Job Summary

Summary

• The Associate Director, Clinical Database Applications and Reporting is a member of the Biostatistics and Data Management team and serves as a subject matter expert responsible for setting the overall programming strategy including the oversight, guidance, implementation, and management of clinical database applications and reporting.
• The responsibilities include advancing operational excellence by standardizing reporting, scaling programming strategies, automating workflows, and delivering high-quality outputs that meet user requirements by collaborating with variety of internal and external stakeholders including leading all aspects of end-to-end programming efforts.
• In addition managing quality of data validation programming deliverables; maintaining compliance and inspection readiness of clinical applications, reports, and supporting process documentation; and reporting process are some of the key requirements of the role 
• This position provides expertise within Data Management by partnering with internal and external stakeholders (e.g. DM Portfolio Delivery, Data Acquisition & Processing, Precision Medicine, CROs, External Vendors, etc.) to optimize data programming services on behalf of Daiichi Sankyo.
• In addition, excellent verbal/written skills, analytical, organizational, and interpersonal skills for working effectively with people at different levels are some of the requirements of this role.  This position requires skills in working in a fast-paced environment, continuous improvement, project management, change and risk management.

Job Description

Responsibilities

Leadership, Direction, and Strategy:

• Establish programming strategy in designing, developing, and maintaining reporting business needs, including programming capabilities assessment, technology and infrastructure requirements of new and/or existing clinical database applications and reporting solutions.
• Act as a subject matter expert in advanced clinical data programming, data transformation, visualization, and emerging technologies to elevate and modernize internal reporting capabilities.
• Provide operational leadership and management of clinical database applications and reporting solutions to address business needs consistent with regulatory requirements including GxP, 21 CFR Part-11, data protection and privacy requirements.
• Ensure programming related technical and end user support to other areas of Data Acquisition & Processing, for the development of reports, data listings, and data visualizations consistent with study requirements and integrated data review plans.
• Manage direct reports including the development, coaching, and mentoring of team members.

Project Management:

• Drive successful delivery of clinical data management programming objectives by aligning priorities, streamlining workflows, and optimizing resources in collaboration with cross-functional stakeholders.
• Ensure effective quality oversight of the core clinical database applications and reporting, supporting processes, technology, and infrastructure improvements; maintain audit and inspection readiness of all the deliverables.
• Oversee the quality of data listings, reports, patient profiles, and metrics, ensuring high-quality, timely outputs that support operational insights in line with integrated data review plans.
• Manage and maintain standard library of data listings and reporting objects to maximize reuse, efficiency, productivity, and standardization.
• Manage data exchange agreements and deliver quality data extracts for internal and external stakeholder consumption compliant with regulatory, data protection, and data privacy requirements.

Responsibilities Continued

Functional Expertise:

• Serve as a subject matter expert for the oversight, guidance, implementation, and management of clinical applications and reporting solutions with expertise in Data Management Systems.
• Support the integration of clinical data from CRF and non-CRF data sources to streamline workflow, improve efficiencies, and quality of data management processes and deliverables.
• Serve as a trusted SME in clinical data management programming and reporting, leading resolution of complex issues and guiding internal teams and external partners to achieve successful outcomes.
• Partner with clinical database programming, external data acquisition & management, study data managers, and external vendors to perform quality checks for the reconciliation of external data with EDC.
• Contribute to the development of standard and custom reports and data listings specifications; develop and evaluate complex listings and reports including patient profiles, dose modification listings, exception listings, medical coding, among others to support critical and time-sensitive study milestones.
• Collaborate with the clinical database programming group to create, manage, and maintain validated toolsets, macros, and automated scripts for code optimization and standardization to maximize efficiencies, consistency, and quality of the outputs.
• Explore novel and automated approaches to data extractions, data wrangling, and contextualizing data assets to develop innovative solutions compliant to regulatory, data protection and privacy requirements.
• Establish appropriate SOP/SOIs, work procedures/guidance, job aids, and trackers to guide the operational use of custom reports, data listings, and data visualizations for study needs.

Operational Efficiency / Continuous Improvement:

• Identify and address areas of gaps, and opportunities to enhance and improve operational efficiencies and productivity through automation, code optimization and standardization, process improvements, and improving the quality of actionable insights.
• Proactively identify risks and mitigation approaches to overcome impediments and improve operational efficiencies.

Qualifications

Work Experience

• Minimum of 7 years of Global Clinical Trial experience in the device/pharmaceutical/CRO industry with expertise in clinical database programming, methods, and techniques supporting Clinical Data Management systems and services required.
• Skilled in areas of data validation programming, creating complex data listings, reports, and data visualizations; reconciliation of external data; expertise in industry standard reporting required
• Experience with data visualization tools such as Qlik, Spotfire, Tableau, Power BI, JReview, SAS, Domo, among others required
• Knowledge of CDASH and CDISC data standards; knowledge of data acquisition, aggregation, contextualization, integration tools, and technologies required

Competencies 

• Strong knowledge and techniques of data extraction, data wrangling, exploration, and contextualization of data assets in clinical domain.
• Expertise in data validation programming and analysis proficiency with SAS tools, SQL, and Python/R.
• Deep experience working with a variety of industry standard reporting and data visualization tools for data insights, data listings, and custom reports. 
• Proficient in industry standards, medical terminology, and clinical trial methodologies.
• Knowledge and awareness of industry trends, best practices, and emerging technologies for data collection, management, reporting and analytics.
• Knowledge of industry standard commercial clinical systems such as EDC, CTMS, IRT, CDR, and eTMF.