Medical & Scientific Affairs Advisor

Clario is a 50+ year old company that delivers industry leading clinical trial endpoint technology solutions. The future of clinical trials is vibrant, with new technologies revolutionizing what’s possible. From new trial modes to faster and integrated evidence and findings, our innovative clinical trial solutions mean we can unlock better evidence.

What we offer:

• Competitive compensation
• Medical, dental, and vision insurance beginning Day 1 of employment
• Flexible work schedules
• Attractive PTO plan
• Engaging employee programs
• Remote working

What you’ll be doing:

Serves as imaging advisor supporting company operations and initiatives by:

Providing support for dedicated therapeutic areas, including:

• Input on the trial design, review methodology and quality control of image data
• Management of processes used to evaluate and enhance the independent review
• Assess trends in independent review metrics, including:
  • Developing benchmarks for reviewer performance
  • Identifying areas of risk within reviewer performance
  • Researching and recommending imaging software that meets project requirements and supports reviewer performance

• Review, report, and inform industry trends related to independent review to maintain Clario leadership in this service
• Foster knowledge about the evaluation paradigms for internal and external parties.

Other responsibilities may include supporting Clinical Adjudication by:

• Reviewing study requirements and endpoint definitions and collaborate with key stakeholders to develop associated study documents (e.g. adjudication charter and clinical site manual)
• Collaborating with Clinical Adjudication Project Manager to provide training materials to endpoint committee
• Developing documentation supporting creation of electronic adjudication case report forms
• Collaborating with Adjudication team management on formatting of White papers
• Updating and writing of SOPs for clinical adjudication

Supports Director, Medical Affairs by:

• Overseeing the execution and documentation of the CMO Review process
• Implementing training standards as it relates to new radiologists, study specific needs, new criteria, etc.
• Assisting in the creation and development of applicable research papers and editorials
• Identifying innovations for central read efficiencies and interpretation techniques
• Creating and/or reviewing documentation including imaging manuals, charters, study specific rules, etc.
• Interpreting and developing operational strategies for new imaging criteria
• Assist in the execution of specialized client project requests including study case image presentations
• Review and engage with clients by providing regulatory input for protocol, charters and data queries
• Consult with application development team of charter content to business requirements

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

Provides supervisory functions by

• Communicating job expectations
• Planning, monitoring and appraising job results
• Coaching and mentoring other team members
• Initiating, coordinating and enforcing systems, policies and procedures
• Assist in the performance evaluations for team members and providing valuable input on proficiency and key areas for growth
• Working with Director, Medical Affairs in the continued development, coordination and implementation of team member functions, training programs and evaluation for change

Secondary Responsibilities

Manages assigned department initiatives by

• Researching, evaluating and becoming Subject Matter Expert (SME) in assigned processes
• Researching and implementing measures to streamline processes
• Establishing process protocol and related communication

• Training new hires on applicable processes and monitoring progress
• Re-training current staff on applicable processes when necessary

Maintains Quality Service and Departmental Standards by

• Reading, understanding and adhering to organizational Standard Operating Procedures (SOP)
• Establishing and enforcing departmental standards
• Reviewing and updating company SOPs related to Oncology Imaging Services

Contributes to team effort by

• Exploring new opportunities to add value to organization and departmental processes
• Helping others to accomplish results

Qualifications:

Education:

• Bachelor’s Degree required
• Advanced degree a plus

Experience:

• 5 + years’ experience working with clinical trials and/or within pharmaceutical environment required
• Experience with multi-modality imaging projects required
• Experience with medical imaging software a plus
• Experience working with computer software including Word, Excel, Access and Project preferred

Additional skill set:

• Ability to work in group setting and independently; ability to adjust to changing priorities
• Strong motivational skills and abilities – promoting a team-based approach
• Strong interpersonal and communication skills, both verbal and written
• Strong organizational skills and leadership skills
• Goal oriented
• Ability to project and maintain a professional and positive attitude

Working conditions:

Travel:  10-20%

Lifting:  0-15lbs

Other:  Computer work for long periods of time

This position 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.