Associate Director, EDC Delivery Services and Management in Basking Ridge at Daiichi Sankyo

The Associate Director, EDC Delivery Services and Management is a member of the Biostatistics and Data Management team and serves both as a subject matter expert and leader of a group responsible for the oversight, delivery, and management of Electronic Data Capture system services including the areas of study database build, system administration, core configuration, post-production changes, and reporting. The individual will plan, coordinate, and deliver high quality study database builds across all clinical studies, lead operational process and technology improvements, and ensure effective quality oversight of external partners including CROs, Functional Service Providers, and Technology providers performing activities on behalf of Daiichi Sankyo to ensure high quality and timely delivery of clinical databases. The individual will also provide guidance and expertise on industry best practices applied to data management, study teams, and other stakeholders in the use of technology, data standards, processes and improve quality to deliver enhanced business capabilities and efficiencies. This position will  work closely with other members of the Biostatistics and Data Management teams, DS Information Technology, External CRO Partners, Functional Service Providers, Technology Providers, and other Stakeholders.

Responsibilities

Leadership, Direction, and Strategy:

• Lead the development and implementation of EDC capabilities, solutions, operational improvements, and services strategy for the department.
• Manage direct reports including the development, coaching, and mentoring of team members.
• Establish and manage accountability for the EDC Delivery Services and Management group. This includes ensuring oversight, guidance, timely delivery of clinical study databases for all studies with high quality, user access management, leading initiatives with cross-functional impact, and operational support.
• Contribute to the overall clinical systems strategies, roadmap, plans, and infrastructure development.
• Engage with the BDM Infrastructure committees to assess and/or implement any changes required for improved efficiencies, compliance, and operations.
• Foster strong and productive working relationships with key internal and external stakeholders, advance business objectives, and drive results.

Project Management:

• Manage tactical and operational tasks and deliverables to achieve and deliver high quality clinical databases for all studies.
• Manage the study database build project plan, database development trackers, and gather metrics to ensure timely delivery of the study database build activities.
• Manage all quality study build deliverables, post-production changes, and maintain inspection readiness of the procedural documents, associated forms, and trackers in accordance with the GSOP/GSOIs in partnership with project and study data managers, CRO partners, and functional service providers.
• Proactively identify and resolve issues that may influence and/or impact study build quality, post-production changes, and other deliverables.
• Provide effective quality oversight of the study database build for outsourced studies to ensure high quality and timely delivery of the clinical study databases.

Functional Expertise:

• Serve as a subject matter expert and provide oversight, guidance, and technical support in the planning, coordination, and delivery of high quality clinical study databases for all studies.
• Partner with the Project and Study Data Managers and provide guidance, and operational study support of EDC services to the study teams, as needed.
• Lead EDC operational improvement initiatives anchored around process, technology, and quality to address potential gaps, improve efficiencies and productivity, and execute to completion in a timely manner.
• Establish appropriate SOP/SOIs, work procedures/guidance, database development templates, logs, quality procedures, risk & impact assessment & mitigation procedures, to maintain audit readiness, data integrity, security, consistency and transparency across studies.
• Establish a robust, scalable, and reliable reporting infrastructure strategy that enables the generation of on-demand and scheduled operational reports for downstream consumption.
• Improve the oversight and coordination of periodic review of EDC user access management for external users in partnership with CRO Partners and Functional Service Providers for improved quality, security, integrity, and compliance for all studies.
• Lead content preparations and follow-up actions related to internal audits, and health authority inspections.
• Engage, initiate, and drive to resolution any issues pertaining to the functioning of the EDC system, process, and quality that impact the study and the timelines in collaboration with the technology providers and CRO partners, as necessary.
• Lead and coordinate the implementation of system patches, upgrades, and maintenance activities with internal and external stakeholders.
• Engage in the assessment, evaluation, and implementation of enhanced functional capabilities of current system technologies and/or new clinical system technologies of interest for R&D.
• Develop, coach, and mentor team members; support and implement individual development plans; and seek out training and growth opportunities.

Operational Efficiency / Continuous Improvement:

• Identify opportunities for continuous process, technology, and quality improvements.
• Proactively identify risks and mitigation approaches to overcome project impediments and improve operational efficiencies.
• Establish metrics to help determine the efficiency, quality, and consistency across areas of study database build, post-production changes, and user access management among others.  

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education

• Bachelor's Degree or higher in life sciences or related field required

Work Experience

• Minimum of 7 years of Global Clinical Trial Experience in the device/pharmaceutical/CRO industry with expertise in EDC systems and services. Skilled in areas of core configuration, study database build, post-production changes, and reporting. Knowledge of other clinical system technologies; knowledge of CDASH and CDISC data standards; knowledge of data collection  and integration tools and technologies.  Required

Competencies

• Strong knowledge of industry leading EDC technology platforms (e.g., Medidata Rave, Veeva CDMS, Oracle/Inform, Merative (Zelta), etc.)
• Knowledge and awareness of industry trends, best practices, and emerging technologies for data collection, management, and reporting.
• Strong expertise in areas of data management processes including study database build, database lock, post-production changes, clinical data standards, technology, and quality.
• Strong working knowledge of drug development, GxP/ICH guidelines, computer systems validation, regulatory compliance, and 21 CFR-Part 11.
• Strong knowledge and experience in maintaining systems, processes, and quality deliverables for inspection readiness, and CAPA response and management.
• Ability to proactively resolve complex issues, decision making, and driving initiatives to completion in a timely manner.
• Influential leadership and communication capabilities with a proven ability to engage and develop colleagues.
• Strong stakeholder management and project management skills.
• Excellent oral and written communication skills