Clinical Operations Manager

SUMMARYImaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the Cure. 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 (SMIURadPartners), 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 I Manager I 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. MANAGER, CLINICAL OPERATIONS RESPONSIBILITIESCoordinates 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 iCTMSDevelop 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 SOPsProvides 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 supervisorEDUCATION AND EXPERIENCEMinimum of 3 years' experience in a CROMinimum of 3 years' experience managing a team

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 preferredSKILLSProvide 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 environmentIMAGING ENDPOINTS' TEAM CHARACTERISTICSPassion to Connect Imaging to the Cure 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 elsePHYSICAL REQUIREMENTSWhile 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)