- Expiry Date: 16 December 2021
The Clinical Trial Business Capability Change Manager role will provide tactical support, oversight and leadership on change initiatives within the Clinical Trial Business Capabilities system/technology projects. The role is accountable for ensuring change for clinical trial systems is adequately managed in an operational state within the area of capabilities while maintaining effective alignment of systems/technologies with other business processes. The role is also accountable for effecting change in a controlled manner, in compliance with regulatory requirements while maintaining the clinical trial business capability in an inspection readiness state. The Business Capability Change Manager will work closely with the Business Capability Lead to plan Change Management activities specific to a Clinical Trial Business Capability, including training, testing, documentation and process mapping. This is an essential role to the success of the Clinical Trial Business Capabilities organization to support an effective change process leading into a stable operational state across several business capabilities.
Serves as Key Subject Matter Expert for change management activities within the clinical trial business capabilities and associated system/technology, including Stakeholder mapping, Stakeholder engagement, Training, Business Process Impact Analysis, and Adoption Strategy/Metrics.
Support in the development, execution, and monitoring of the system/technology Change Management Plan in collaboration with key stakeholders.
Lead Stakeholder Engagement meetings to ensure awareness is maintained across stakeholder groups around Business Capabilities
Partners with R&D functions, internal and external on implementation, and oversight of new and existing platform capabilities.
Responsible for the development of system and reporting requirements for the Clinical Trial Business Capability in partnership with IT colleagues
Support activities for system/technology performance, project budget, stakeholder communications/change management.
Lead training and communication for stakeholders impacted by change initiatives to the application or system processes for specific capabilities. Liaise with user forums or working groups
Partners with the R&D Learning on development of training materials
Delivers training to trainers and super-users (train-the-trainer)
Supports user acceptance testing of system enhancements and upgrades, providing SME advice on testing approach, script writing, review and approval.
Lead testing and support validation efforts for business capabilities, including participating in Operational Qualification and Performance Qualification of systems.
Defining a suitable test strategy and writing test cases to support release management of systems/technologies within a specific clinical trial business capability.
Participate in system/technology work streams and outcomes in change initiatives.
Contributes to internal/external continuous improvement initiatives.
Bachelor’s degree required. Master’s degree preferred.
Minimum of 3-5 years of direct experience independently leading and managing clinical trial (study, data, or system/technology) change management activities plus 1-2 years in a project management position directing system, process, program or quality activities.
Bachelor’s degree required with an advanced degree preferred. Minimum of 3-5 years of direct experience independently leading and managing clinical trial (study, data, or system/technology) change management activities plus 1-2 years in a project management position directing system, process, program or quality activities. Significant, demonstrated breadth of experience, versatility, and independent leadership and stakeholder management skills. A minimum 3+ years experience working on system enhancements, incl. requirements, user acceptance testing, rollout of new functionality, documentation of system related business processes.
Experience in clinical trial, data, or technology management
Knowledge of Clinical Trial Business Capabilities such as:
Clinical Trial Execution Capabilities such as eTMF, eConsent, Clinical Trial Portals, Shared, Patient Portals, HCP Portals, Shared Investigator Platform (SIP), Patient Recruitment / Engagement.
Clinical Trial Data Capabilities such as data warehouses/workbenches (CDW), metadata repositories (MDR), Electronic Data Capture (EDC) Electronic Clinical Outcome Assessments (eCOA) and Reporting.
Knowledge of GCP/ICH guidelines, regulations
Experience with Change Management principles and best practices for technology systems
Experience in computer system validation with GCP requirements
Ability to analyze and interpret complex issues and propose innovative solutions
Experience with 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.
Experience working in a matrix environment.
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