Senior Operations Specialist
Job Summary and Purpose:
The Senior Operations Specialist leverages expertise and knowledge to plan and manage initiatives and activities designed to improve the quality, efficiency and effectiveness of the delivery of studies to Sponsors. The Sr Operations Specialist develops and implements processes, change management plans, standards or operational plans with the goal of operational excellence across the business collaborating across a group of diverse stakeholders.
They will support a wide range of activities within the Business & Operational Excellence group. Specific tasks depend on the functional area, including Process improvement, support of training content and/or development and deployment of change management initiatives. This role executes functional priorities with minimal oversight.
Main Duties & Responsibilities
- Support the vision of and commitment to continuous improvement in operational excellence across all activities.
- Lead the evaluation of business processes and workflows to identify opportunities for improvement or automation under direction of a supervisor.
- Participate with stakeholders in root-cause problem-solving techniques to identify core process challenges.
- Support the development of recommendations for process improvement, leveraging subject matter experts for critical input.
- Partner with cross functional leadership to prioritize improvement opportunities and support strategic initiatives.
- Partner on the design and implementation of new business processes with organizational context and priorities in mind.
- Lead change management initiatives and support business through a communication framework assessment of impact on roles and deploy a variety of tactics to support change management effort to ensure adoption and sustainability of process changes.
- Lead internal communication to effectively update stakeholders on progress, performance, key issues, and blockers that may impact business attainment or critical program and project completion
- Identify operational risks and lead implementation of mitigation plans.
- Ensure or lead the documentation of business process.
- Work with leadership to establish key performance metrics and dashboards for monitoring operational performance.
- Provide insight into training and guidance to teams on new processes and how to identify improvement opportunities, building awareness on continual improvement initiatives
- Support standardized best practices and processes across the organization to ensure consistency and sustainability.
- Monitor, measure, and analyze the effectiveness of new initiatives and processes, making adjustments as needed.
- Monitor adoption of process, system and organizational changes to ensure long term and sustained adoption.
- Prepare and maintain tools and templates to support execution
- Schedule meetings, take notes, and track actions
- Travel as needed
Education and Experience:
Minimum:
- Bachelor's degree or equivalent experience
- 5-7 years in change management, operations support, and process improvement experience
- Experience in CRO/pharmaceutical/biotechnology drug development or demonstrated competency in the key areas of the role
- Strong drug development experience with understanding of other functions relevant to the position.
Knowledge, Skills, and Competencies:
- Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint, Teams)
- Strong written and verbal English communication skills
- Knowledge of ICH-GCP and regulatory guidance
- Strong interpersonal and training skills
- Self-motivated and detail-oriented
- Ability to work independently and in teams
- Strong professionalism, sense of ownership and pride in quality of outputs
- Understanding of change management models (ie ADKAR) and use of change radars
- Flexible attitude with respect to work assignments and ability to thrive in a fast-paced dynamic environment
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