Manager / Senior Manager - Change and Project Management

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 / Senior Manager, Change and Project Management is responsible for overseeing contract amendments and change orders. This role will provide ongoing training and support to the Project Management team and other departments as needed, as related to amendments and change orders. The Senior Manager, Change and Project Management is also responsible for working with sponsors to confirm assumptions related to changes in the contract and to liaise with the appropriate staff to communicate changes in the client’s contract and / or work order. This role may also oversee a team working on contract amendments and change orders.

RESPONSIBILITIES

Guide direct reports and provide training and support to the Project Management team and other departments (as needed) in relation to contract amendments and change orders.

Line management of a team that will assist with contract amendments and change orders.

Assist in preparation and adherence of contract amendments and change orders, including alignment with imaging trial documents i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, and other study specific documents.

Ensure contract amendments and change orders are complete, current, and have been tracked and stored appropriately.

Oversee process improvements to the Contract amendments and change orders process.

Monitor and improve turnaround times for the delivery of amendments and change orders to sponsor contacts

Identify out of scope requests and work with appropriate team(s) to revise the work order to meet changing needs and requirements.

Prepare metrics reporting for client and senior management.

Prepare forecasting information for Finance purposes.

Travel to and participate in due diligence and / or bid defenses, capabilities presentations, and conferences as needed.

Participate in providing details required for RFIs upon request.

Work closely with the Head of Project Management and Imaging Operations departments to assist with the SOP / WI updates as required based on the new processes / gaps that are identified on an on-going basis.

Provide mentoring and support to Project Managers and other departments (as needed) by creating training materials and providing training specific to :

Billing and Forecasting

Contract Change Management

New hire onboarding

Other trainings as needed

Other Project Management tasks as identified

Perform other duties as assigned by the Supervisor.

EDUCATION AND EXPERIENCE

Bachelor’s degree or equivalent experience in a health-related field or clinical trials

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

Proficiency in MS Office and internet applications required

Minimum of 5-7 years of experience in the clinical trials industry required

Minimum of 2-3 years of experience in medical imaging clinical trial industry required

Experience managing global Phase III clinical trials with imaging components required

SKILLS

Superior attention to detail, particularly in written documentation

Service oriented approach, flexible, and proactive

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

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 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 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.

PHYSICAL REQUIREMENTS

Estimated 5-15% travel (domestic and international)