Business Capability Lead
Key Responsibilities and Major Duties
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 digital experience for external investigators through the ISR process.
Owns the governance strategy, roadmap, execution, and monitoring of the business capability.
Effectively managing and engaging key stakeholders as per governance strategy to ensure business needs and requirements are met, prioritized and communicated.
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.
Develop and 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 to set and 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 vendors on strategy, development, implementation, and oversight of enhancement to current business capability
Works broadly across Global Development Operations, Regional Clinical Operations teams, Protocol Management teams, Field Medical teams, Commercial, IT, Public Affairs and Legal to leverage digital expertise and capabilities across the enterprise.
Accountable for system/technology performance, platform, integrations, 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.
- 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 GCP/ICH guidelines, regulations
- Experience with Investigator Sponsored Research (ISR), Expanded Access, Compassionate Use and Named Patient Program (NPP) practices and principles
- Experience with Regulatory requirements with regards to Investigator Sponsored Research and associated capabilities
- Understanding of ISR, Expanded Access, Compassionate Use and NPP needs, challenges and opportunities in clinical research
- Experience working with global teams in different geographies with a diverse set of perspectives in different regulatory contexts
- Knowledge of Veeva Vault and Salesforce.com capabilities
- Ability to analyze and interpret complex issues and propose innovative solutions
- Experience with leading teams and driving innovation
- Strong project management and planning skills
- 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.