The Executive Director of Data Management will be responsible for leading and managing the strategic and operational aspects of data management in the support of Clinical Development functional activities, including database build, database lifecycle management, data review, vendor management and oversight across all studies and programs. The Executive Director will manage the company program-wide database infrastructure, ensuring efficiency and consistency where possible, review trends and implement strategy for data collection improvements. They will also implement data privacy compliance measures as required for each clinical trial.

This position will ensure that all data collection is per protocol(s), in accordance with all necessary regulations and aligned across Clinical, Clinical Development and Biometrics needs in support of ad hoc, protocol and regulatory deliverables. The Executive Director will work closely with key stakeholders including Clinical, Clinical Operations, and Biometrics, as well as other

Major Duties/Responsibilities

• Establish and provide leadership of the Data Management team by providing expertise and guidance to the clinical development team regarding data standards, data quality, validation, integration with regulatory requirements
• Develop Data Management Departmental SOPs and ensure staff adherence to company policies, SOPs, and regulatory requirements
• Oversee all aspects of the Data Management and Clinical Programming teams including resource planning, deliverables, hiring, staff training, staff appraisals, performance reviews, and annual salary reviews
• Oversee and/or provide clinical study level data management oversight of outsourced clinical trials including project management, vendor management, coordination of internal reviews, and oversight/approval of deliverables.
• Author/review eCRFs, CCGs, and Data Management Plans. Assist as needed with clinical documents such as clinical protocols, Investigator Brochure updates, and regulatory reporting updates
• Lead database design and production, ensuring that CROs, vendors and internal staff meet the required quality standards
• Review data analysis listings and report on performance and quality with expertise in metrics/KPI analysis; review clinical data within studies and across programs for trend analysis
• Act as liaison with CROs and third-party data vendors, as needed, for data management organization.
• Collaborate with the internal functional leads to ensure all stakeholders’ needs are addressed and communicate project status and issues.
• Responsible for instructing the implementation of new or advanced systems, processes and resources to increase productivity
• Responsible for department resourcing and budget/budget forecasting
• Guide data management activities for regulatory submissions
• Other projects and responsibilities as needed

 

Education & Professional Experience

Required:

• Minimum of a B.S. in related field with 15+ years of Data Management within the biotechnology/pharmaceutical industry with detailed knowledge of data management platform and software, clinical trial databases, CDISC standards and pharmaceutical drug development process.
• 10+ years of proven management experience
• Knowledge of FDA requirements, including ICH GCP guidelines, and other applicable regulations and practices, including data privacy regulations and implementation as related to data systems and data collection.
• Experience in regulatory inspections is a plus
• Knowledge of submission requirements, (e.g. NDA, BLA, and MAA)
• Experience managing and mentoring personnel.

 

Skills

• Ability to prioritize and manage through complex processes/projects.
• Proven strong data management skills with focus on executing deliverables and on timelines.
• Excellent communication, organizational, negotiation and interpersonal skills required.
• Effective in promoting and maintaining productive internal and external relationships. Proven leadership and team building skills, along with success in proactive risk mitigation and problem solving.
• Flexible and creative to meet the needs of a growing, dynamic company.
• Successfully able to manage clinical data management vendors, contractors and service providers
• Good analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development

Posted On: Tuesday, January 7, 2025