Director/Senior Manager of Core Lab Operations:

Our Boston- based client is a leading clinical trials research organization with scientific leadership in translational and clinical studies using cardiovascular imaging in fields such as heart failure and acute myocardial infarction and they are looking to add a key management role to their team

Position Description:
The candidate will manage all aspects of cardiovascular imaging in phase I, II, and III clinical trials as well as the development of an advanced cardiovascular imaging core. This includes project management leadership in pre-trial functions of operational design and planning, development of protocols and budgets; day to day management of clinical trials overseeing the imaging team, and being a key in the interaction between sites, imaging core labs, and sponsors.

 

Responsibilities:
Relevant activities include, but are not limited to the following:

Pre-trial 

  • Act as the subject matter expert for the Core Laboratory in client meetings pre- and post-contract including bid defenses
  • Work with the CEO, CFO and Project Team in the development of new study proposals with emphasis on the imaging aspect
  • Outlining requirements of the operational set-up for trials, including data transfer and administration, site training and certification, IT infrastructure

Day-to-Day Trial Management 

  • Day to day management of clinical trial operations associated with CV imaging
  • 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. Coordinate the support of technical systems, including internal IT systems, image tracking system, and other IT, software, hardware applications supporting the trial
  • Supervise data QA/QC, lead data transfer to internal/external collaborators and sponsors
  • Communication with internal team members on deliverables and ensuring timelines are met, using trial metrics
  • Communication with clinical sites and imaging core labs on processes and deliverables to ensure timelines are met, using trial metrics
  • Monitoring of core laboratory data to ensure timely entry and readiness for data review meetings
  • Ensure core lab processes are conducted in accordance to ICH/GCP standards including multiple regions in global trials
  • Ensure that project deliverables are aligned with contracted budget and report monthly deliverables to the CFO for appropriate billing activities

Programmatic development 

  • 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
  • Site and study management, development of imaging charters, and data management systems and structure as related to core laboratory functions

Skills and Competencies:

  • Works independently, able to learn and understand organizational efficiencies and hierarchies
  • Knowledge of computer-based software programs such as Excel, MS Office, and MS Word etc.
  • Leadership skills to effectively manage team tasks and timelines, interface with sponsors and outside collaborators
  • Ability to work within a team and interact collaboratively with individuals with various backgrounds and education
  • Willing to learn study related FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
  • Understand of Standard Operating Procedures, regulatory audits, IRB regulation and clinical trials documentation requirements
  • Understand of electronic data capture (EDC) systems and reporting/exporting data
  • Knowledge of DICOM data transfer, image receipt, and image quality assessment.
  • Excellent organizational and project management skills

Experience:

  • 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

If interested, please email Earl Callender at ecallender@daleyaa.com

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