS and eTMF are validated and remain in a validated state, including leading release management and change-control activities, and conducting periodic reviews.
• Oversee system user access and ensure system vendor administrates system access per agreed upon service level agreements.
• Partner with Clinical Operations and system vendor to build impactful and consistently reproducible reports that meet business needs and management expectations.
• Provide expert support for CTMS and eTMF audits and inspection, from a business system owner perspective.

Requirements

• Extensive experience in a pharmaceutical or CRO environment, with a proven track record as a business owner for clinical systems.
• Expertise in computer systems validation and a deep understanding of industry regulations, including ICH GCP guidelines and health authority regulations for clinical studies.
• Strong understanding of clinical operations workflows and study management reporting needs.
• Proficiency in CTMS and eTMF systems, particularly those from leading vendors (e.g., Veeva, Medidata).
• Bachelor’s degree (or equivalent).
• 12+ years of pharmaceutical or biotechnology experience.

Benefits

• The pay range that the Company reasonably expects to pay for this headquarters-based position is $232,800 - $273,800; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.