- 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
Talk to our Recruiter
- Name:Vishal Trivedi
- Email: email@example.com
- Phone: 908-704-8843 ✖ 435
- 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
- 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.