Job Details

  • Title: Clinical Trial Business Capability Lead
  • Code: RCI-BMS-27153-1
  • Location: Pennington New Jersey (NJ) 08534
  • Posted Date: 05/16/2019
  • Duration: 6 Months
  • Status: Open
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  Job Description

  • The Business Lead role will provide overall leadership of system/technology projects (End-to-End process) acting as the primary point of contact and advisor for the business users of the system.
  • Accountable for business process strategy and use of data technologies and related systems in support of clinical trial research programs.
  • Ensures effective alignment of systems/technologies with other business processes and regulatory requirements for inspection readiness.

Responsibilities & Major Duties:

  • Serves as the Business Lead/Subject Matter Expert for the system/technology including point of contact for regulatory inspection/internal audit.
  • Drives development, execution, and monitoring of the system/technology Business Plan in collaboration with key stakeholders.
  • Partners with R&D functions, internal and external partners including Contract Research Organizations (CROs)/vendors on strategy, development, implementation, and oversight of new and existing platform capabilities.
  • 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 new technologies and external trends to ensure company is leveraging the best of what is available

Requirements:

  • 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 Electronic Data Capture practices and principles
  • Experience with Medidata RAVE and Oracle Clinical technologies
  • Ability to analyze and interpret complex issues and propose innovative solutions
  • 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.
  • Experience working in a matrix environment.