Clinical Trial Business Capability Lead with (EDC) Electronic Data Capture

CLINICAL TRIAL BUSINESS CAPABILITY LEAD WITH (EDC) ELECTRONIC DATA CAPTURELAWRENCEVILLE, NJCandidate will need to be local and available to be on site once re-opened.Project Description: The Clinical Trial Business Capability Lead (BCL), Electronic Data Capture (EDC) Capabilities heritage the Client's role will provide overall leadership and governance of a GDO business capability end-to-end, encompassing process and technology strategy implementation. The BCL will be acting as the primary point of contact and advisor for the business capability stakeholders across GDO through proper stakeholder engagement and management. Success in that role will require ensuring proper demand management, prioritization and evaluating process impact assessments of key change initiatives ensuring value is delivered through the business capability. The role is also accountable for executing the business capability governance and process strategy including the use of technologies and related systems in support of clinical trial research programs. The role also ensures effective alignment of systems/technologies with other business processes and regulatory requirements for inspection readiness. Specifically, this BCL role will own the Electronic Data Capture capability for the Client's Rave EDC, including technology systems and processes, and is accountable for compliance with key regulatory and quality requirements pertaining to the capability. Aligned with our focus to collect data from patients in an effective and compliant manner, our focus on a comprehensive Electronic Data Capture capability governance aims at solidifying our Clinical Trial Data strategy, streamlining Clinical Data Management processes and enabling the Client's vision of being clinical trial sponsor of choice. This role is responsible for the overall leadership of the Client's EDC capability including operational governance of our RAVE EDC platform, enabling Data Management best practices, governing vendor relationships and supporting internal stakeholder's adoption.

• Serves as the Business Capability Lead/Subject Matter Expert for the business capability, including system/technology, regulatory inspection/internal audit.
• Leads development of a connected experience for Data Management stakeholders, investigators and site staff to support Clinical Data Capture best practices before, during and after trial completion.
• Effectively managing and engaging key stakeholders as per governance strategy to ensure business needs and requirements are met, prioritized and communicated.
• Serve as the SME of for the Client's RAVE EDC Study build, amendments, data extracts, reporting and new regulation impact assessments
• Serve as the SME for data interfaces between the Client's Rave EDC system and other internal/ external solutions
• Point of escalation for team that performs tactical work in the system such as timely access provisioning, de-provisioning and periodic access reviews
• Perform configuration changes and provide overall support for system
• Coordinate issue analysis, resolution and technology upgrades with vendor.
• Performs process impact assessments as needed to determine breadth and risks involved with proposed change initiatives
• Ensures proper documentation and oversight of all business processes, standard procedures and technical instructions related to business capability ensuring compliance with regulatory requirements
• Implement operational support model and training delivery plan to support the evolving needs from a business process and system life-cycle management perspective.
• Partners with IT drive a clear roadmap for the business capability that includes proper demand management, release planning and release management of technology system(s)
• Partners with R&D functions, internal and external partners including Contract Research Organizations (CROs)/vendors on strategy, development, implementation, and oversight of enhancement to current business capability
• Works broadly across Global Clinical Operations, Global Clinical Development, Global Data Management, Centralized Monitoring, Regional Clinical Operations, Clinical Trial Strategy, Quality & Compliance, and IT to leverage digital expertise and capabilities across the enterprise.
• Accountable for system/technology performance, project budget, stakeholder communications/change management, resolution/mitigation of issues and risks.
• Oversees system/technology work streams and outcomes.
• Contributes to internal/external continuous improvement initiatives.
• Monitors and oversees business capability operational health and metrics, including review of open tickets/requests and timely resolution
• Embraces a culture of quality, compliance and data integrity to promote a state of inspection readiness for the business capability
• Participate in audits and inspections for the business capability to ensure data requests by auditors and agencies are met

• Bachelor's degree required with an advanced degree preferred.
• Minimum of 8 years of direct experience independently leading and managing clinical trial (study, data, or system/technology) activities plus 1-2 years in a leadership position directing system, process, program or quality activities.
• Significant, demonstrated breadth of experience, versatility, and independent leadership and stakeholder management skills.
• Experience in clinical trial, data, or technology management
• Knowledge of Google Cloud Platform/ICH guidelines, regulations
• Experience with Electronic Data Capture (EDC) best practices and principles including Medidata RAVE EDC, including several modules in those platforms to support data capture, safety reporting, central monitoring, and clinical data reporting.
• Experience with Regulatory and Compliance requirements with regards to the Clinical Data Management
• Understanding of challenges and opportunities in managing data within clinical trials
• Understanding of Clinical Data Management and Clinical Development stakeholder needs, challenges and opportunities in clinical trials
• Experience working with global teams in different geographies with a diverse set of perspectives in different regulatory contexts
• Ability to analyze and interpret complex issues and propose innovative solutions
• Effective oral and written communication skills to influence, inform, or guide others
• Ability to effectively respond to regulatory trends, internal audits, inspection activities including root cause analysis/Corrective Action/Preventive Action (CAPA) plans for any findings.
• Experience working in a matrixed environment.