Associate Director, Clinical Data Management

Imaging Endpoints - Scottsdale, AZ3.0

Full-timeEstimated: $91,000 - $120,000 a year
EducationSkills

Imaging Endpoints (IE) is an Imaging Clinical Research Organization (iCRO) that also provides comprehensive CRO and Site Management Organization (SMO) services for image-centric trials. We are based in Scottsdale, Arizona and are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and an affiliate of Scottsdale Medical Imaging Limited (SMIL), ranked as the 3rd largest private radiology group in the US. Our experience extends from translational to phase III and IV studies and every step in between.

The primary responsibility of the Associate Director of Clinical Data Management is to manage the DM department staff and support the DM Department Head in all aspects of the data management process through the life-cycle of each project.

RESPONSIBILITIES

  • Responsible for all aspects of data management and deliverables across multiple study projects
  • Manage and oversee day-day activities of data management staff and provide training and guidance
  • Provide line management to data management staff
  • Report status of data management activities to executive management
  • Provide input to executive management in the development and budgeting of data management line items in proposals
  • Travel to and participate in due diligence and/or bid defense activities
  • Author DM SOPs as needed
  • Act as the primary interface and collaborate with Imaging Operations, Scientific Affairs and Clinical Research to develop all DM documentation and activities for Study Startup, Conduct and Closeout.
  • Provide clinical and image data management support to the operations team. Support DM leads in their work and reporting to Project Managers (PMs) such DM work is prioritized and accomplished per Company directives
  • Develop and track timelines to ensure data management milestones are met in coordination with the project team
  • Direct and/or author Data Management Plans and maintains them throughout the lifecycle of a project
  • Direct and/or author data management study documentation; for example, edit check specifications, eCRF and database requirements, data QC processes, CRF completion guidelines, data transfer plans, data import plans
  • Develop documentation for UAT of EDC Systems
  • Oversee and/or participate in the execution of UAT
  • Train End-users on data collection tools
  • Lead and/or participate in data cleaning procedures; including issuing & closing queries, presenting tables & listings review
  • Quality review of visual and tabular representations of data in a variety of MS Office products
  • Participate in conference calls, sponsor visits and audits (internal and external) as needed
  • Able to manage multiple projects with shifting priorities within a small company environment
  • Perform other duties as assigned

EDUCATION AND EXPERIENCE

  • Bachelor’s degree in a science related field
  • Minimum of 8-10 years of direct data management experience
  • 5+ years of line management experience in a regulated environment within the medical device, biotechnology, or pharmaceutical industries
  • Exposure to medical imaging considered a plus
  • Working knowledge of Good Clinical Practices, clinical research, clinical trials and related regulatory requirements, industry best practices and terminology
  • Vendor management experience a plus
  • Exposure to the principles of CDISC considered a plus

SKILLS

  • Strong working knowledge of the regulations governing the development of electronic data capture systems
  • Working knowledge of various data capture tools; for example, excel, SAS, SPSS, iMednet, Medidata, Oracle Clinical RDC
  • Strong working knowledge of MS office
  • Demonstrated proficiency initiating and managing clinical data projects
  • Ability to interpret and apply regulatory guidelines and requirements
  • Process-minded individual that constantly strives for perfection
  • Proven ability to function in a complex business and compliance environment
  • Flexible; able to quickly shift gears and respond to changing organizational goals and needs
  • Understand the use and utility of medical imaging in clinical trials
  • Ability to understand technical research protocols and successfully lead within the research environment
  • Ability to communicate effectively one-to-one, in small groups and in public speaking contexts; effective writing as evidenced by precise, well-organized emails, letters and proposals while using appropriate tone, vocabulary and grammar
  • Ability to organize and schedule in an efficient, productive manner; anticipating contingencies and paying attention to detail
  • Self-motivated with ability to work under minimal supervision and aggressive timelines

TRAVEL REQUIREMENTS

  • Approximately 20%

PHYSICAL REQUIREMENTS

  • While performing the duties of this position, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

Imaging Endpoints is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status

Job Type: Full-time

Experience:

  • Data Management: 8 years (Required)
  • Line Management Regulated Environment: 5 years (Required)

Education:

  • Bachelor's (Required)

Work Location:

  • One location