Imaging Operations Manager

$112,000 - $186,600/Yr

Quintiles - Durham, NC

Part-time - Mid Level

Durham, NC

Ambulatory Health Care Services

About the position

The Imaging Operations Specialist is responsible for the operational implementation of imaging strategies for assigned clinical studies, ensuring compliance with sponsor processes and regulatory requirements. This role involves collaboration with Clinical Trial Teams (CTTs) to manage imaging-related activities, negotiate with CROs, and ensure timely execution of imaging components in clinical trials.

Responsibilities

• Support individual clinical trial teams (CTTs) for all imaging-related matters for assigned studies.
• Attend Clinical Trial Team and other trial meetings as applicable.
• Prepare Imaging Study Specifications Worksheet (ISSW) to negotiate and manage requirements and costs with CROs.
• Provide input on imaging sections in clinical trial-related documents with guidance from Medical Lead and Global Trial Director.
• Manage the imaging CRO interface with the CTT, including leading the imaging CRO meetings.
• Contribute to the preparation and review of key documents, including imaging manual, imaging charter, and data transfer specifications.
• Support the tracking and collection of missing scans in collaboration with the imaging CRO, CTT, and GDO Trial Monitoring.
• Track and ensure adherence of imaging CRO to critical imaging-related milestones, including timely delivery and quality of central review results.
• Define imaging needs for case report forms and data transfer in collaboration with the CTT and imaging CRO.
• Liaise with the trial data manager and imaging CRO for data transfer, data reconciliation, and querying as needed.
• Develop site and monitor training material in partnership with imaging CRO.
• Provide training to CTTs on trial imaging-related aspects and contribute to the standardization of documents.

Requirements

• BS degree or higher in imaging or related life-sciences.
• 3 to 5 years of relevant experience in executing imaging strategies in clinical trials.
• Familiarity with a broad range of imaging techniques.
• Preferred experience in CRO management or CRO environment, and an understanding of imaging CRO capabilities.
• Strong operational skills and problem-solving attitude with a focus on quality.
• Proven interpersonal skills including effective communication with individuals and groups.
• Experience establishing and maintaining effective relationships with internal and external team members.
• Ability to meet deadlines under stressful situations.

Nice-to-haves

• Experience in training monitors and site personnel.
• Knowledge of clinical trial processes and regulations.

Benefits

• Health insurance
• Incentive plans
• Bonuses
• Health and welfare benefits