Imaging Core Lab Manager

Overview We are seeking a dynamic and highly organized Imaging Core Laboratory Manager to lead and oversee our core laboratory operations. This pivotal role involves managing laboratory workflows, ensuring compliance with regulatory standards, and maintaining high-quality research and clinical testing procedures. The ideal candidate will possess strong leadership skills, extensive laboratory experience, and a passion for advancing scientific discovery through meticulous management of laboratory activities. As a Core Lab Manager, you will play a vital role in supporting research initiatives, clinical trials, and diagnostic services with efficiency and precision. Core Laboratory Manager Position Summary Cardiovascular Clinical Sciences (CCS) is seeking an experienced and highly organized Core Laboratory Manager to lead the day-to-day operations of our cardiovascular imaging core laboratory while serving as the lead coordinator for assigned clinical trials. Reporting to the Director of Core Laboratory Operations, this newly created role combines operational leadership with hands-on study execution in a true player-coach capacity. The Core Laboratory Manager will oversee study startup, workflow management, sponsor and vendor communications, quality compliance, and process improvement initiatives while ensuring successful delivery of core laboratory services across multiple cardiovascular clinical studies. About the CCS Imaging Core Lab The CCS Imaging Core Lab supports global cardiovascular clinical trials through centralized image collection, analysis, and interpretation. Partnering with pharmaceutical, biotechnology, medical device, and academic sponsors, we provide scientifically rigorous imaging assessments that support clinical development and regulatory programs. Our team works across multiple cardiovascular imaging modalities, including echocardiography, vascular ultrasound, cardiac MRI, and CT, delivering high-quality, standardized evaluations through robust quality systems and industry-leading expertise. Key Responsibilities Core Laboratory Operations Manage daily core laboratory operations across multiple studies. Develop and maintain study workflows, playbooks, SOPs, and best practices. Oversee study startup activities, including laboratory manuals, data transfer plans, and site support materials. Monitor timelines, deliverables, performance metrics, and operational risks. Drive process improvements to enhance efficiency, quality, and scalability. Clinical Trial Execution Serve as lead Core Laboratory Coordinator for assigned studies. Manage study activities from startup through closeout. Coordinate site onboarding, training, and laboratory readiness. Act as the primary operational contact for sponsors, sites, and vendors. Oversee data transfers, reconciliations, issue resolution, and study tracking. Participate in sponsor meetings, investigator meetings, and project team reviews. Vendor, Sponsor & Quality Management Manage relationships with sponsors, sites, and specialty vendors. Ensure compliance with

GCP, ICH

guidelines, sponsor requirements, and applicable regulations. Support audits and inspection readiness activities. Monitor quality metrics and implement corrective actions when needed. Promote a culture of quality, accountability, and continuous improvement. Leadership & Strategic Support Provide mentorship and guidance to coordinators and operational staff. Assist with resource planning, workload management, and departmental growth. Partner closely with the Director of Core Laboratory Operations to implement strategic initiatives and scalable processes. Contribute to proposals, feasibility assessments, and business development efforts. Qualifications Required Bachelor's degree in Life Sciences, Clinical Research, Healthcare Administration, Clinical Laboratory Science, or related field. 5+ years of core laboratory and/or clinical trial operations experience. 3+ years of study coordination or clinical trial management experience. Experience supporting multicenter clinical trials from startup through closeout. Familiarity with imaging platforms (e.g., TomTec, MIMS), secure data transfer systems, EDC platforms, and associated validation processes. Strong knowledge of

GCP, ICH

guidelines, and clinical research regulations. Experience working directly with sponsors, investigators, sites, and vendors. Excellent project management, organizational, communication, and problem-solving skills. Preferred Advanced degree (MS, MPH, MBA, or related field). Experience in cardiovascular clinical research. Prior CRO experience. Why Join CCS? This is a unique opportunity to help build and scale a growing cardiovascular imaging core laboratory while working alongside industry-leading physicians, scientists, and research professionals. The successful candidate will have a direct impact on clinical trials that advance innovative cardiovascular therapies and improve patient outcomes worldwide. At CCS, we value scientific excellence, operational rigor, collaboration, and entrepreneurial thinking.

Pay:

$90,000.00 - $110,000.00 per year

Benefits:

401(k) Dental insurance Flexible spending account Health insurance Paid time off Retirement plan Vision insurance

Work Location:

Hybrid remote in Boston, MA 02111