Senior Manager/Director

Our client, a full-service cardiovascular clinical research organization is currently seeking a Senior Manager/Director of Core Lab Operations to join their team. This person will be responsible for managing all aspects of cardiovascular imaging in phase I-III clinical trials, including project management leadership in pre-trial functions  of operational design/planning, day-to-day management of clinical trials, and overseeing the imaging team.

Responsibilities:

  • Programmatic development of operational infrastructure, including site and study management, development of imaging charters, and data management systems and structure
  • Support the development of new study proposals with emphasis on the imaging aspect

  • Act as the subject matter expert for the Core Laboratory in client meetings pre- and post-contract including bid defenses

  • Outlining requirements of the operational set-up for trials, including data transfer and administration, site training and certification, IT infrastructure

  • Manage and oversee ongoing clinical trial operations associated with imaging including participation in DSMB meetings, coordinating multiple investigators and institutions, site management, imaging data management, clinical trials documentation such as trial operations manuals, and EDC systems and reporting as well as IRB aspects

  • Communication with clinical sites and imaging core labs on processes and deliverables to ensure timelines are met, using trial metrics

  • Ensure core lab processes are conducted in accordance to ICH/GCP standards including multiple regions in global trials

  • Supervise quality assurance efforts, including the development and revision of Standard Operating Procedures, adherence to regulatory requirements, hosting client and regulatory audits and responding to audit findings in collaboration with the head of Quality Management Services

Qualifications:

  • Bachelor’s degree in a technical, scientific, or healthcare field is required. Graduate degree in a technical, scientific, or healthcare field, or in business administration, is preferred

  • 6-8 years total experience with a minimum of 5 years of experience in the Biotechnology, Pharmaceutical or Imaging industry or Academic Centers

  • Minimum of 2 years of experience as a manager for imaging related clinical trials

  • Willing to learn study related FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies

  • Understanding of Standard Operating Procedures, regulatory audits, IRB regulation and clinical trials documentation requirements

  • Understanding of electronic data capture (EDC) systems and reporting/exporting data

  • Knowledge of DICOM data transfer, image receipt, and image quality assessment

  • Experience in at least one CV imaging modality combined with interest and experience in software, hardware, and management of imaging aspects including IT will be essential

  • Experience in managing industry and academic clinical trials is desirable

 

If you are interested in this position, please send your resume to apowell@daleyaa.com

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