Associate Director, Clinical Data Management

Overview of Role:

We are looking for an experienced Associate Director, Clinical Data Management that will contribute to and support the company's research and development efforts to create high value therapeutics to address unmet medical needs. The Associate Director, Clinical Data Management independently leads the data management components of a clinical trial ranging from small early phase to large global and late phase programs. This role will direct the planning, implementation and overall direction of executing/achieving clinical trial data management activities including CRF/eCRF design, database development, validation programming, data review, discrepancy management, and database lock. Additionally, the position will manage data management staff, Contract Research Organizations (CROs) and service providers' activities in overseeing the data management process life cycle in coordination with internal Biostatistics, Clinical, and Regulatory teams to ensure the accurate, efficient, and complete data collection for clinical trials.

Role and Responsibilities:

• Provide expertise and contribute to the strategy and development of the Clinical Data Management Portfolios to ensure data quality in support of clinical study data milestones and deliverables
• Lead and support establishment of systems and processes to help ensure clinical data security, integrity, and long-term goals of the business function, in alignment with company priorities
• Leads the data management of overall drug development process with early and late phase clinical trials in large or complex development program(s)
• Provides technical expertise to develop and implement clinical data standards, data management plans, data transfer agreements, and data flow processes to ensure timely and quality data delivery for analysis purpose
• Oversees the process to identify, evaluate and select CROs, vendors and technology for CDM activities
• Leads, designs and/or oversees eCRF design, eCRF specifications, eCRF completion guidelines, annotated CRFs, User Acceptance Testing, query logic, edit checks, data query resolution, SAE reconciliation between clinical and pharmacovigilance databases, vendor data reconciliation & cleaning, data migration and database closeout for clinical trials
• Represents Data Management and promotes productive collaboration with other functions (e.g., Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Translational Science, Project Management, Regulatory, QA, and IT) to ensure proper alignment around data management activities & deliverables, operational excellence, compliance with regulations, policies, procedures, and clinical objectives
• Supports cross functional teams and studies to handle data management questions, troubleshoot, help resolve issues and mitigate risks. Initiates continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams and studies
• Works with the Director of Clinical Data Science (CDS) to enhance efficiency, optimize costs, and drive excellence
• Works with the Director of Clinical Data Science to establish CDM processes and procedures including SOPs to ensure highest data quality/integrity/security and regulatory. compliance with FDA regulations, GCP, ICH guidelines and Good Clinical DM Practices.
• Leads clinical data management activities during regulatory audits, ensuring compliance with industry standards and regulations, and providing expert input throughout the audit process
• Works with the Head of Statistical Programming & CDS to manage departmental budget and execute resource planning across multiple projects

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  Company

  Summit Therapeutics Sub, Inc.

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