Primary ResponsibilitiesServes as Director supporting company operations and initiatives, maintaining quality service and supervising technical aspects within the therapeutic area by:
- Working with Business Development to win new business and expanding Clario's market share
- Advising and communicating with clients for the successful use of imaging in each trial
- Providing medical and scientific support to Clario study teams and departments for the delivery of services in ongoing projects
- Identifying new tools and services to improve and expand Clario's offerings
- Identifying process improvements to increase efficiency and accuracy of read applications, timelines to execution; this requires a deep understanding of the business and operational processes
- Developing strategies to strengthen knowledge share and interactions amongst Medical and Scientific Affairs, Product Development, Validation Services and Data Management as it relates to requirements
- Aligning system enhancement decisions and opportunities for growth with organizational strategic objectives
- Cultivating a team to better understand the logic, criteria and have a customer centric mentality
- Providing SME support for software UAT, training of internal end users and client demonstrations
- Providing technical input and support to the Therapeutic Area Operations.
- Assisting with study technical documentation including imaging charters, manuals, study specific rules, end of study reports, etc.
- Maintaining relationships and providing scientific support and consultation to Clario's clients.
- Assisting in new study proposals including RFP review and proposal generation, teleconferences with customers and sales presentations.
- Ensuring quality and scientific integrity of all project deliverables.
- Jointly accounting for on-time delivery of final project results and final reports to customers.
- Working towards customer satisfaction.
- Providing input on the trial design, review methodology and quality control of image data
- Providing input to the product development team to support defining enhancements and new features
- Gathering and documenting requirements from scientific teams, project teams and other stake holders for client configuration
Supports VP, Medical and Scientific Affairs by:
- Assessing and upgrading the service level of medical affairs with suggestions on new and/or innovative imaging tools, processes, procedures, interpretation techniques, etc.
- Assisting with research and the development of applicable white papers, manuscripts, presentations, etc.
- Leading the interpretation and development of operational strategies for new imaging criteria
- Reviewing and engaging with clients by providing input for protocol, charters and data queries
- Monitoring delivery metrics and trends to provide continual ongoing improvement to the department
- Assisting with identification, specification and implementation of new service offerings.
Provides team leadership by
- Leading by example with professional and collaborative conduct
- Developing and delivering training to multiple departments
- Establishing team performance expectations and guidelines
- Collaborating with departmental managers for team coaching/mentoring
- Establishing a work environment conducive to team member growth and development
Support clients and ensure delivery of services for individual studies by:
- Maintaining key client relationships through participation in governance meetings
- Providing input on the trial design, image acquisition and quality control and review methodology by reviewing and editing clinical trial protocols, imaging manuals, imaging charters, read rules, study reports, data transfer specifications and data queries
- Participating in Investigator Meetings and Scientific Conferences as Clario's representative
- Training the study team on the medical and scientific details of the project
- Assisting Clinical Project Management in communication with clients, especially for critical deliverables or escalations
- Gathering and documenting study requirements (e.g., read criteria) from scientific teams, project teams and other stake holders
- Contributing to Business Requirements documents by ensuring accurate translation of charter content to technical requirements
- Identifying and training readers for each study
- Monitoring reader performance by participating in Read Monitoring activities
- Addressing technical issues and questions that arise during the conduct of the study
Ensures departmental productivity and identifies opportunities for greater departmental efficiencies and quality by:
- Standardizing processes and best practices within therapeutic area
- Monitoring delivery metrics and trends (including reader agreement) to provide continual ongoing improvement to the department
- Working with Senior Management and Directors when prioritization of deliverables is required
- Identifying new tools and process improvements to increase efficiency and accuracy of reading, development of read applications, timelines to execution
- Assessing business need for technology enhancements and assisting with the product development roadmap
- Working with finance, project management and data science to establish financial forecasting
Provides support and consulting services to Business Development by:
- Meeting and communicating with Business Development regarding new business opportunities and internal capabilities
- Representing the department as it relates to new business; communicating operational commitments to clients as needed
- Attending client meetings and conference calls relating to new business
- Reviewing and contributing to proposals and RFIs related to new business
- Preparing for and formally presenting in capability presentations, bid defense meetings or other client meetings
- Contributing to marketing materials for the Clario web site or collateral for distribution to new clients
Keeps current with therapeutic area developments by:
- Maintaining relationships with key opinion leaders
- Staying abreast of the relevant medical and scientific literature
- Attending and contributing to medical and scientific conferences (abstract submission, invited talks, panel discussions, sessions moderators, etc.)
- Monitoring improvements and innovation in imaging hardware and methods
- Tracking regulatory trends
- Identifying new processes/tools to improve image quality, reading quality or to implement new reading methods
Secondary ResponsibilitiesMaintains Quality Service and Departmental Standards by:
- Reading, understanding and adhering to organizational Standard Operating Procedures ("SOP")
- Reviewing and updating company SOPs related to therapeutic team
- Participating in the establishment and review of departmental standards
Contributes to team effort by:
- Working with internal staff to resolve issues.
- Assisting with training Clario employees in the Therapeutic Area.
- Exploring new opportunities to add value to organization and departmental processes.
- Helping others to achieve results.
- Performing other duties as assigned.
QualificationsEducation:
- Bachelor's Degree with fifteen years of experience in staff management, project management, data management or another relevant technical field.
- Advanced degree, M.S., Ph.D. or MD, preferred
Experience:
- 10+ years clinical trials experience within a CRO or pharmaceutical research organization
- Experience in a controlled or regulated environment (ISO, 21CFR Part 11, GCP/GLP, etc.) required
- Experience in project planning, reporting and financial management
- Experience coordinating staff workflow
- Working knowledge of GCH, ICH guidelines and FDA regulations
- Directly-relevant scientific research experience
- Developed publication record
Additional Skills:
- Strong written and verbal skills
- Strong knowledge of the clinical research, project management and data management process.
- Detail orientation with excellent organizational skills
- Demonstrated communication, presentation and time management skills
- Experience working with computer software including Word and Excel
- Practical and technical knowledge of therapeutic area and related imaging modalities.
- Demonstrated ability to effectively communicate to outside clients and to an internal project team.
- Ability to lead team and direct sponsors.
- Excellent attention to detail and orientation toward meticulous work
- Strong documentation and organizational skills
- Ability to project and maintain a professional and positive attitude
Working conditionsTravel: 15-30%
Lifting: 0-10 lbs.
Other: Computer work for long periods of time
This JOB description should not be deemed all-inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs.
