Sr. Operations Manager
Job TitleSr. Operations Manager
In this role, you have the opportunity to
Oversee the activities of the Motion Biosensors Clinical Trials Operations Team. This team is charged with the timely and effective delivery of rental products and supporting services to external customers utilizing Motion Biosensor products and services in large scale pharmaceutical clinical trials. This role also includes oversight of the Motion Biosensor Service Center. Those in this role must have a wide range of experience and expertise enabling resolution of complex issues in creative and effective ways within the framework of a regulated medical device quality and business system. This is a growing business, so this role must be capable of engaging in continuous improvement of existing processes and procedures as well as implementing new processes, methods and techniques to support increasing customer demand for motion biosensor products and services as well as new offerings for our Clinical Trials customers.
You are responsible for
- Owner of all aspects of Clinical Trials Operations with overall responsibility to support on-time trial launches, and smooth trial execution through accurate delivery of products, training and data services to pharmaceutical clinical trial sponsors.
- Ensures high quality service and operational performance in all aspects of Clinical Trial Operations and reports status to the business segment director
- Responsible for Clinical Trial Operations employee staffing, supervision, development and evaluation.
- Projects demand to plan rental inventory and staffing levels in advance.
- Develops operational objectives, and work plans for the team to ensure efficient and effective day to day operations as well as integration of new clinical trial product and service offerings into operations.
- Leverage Sleep & Respiratory Care business and quality systems (ie SAP, QMS) to establish and maintain scalable operations that enable delivery of efficient product support, service and clinical trial services.
- Collaboration with Product Management to include operational consideration during new offering or solution design process.
- Ensures product and program training for Clinical Trials Operations staff, including product and business system knowledge and support of overall service requirements. Training is updated as new products and services are released.
- Makes decisions on administrative or operational matters to ensure effective achievement of departmental objectives.
- Analyzes operational processes, establishes escalation procedures and oversees training needs assessment to identify opportunities for service delivery improvements.
- Effective communication of operational status and capabilities to management and other departments in the organization.
- Financial forecasting of revenues to be generated via the services delivered by Clinical Trials Operations
- Provides input for annual departmental expense budgeting and quarterly spending adjustments
- Collaboration with Quality to facilitate and complete customer requests for documentation and on-site audits
To succeed in this role, you should have the following skills and experience
- Bachelor's degree in relevant field
- 3+ years in medical device quality, operations, service or related field
- Managerial experience
- Project Management experience
- Technical proficiency with computer applications such as Microsoft Excel, PowerPoint
- Operational, or service related business system experience. SAP Preferred
- Experience operating and documenting procedures under medical device Quality Management Systems preferred
- Familiarity with service center operations
- Experience as a contributing participant in vendor or quality system audits
- Familiarity with data privacy and security requirements for medical devices and pharmaceutical clinical trials
- Exposure to change management and principles of lean process development
- Proven communication skills and influencing ability
- Significant attention to detail
- Previous exposure to pharmaceutical clinical trials preferred
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