SUMMARY
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 Associate Manager / Manager / Senior Manager, Clinical Operations is primarily responsible for line management and delegation of project assignments to the Clinical Project Coordinator (CPC) team. Under the direction of Imaging Operations Management Leadership, this position shall provide guidance and direction of the functional activities to the CPC operations team, mentor and lead the clinical operations team.
ASSOCIATE MANAGER, CLINICAL OPERATIONS
RESPONSIBILITIES
- Coordinates onboarding training to new Clinical Project Coordinators and ongoing training as needed
- Oversees and assists in the coordination of daily work assignments for direct reports as directed by department management
- Identifies and escalates personnel issues to operational leadership and/or Human resources
- Facilitates team meetings to promote inter departmental collaboration, knowledge sharing and Company Goals and Objective initiatives.
- Monitors site evaluation process for all studies
- Monitors status of Trial Master Files of all studies to ensure audit preparedness
- Monitors status of completion of tasks required for studies to be ready to QC and ready to read
- Monitors study closure activities to ensure timely completion of close-out activities
- Monitors study specific training of studies and coordinates with direct reports to ensure timely initiation of study team training
- Monitors direct reports to ensure timely updates to project trackers and entries of enrollment updates into iCTMS
- Leads direct reports to identify and develop systems that enhance department efficiency
- Partners with department management to develop staff, structure department, and create a highly desired work environment for attracting and retaining highly qualified clinical operations professionals
- Manages direct reports to ensure adherence to and compliance with applicable state, federal, and international regulations, accreditation requirements, and guidance from regulatory agencies
- Manages the development, maintenance of, and adherence to clinical operations SOPs
- Provides updates on assigned tasks to department management
- Participates in audits as needed
- Conducts performance reviews and prepares professional development plans for direct reports
- Manages scheduling out of office time and back-up coverage for direct reports
- Participates in interview process for potential new hires
- Performs other duties as assigned by supervisor
EDUCATION AND EXPERIENCE
- Bachelor’s degree or equivalent experience related to assigned responsibilities
- Experience in the medical or clinical trials industry is preferred (other healthcare or related experience is also an asset)
- Minimum of 2 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
MANAGER, CLINICAL OPERATIONS
RESPONSIBILITIES
- Coordinates onboarding training to new Clinical Project Coordinators and ongoing training as needed
- Oversees and assists in the coordination of daily work assignments for direct reports as directed by department management
- Identifies and escalates personnel issues to operational leadership and/or Human resources
- Facilitates team meetings to promote inter departmental collaboration, knowledge sharing and Company Goals and Objective initiatives.
- Monitors site evaluation process for all studies
- Monitors status of Trial Master Files of all studies to ensure audit preparedness
- Monitors status of completion of tasks required for studies to be ready to QC and ready to read
- Monitors study closure activities to ensure timely completion of close-out activities
- Monitors study specific training of studies and coordinates with direct reports to ensure timely initiation of study team training
- Monitors direct reports to ensure timely updates to project trackers and entries of enrollment updates into iCTMS
- Develop and monitor staff and departmental quality metrics
- Support Associate Managers in their work, and the work of their direct reports, to ensure their work is prioritized and accomplished per Company directives
- Leads direct reports to identify and develop systems that enhance department efficiency
- Partners with department management to develop staff, structure department, and create a highly desired work environment for attracting and retaining highly qualified clinical operations professionals
- Assist IT with the development, validation, operation, and controlled state of IT systems as it relates to Operational tasks
- Manages direct reports to ensure adherence to and compliance with applicable state, federal, and international regulations, accreditation requirements, and guidance from regulatory agencies
- Manages the development, maintenance of, and adherence to clinical operations SOPs
- Provides updates on assigned tasks to department management
- Participates in audits as needed
- Conducts performance reviews and prepares professional development plans for direct reports
- Manages scheduling out of office time and back-up coverage for direct reports
- Participates in interview process for potential new hires
- Performs other duties as assigned by supervisor
EDUCATION AND EXPERIENCE
- Bachelor’s degree or equivalent experience related to assigned responsibilities
- Minimum of 3 years 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
SENIOR MANAGER, CLINICAL OPERATIONS
RESPONSIBILITIES
- Coordinates onboarding training to new Clinical Project Coordinators and ongoing training as needed
- Oversees and assists in the coordination of daily work assignments for direct reports as directed by department management
- Identifies and escalates personnel issues to operational leadership and/or Human resources
- Facilitates team meetings to promote inter departmental collaboration, knowledge sharing and Company Goals and Objective initiatives.
- Monitors site evaluation process for all studies
- Monitors status of Trial Master Files of all studies to ensure audit preparedness
- Monitors status of completion of tasks required for studies to be ready to QC and ready to read
- Monitors study closure activities to ensure timely completion of close-out activities
- Monitors study specific training of studies and coordinates with direct reports to ensure timely initiation of study team training
- Monitors direct reports to ensure timely updates to project trackers and entries of enrollment updates into iCTMS
- Develop and monitor staff and departmental quality metrics
- Support Associate Managers and Managers in their work, and the work of their direct reports, to ensure their work is prioritized and accomplished per Company directives
- Leads direct reports to identify and develop systems that enhance department efficiency
- Partners with department management to develop staff, structure department, and create a highly desired work environment for attracting and retaining highly qualified clinical operations professionals
- Assist IT with the development, validation, operation, and controlled state of IT systems as it relates to Operational tasks
- Manages direct reports to ensure adherence to and compliance with applicable state, federal, and international regulations, accreditation requirements, and guidance from regulatory agencies
- Manages the development, maintenance of, and adherence to clinical operations SOPs
- Provides updates on assigned tasks to department management
- Participates in audits as needed
- Conducts performance reviews and prepares professional development plans for direct reports
- Manages scheduling out of office time and back-up coverage for direct reports
- Participates in interview process for potential new hires
- Performs other duties as assigned by 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 5 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 more information about Caring Endpoints at https://caringendpoints.org/
- Integrity 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
- 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
Travel: 15-20% (domestic and/or international)
