Manager – Imaging Clinical Trial Management Systems

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 Honor Health, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/Rad Partners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.

Under the direction of Imaging Operations Leadership this position is primarily responsible for configuring and administrating Imaging Endpoints Clinical Trial Management System (CTMS). This role will coordinate with the CTMS vendor and will administrate iCTMS activities related to new CTMS builds, updates to existing CTMS builds, user administration, report development, system enhancements, investigating new scope for automation for system improvements, lay process improvement plans for Imaging Endpoints and general responses to issues experienced by CTMS users.

• Assist with day-to-day administration of CTMS tasks and activities amongst the CTMS team.
• Provide line management to CTMS team including prioritization, mentoring and support.
• Strong problem-solving skills and ability to work independently.
• Provide functional guidance of CTMS application to various stakeholders.
• Access Management for CTMS application to cross functional department as well as stake holders.
• Assist with configuration of new study builds within CTMS application per study specific requirements and configuration management change control requirements.
• Create and deploy automation solutions to ensure process optimization and increase efficiency.
• Demonstrate strategic thinking skills and drive project-based group objectives.
• Assist in the creation and maintenance of training materials for CTMS team.
• Coordinate with Compliance and Regulatory Affairs teams in performing necessary activities for study new builds, study build updates and CTMS software upgrades as well as new feature implementations.
• Assist in the training of internal users on iCTMS.
• Interact with the CTMS vendor in understanding their roadmap and relaying Imaging Endpoints’ requirements.
• Active participation in drafting Company’s Standard Operating Procedures (SOPs) and Working Instructions (WIs) and defining process to ensure the impact is productive.
• Other duties as assigned by the manager

• Bachelor’s degree or equivalent work experience
• Life Sciences, Healthcare and/or Clinical trials experience required.
• Strong experience with CTMS, EDC platform is preferred.
• Sybase, SQL reports, and query writing experience is preferred.
• Proficiency in MS Office and internet applications required.
• Must have strong computer skills.
• 4+ years of experience in the clinical trials or Pharmaceutical industry.
• 2+ years of line management experience.
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred

• Service oriented approach, flexible, and proactive
• Must have superior attention to detail and excellent oral and written communication 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