Director/Sr. Director, Clinical Data Management

The Director/Sr. Director of Clinical Data Management at Seaport Therapeutics is responsible for leading the execution of data management strategies for all programs and studies. This includes overseeing clinical data management activities, developing SOPs, and ensuring compliance with relevant regulations. They collaborate with cross-functional teams to enhance data quality and meet project timelines, while acting as a subject matter expert on data management topics.

To qualify for the Director/Sr. Director position at Seaport Therapeutics, candidates should hold a Master’s or Doctorate with a minimum of 12 years in data management or a Bachelor’s degree with 14+ years of experience. They should have at least 8 years of managerial experience, a solid understanding of regulatory guidelines, experience with clinical databases, and ideally neuropsychiatric clinical trial experience.

The Director/Sr. Director of Clinical Data Management plays a crucial role in ensuring the integrity and quality of clinical data. Their leadership in data management directly influences the success of clinical trials at Seaport Therapeutics, ensuring accurate data collection, effective collaboration with CROs, and adherence to regulatory compliance, which are essential for advancing innovative neuropsychiatric medicines.

Seaport Therapeutics fosters a culture of learning and professional development, especially for the Director/Sr. Director of Clinical Data Management. They emphasize continuous improvement and encourage leadership to implement new technologies and processes that enhance data management efficiency, providing opportunities for growth both within the role and in the wider field of clinical research.

The Director/Sr. Director, Clinical Data Management position at Seaport Therapeutics is unique because it combines strategic oversight with direct impact on the quality of clinical studies. The role allows for leadership in a forward-thinking company at the forefront of developing novel neuropsychiatric treatments, providing an opportunity to influence both clinical data management processes and patient outcomes.

When answering this question, highlight specific projects where you were involved in the database build process. Discuss the systems you used, how you ensured clinical data integrity, and collaborated with other teams to meet project goals. Share tangible examples of improvements made due to your contributions.

Discuss your familiarity with these regulations and how you incorporate them into your data management framework. Provide examples of audit preparations you have conducted or compliance checks you have initiated to ensure adherence to national and international regulatory standards.

Emphasize your experience in building strong relationships with CRO partners, setting clear expectations, and establishing communication protocols. Talk about specific strategies you use to ensure that the CRO delivers quality data on time and how you tackle challenges when they arise.

When providing an answer, choose a situation that showcases your problem-solving skills and resilience. Detail the challenge, your approach to addressing it, and the positive outcome that resulted, demonstrating your capability in handling complex data management issues.

Discuss your methodology for prioritization, such as using project management tools or techniques like the Eisenhower Box. Share how effective delegation, time management, and clear communication with your team have helped you meet deadlines in high-pressure situations.

Talk about specific technologies you have utilized, such as EDC systems and data visualization tools like Tableau. Explain how these technologies enhance your data management processes and how you stay updated with advancements in this field.

Share your methods for implementing quality control measures, such as validation checks and periodic audits. Illustrate how you collaborate with various teams to ensure that data collection processes are standardized and errors are minimized.

Discuss your process for creating SOPs, including stakeholder involvement, drafting protocols, and how you ensure that the documents remain up to date with regulatory changes. Provide examples of successful implementations of SOPs and the positive impact they had on the clinical trials.

Emphasize your interpersonal skills and the strategies you use for conflict resolution. Share a specific instance where you successfully mediated a conflict, focusing on the methods you employed to promote collaboration and teamwork.

When answering this question, connect your professional aspirations with Seaport's mission. Highlight your excitement about contributing to neuropsychiatric drug development and how your experience aligns with the company's objectives and values.