Primary Responsibilities

Serves as Director supporting company operations and initiatives 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

Specific tasks to support these responsibilities are described below

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 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 Board 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
• Monitors delivery metrics and trends (including reader agreement) to provide continual ongoing improvement to the department
• Assessing workload capacity and developing a resource plan to ensure adequate staffing based on business needs
• 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 to establish financial forecasting

Assists other Clario departments by:

• Implementing and executing training for business analysts, radiologists, QC techs, project management and data management and external readers for image acquisition, reading and reporting
• Assisting in the interpretation and operationalization of new imaging criteria including mentoring business analysts
• Providing Subject Matter Expert support
• Collaborating with Product Development, Validation Services, Data Management on aspects of system requirements

• Providing input to the product development team to define enhancements and new features
• Developing a deep understanding of business processes and product functionality
• Understanding the unique needs of the imaging business units

Provides support and consulting services to Business Development by:

• Meeting and communicating with Business Development regarding new business opportunities and internal capabilities
• Reviewing and contributing to proposals and RFIs related to new business
• Preparing for and presenting in capability presentations, bid defense meetings or other client meetings
• Contributing to marketing materials for the Bioclinica 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

Provides team leadership by

• Leading by example with professional and collaborative conduct
• Developing and mentoring team members
• Establishing team performance expectations and guidelines
• Establishing a work environment conducive to team member growth and development

Performs supervisory functions by:

• Communicating job expectations
• Planning, monitoring and appraising job results
• Coaching, counseling and disciplining staff
• Initiating, coordinating and enforcing policies and procedures
• Approving direct reports time sheets, requests for time off and/or overtime
• Performing timely performance evaluations of direct reports
• Coordinating and conducting new hire interviews; facilitating hiring decision
• Training new hires on departmental processes and responsibilities
• Training and coaching staff to function in their current role as well as developing them for future career advancement within the organization.

Secondary Responsibilities

Maintains 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

Qualifications:

Education:

• MD or PhD Degree in the sciences
• 5 years of experience in medical imaging and clinical trials

Experience:

• 5+ years clinical trials experience within a CRO or pharmaceutical research organization
• Experience in respiratory imaging, rare diseases and or pediatric conditions utilizing MR, CT, Xray and or Ultrasound
• Experience working 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

Additional skill set:

• Strong written and verbal skills (bilingual capabilities is a plus)
• Strong knowledge of the clinical research, project management and data management process.
• Detail oriented with excellent organizational skills
• Demonstrated communication, presentation and time management skills
• Experience working with computer software in the office environment (Word, Excel, PowerPoint, Outlook, time reporting software, etc.)

Working conditions:

Travel: 15-30%

Lifting: 0-10lbs

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.

EEO Statement

Clario is an equal opportunity employer. Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.