Manager Imaging Operations

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial’s imaging to optimize the opportunity to demonstrate efficacy.

Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL / RadPartners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.

The Manager, Imaging Operations is primarily responsible for line management of the Clinical Trial Imaging Specialist (CTIS), Read Assignment (RA) CTIS, and Project Associate Operations staff. Under the direction of Imaging Operations / Project Management Leadership, the Manager, Imaging Operations shall provide strategic direction to the CTIS, RA CTIS and Project Associate operations team, mentor and lead the clinical operations team and ensure adherence to quality management practices.

RESPONSIBILITIES

Oversee and Lead the Imaging Operations staff of CTIS, RA CTIS and Project Associate by providing training and mentoring to ensure efficient work product

Develop detailed training plan for the staff to ensure new staff is consistently trained and supported for success

Oversee and / or manage day-to-day operations aspects of operational projects, including coordination of daily work assignments for direct reports as per departmental deliverables, deviation management, image reconciliation, and image submission portal development.

Identifies and escalates personnel issues to operational leadership and / or Human resources

Provide insight to the operational team resourcing needs and approval of staff time off requests.

Facilitates team meetings to promote inter departmental collaboration, knowledge sharing and Company Goals and Objective initiatives.

Report on project status to client and management

Work with executive management in identifying backlog and upcoming work and planning operational resources to support the study needs

Support Associate Managers in their work, and the work of their direct reports, to ensure their work is prioritized and accomplished per Company directives

Develop and monitor staff and departmental quality metrics

Work with department head to maximize monthly revenue and minimize operations costs

Work with finance and executive management to review forecast and track revenue and expenses, and maximize monthly revenue and minimize operations costs

Continually evaluate current systems (CTMS, AG Mednet, OSIRx, etc.) and processes to identify and implement improvements and bring in efficiencies for better work experience for the staff

Partner with operations leadership to develop staff, structure department, and create a highly desired work environment for attracting and retaining highly qualified clinical operations professionals

Provide leadership and direction to the operational and cross functional teams to promote a collaborative and solution minded approach to operational challenges

Manage the Operations image processing team to ensure adherence to and compliance with applicable state, federal and international regulations, and guidance from regulatory agencies

Manage the development, maintenance of, and adherence to operations SOPs

Assist IT with the development, validation, operation, and controlled state of IT systems as it relates to Operational image processing tasks

Hire, conduct performance reviews, and professional development plans for direct reports

Work with department head to maximize monthly revenue and minimize operations costs

Participate in discussions with Contract Research Organizations and vendors as needed to manage operational delivery

Lead the clinical operations team in executing project plans and collaborating with the project management team as appropriate to meet the changing needs and requirements of sponsor and company

Participate in client presentations, audits and / or bid defense meetings, as required

Perform other duties as assigned by the supervisor

EDUCATION AND EXPERIENCE

Bachelor’s degree or equivalent experience related to assigned responsibilities

Minimum of 5 years’ experience in the medical or clinical trials industry is preferred (other healthcare or related experience is also an asset)

Minimum of 3 years prior lead, management experience or senior level position

Clinical operations experience working in Phase I-IV global clinical trials a plus

Knowledge of Good Clinical Practice (GCP), Quality Assurance / Compliance in a clinical trials setting is preferred

SKILLS

Provide staff with appropriate coaching, mentoring, and development

Hands-on ability to think tactically and strategically

Proficiency in MS Office and internet applications

Service-oriented approach, flexible, and proactive toward adapting to client needs

Ability to manage project activities with diverse group and individuals with little supervision

Must have superior attention to detail including excellent oral and written communication skills.

Must have the ability to work independently, multitask, and meet critical timelines under pressure

Must have strong time management and organization skills

Self-driven, ability to get the job done with little supervision, can-do positive attitude

Ability to excel in a team environment

Ability to work in strict compliance with all procedures, rules, and regulations

Maintain strict confidentiality of sensitive data, records, files, conversations, etc.

Must be self-motivated and able to grasp new concepts quickly

Ability to prioritize workload to the changing needs of the day-to-day business

Ability to understand technical research protocols and successfully lead within the research environment

IMAGING ENDPOINTS’ TEAM CHARACTERISTICS

Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imaging

Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging

Commitment and caring for our fellow team members, their families, and the communities IE serves - see Caring Endpoints : and high ethical standards; we always do the right thing

High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives

Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day’s objectives while striving to improve ourselves and IE everyday

Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success

High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else

PHYSICAL REQUIREMENTS

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

Travel : Up to 10-15% (domestic and / or international)