Position title: Operation Specialist
Location: Lawrenceville, NJ
Length of contract: 12 Months
Years of experience (minimum/maximum): 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.
Required education: Bachelor's degree required with an advanced degree preferred.
- Experience in clinical trial, data, or technology management
- Knowledge of GCP/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.
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 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.
- 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
By partnering with Kelly® Technology, you'll have direct connections to top companies around the globe—giving you the chance to put your tech skills to work on some of today's most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. We're here to help you gain experience, keep learning, and move your career forward.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
Apply on company website