Senior Director, Technical and Data Operations

New Haven, Connecticut, United States | Full-time

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Job Description: 

The Senior Director of Technical and Data Operations will lead data operations and analytics activities in support of Invicro studies across all service lines and is responsible for the systems and applications used by the Core Lab in the day to day execution of Core Lab projects. This includes functional execution in addition to strategic planning for scalability to support new service lines and offerings. He/she will ensure that data captured, systems used, and processes implemented will ensure accurate, consistent, high-quality data with a focus on efficiency and on-time delivery.  As such the position will interact with internal software and operations teams to guide development and work directly with third party providers to integrate third party software with internal systems.  The Senior Director of Technical and Data Operations will also be responsible to work across the Core Lab to improve efficiency through process enhancement and software-based automation.

 

Responsibilities:

  • Works with operations to use new technologies to streamline company processes with a focus for use in clinical research studies.
  • Develop a roadmap for current technologies integrating requirements to support late phase clinical research studies.
  • Integrate third-party tools as required to meet objectives of clients and better integrate data sources for efficiency, quality and faster access.
  • Evaluates new technology and makes recommendations on technological solutions
  • Ensure that development and integration of new technology assets meet the regulatory and quality requirements of regulatory agencies.
  • Routinely evaluates technical efficiency and makes changes as necessary
  • Identifies competitive advantages and technological trends for the benefit of the company
  • Build and manage a steering committee to ensure that objectives and requirements for new technologies are on target with business and operational objectives.
  • Create and enforce policies (SOPs, WIDs) for effective quality driven data management
  • Provide input into processes and tools for quality data acquisition to ensure adequacy, accuracy and legitimacy of data
  • Devise and implement efficient and secure procedures for data handling and analysis with attention to all technical aspects
  • Establish rules and procedures for data sharing with internal team, upper management, external stakeholders etc.
  • Oversee standard and ad-hoc report development with input from operational stakeholders and close collaboration with Image Analysis and Software departments
  • Oversee the Software Compliance team with a focus on quality and independence
  • Oversee data review for sponsor inquiries, quality issues and general data trends; generate outlier reports to support efficient review as necessary
  • Ensures data integrity (including 21 CRF Part 11 compliance where applicable) of research data, software, and reports
  • Prepares data components in support of regulatory and/or client submissions.
  • Support business development in RFI/RFP process to ensure representation of capabilities
  • Support audits and inspections as required by the business

 

Skills:

  • Proven experience as a technology leader or similar role
  • Knowledge of technological trends to build strategies in support of imaging endpoints for clinical research studies
  • Understanding of budgets and business-planning
  • Ability to conduct clinical trial technological analyses and research
  • Excellent communication skills
  • Leadership and organizational abilities
  • Experience in building strategies to build market share with a goal to be a market leader.
  • Problem-solving aptitude
  • Excellent understanding of data administration and management functions (collection, quality control, analysis, distribution etc.)
  • Strong understanding of clinical trial documents (protocols, source documents, CRFs) and regulated processes
  • Strong understating of Software Compliance and Software Development Lifecycle (SDLC)

 

Education and Experience:

  • BS or higher degree in technical or scientific discipline that lends itself to advanced data processing with a focus in medical imaging.
  • 5+ years’ experience in building and developing the technology infrastructure required to support imaging requirements for clinical research studies.
  • Experience building and managing imaging core labs preferred. This includes developing all the necessary SOPs, documentation requirements, quality systems, Engineering/Development and Validation processes, and technical support.
  • Experience leading and managing large highly technical groups (i.e. data management, development, IT, engineering and quality management).
  • Experience with 21 CFR part 11 and developing applications that require compliance with the regulation.
  • Architect/Manager of a development team for web-based workflow management and data transfer systems used to support imaging studies for clinical research.
  • Experience developing and validating image analysis systems in support of clinical research studies
  • Experience with designing and implementing the framework for core lab workflow management systems
  • Experience with image data formats and more specifically DICOM medical imaging formats and how to overcome variations inherent in the standard.

 

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.