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The position will report into the AD, Clinical Trial Business Capabilities, Strategy & Operations Lead and take project direction from Business Capability Leads and Directors within Clinical Trial Business Capabilities (CTBC). This role will be required to work with multiple stakeholder groups.
The current need for CTBC includes management and support of clinical trial management system integrations, including access provisioning using SailPoint and safety distribution using ePharma solutions (CelAlert). Project needs for the role may evolve according the organizational needs and the experience/skill level of the Consultant.Description of Services:• Serve as central point of contact for cross-functional business stakeholders and IT for establishment of new processes, management and communication• Serve as central point of contact for compliance reporting needs• Project manage and support User Access Management (UAM) systems and enhancements, and support established solution for safety distribution using ePharma solutions• Serve as Business Administrator for Clinical Trial Management System (CTMS), including ongoing management and support for user access, profile management, and appropriate routing, escalation, and resolution of issues• Manage communication across business stakeholders. Drive decision making and gain alignment when required• Creation of process documentation, training and reference materials for business capabilities• Prepares systems status report and documentation to keep stakeholders informed of systems status and potential risks so they can take appropriate action• Support continuous improvement initiatives as needed• Awareness of Change Management principlesPosition Requirements:• Minimum of 4-7 years of experience and 3+ years in Pharmaceutical Clinical Development, including clinical operations and data management systems and processes, required• Technical expertise in clinical trial management systems and integrated capabilities• Strong command of process management and end-to-end lifecycle management. techniques and tools (e.g., process planning, stakeholder communication, presentation development, action/decision tracking, organizational skills)• Understands the value of process-centric approach to business analysis and capability development.• Strong experience in analyzing business problems, defining processes using flow charts, and implementing technical solutions• Experience creating training materials for process and technical solutions• Strong ability to organize and present ideas in a convincing and compelling manner• Ability to persuade and influence others with effective verbal and written communication• Ability to establish relationships with key leaders across functional areas• Knowledge of Google Cloud Platform/ICH guidelines• Bachelor’s degree required; advanced degree preferred- ID: #44558479
- State: New Jersey Lawrenceville 08648 Lawrenceville USA
- City: Lawrenceville
- Salary: Depends on Experience
- Job type: Contract
- Showed: 2022-08-03
- Deadline: 2022-09-26
- Category: Science/biotech