Director/Senior Manager Of Core Lab Operations

Help build a strong CORE !

Our Boston based CRO, a scientific leader in cardiovascular translational and clinical studies, is pumping up their Core Lab structure and you can be the heart of the effort.

 

Position Description:

Successful 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, including 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 functional link between sites, imaging core labs, and sponsors.

 

Responsibilities:

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

Pre-trial

·         Act as the SME for the Core Lab in client meetings pre- and post-contract including bid defenses

·         Contribute imaging aspects to new study proposals to the CEO, CFO and Project Team

·         Define requirements of the operational set-up for trials: data transfer and administration, site training and certification, IT infrastructure

Day-to-Day Trial Management

·         Daily management of clinical trial operations associated with CV imaging

·         Participate in DSMB meetings, coordinate multiple investigators and institutions, site management, imaging data management, all clinical trials documentation eg 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

·         Communicate with internal team, clinical sites, and imaging core labs on deliverables and processes to ensure timelines are met, using trial metrics

·         Monitor 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

Program development

·         Supervise quality assurance efforts, including developing/revising  Standard Operating Procedures, ensure 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 MS Office, esp Word and Excel

·         Leadership – effectively manage team tasks and timelines, interface with sponsors and outside collaborators

·         Work as part of a team and interact collaboratively with individuals with various backgrounds and education

·         Know/learn study related FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies

·         Understand Standard Operating Procedures, regulatory audits, IRB regulation and clinical trials documentation requirements

·         Understand 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 send CV to Monica Sabia at msabia@daleyaa.com

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