Director/Sr. Director, Clinical Data Management - Seaport Therapeutics

Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary Glyph^TM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders. For more information, please visit www.seaporttx.com.

Seaport Therapeutics is seeking someone to lead their clinical data management team. Reporting to VP, Head of Biometrics, the Director or Sr. Director of Clinical Data Management will lead and manage the function of Clinical Data Management. This role involves ensuring the integrity and quality of clinical data and collaborating with cross-functional teams to meet project timelines and regulatory requirements. This position offers a unique opportunity to make a significant impact on the quality of clinical studies by providing expertise in all aspects of clinical data management.

Primary Responsibilities

• Lead and provide oversight for the execution of data management for all programs and studies of the company and accountable for all data management and clinical programming activities
• Establish and lead Data Management function and develop Data Management SOPs and work instructions.
• Develop and implement data management strategies that align with clinical trial objectives, regulatory requirements, and industry best practices.
• Represent clinical data management as Subject Matter Expert (SME) for various operations, including, but not limited to, electronic data capture, external data standardization, collection, and processing, and the creation of standard data collection forms and associated validation checks and collection processes.
• Oversee the CRO during the planning and execution of data management activities for multiple clinical trials, ensuring timely and accurate data collection, validation, and reporting. This includes all data cleaning activities including processing queries, performing ongoing data review and reconciliations, identifying and tracking data issues and trends.
• Work closely with cross-functional groups to provide input into study protocols, SAPs, and other clinical documents, to ensure quality data collection and management.
• Review or contribute to data management deliverables including Data Management Plans, Data Validation Manuals, CRF Completion Guidelines, Data Transfer Specifications, Lab Specifications, etc.
• Identify and implement process improvements and new technologies to enhance data management efficiency and data quality.
• Contribute to data system compliance by ensuring compliance with all applicable regulations, following the established guidelines of national and international regulatory authorities and participating in audits and inspections as needed.

Qualifications

• Master’s or Doctorate and 12+ years of data management experience or Bachelor’s and 14+ years of data management experience
• 8 years of managerial experience in data management function and experience in leading group of data managers
• Experience in clinical trial database build, case report form design and familiar with CDISC and regulatory requirements
• In-depth understanding of Clinical and Data Management regulations and guidelines: ICH, GCDMP, 21CFR Part 11, GDPR and functional knowledge of CDISC/SDTM/ standards.
• Experience managing Data Management CROs and vendor.
• Deep Experience in reviewing clinical data.
• Hands-on deep experience working with EDC systems (e.g. Rave, Veeva).
• Neuropsychiatric Clinical Trial experience is preferred.
• Experience with Data Visualization Tools (e.g. Spotfire, Tableau, RShiny, Dash).
• Experience with a programming language is a plus.
• Excellent oral and written communication skills, project and personnel management skills and organizational skills
• Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
• Strong motivation in learning and professional development aligning with job responsibilities