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Director, Clinical Data Management

Company: Cymabay Therapeutics Inc.
Location: Newark
Posted on: February 20, 2021

Job Description:

We are searching for an Associate Director or Director in Clinical Data Management. This individual will be responsible for managing, leading, and overseeing all Clinical Data Management (CDM) planning and operational activities to meet corporate goals, budgets, and timelines. This includes but is not limited to participation in vendor qualification and selection, budget planning and contract negotiations, development of corporate data standards, and training and oversight for all CDM services from study start-up through study close-out, final reporting, and archiving. Additionally, the Director will supervise, manage, and lead the design, implementation and execution of standard CDM processes with vendors. The role reports to Head of Biometrics. Essential Functions and Job Responsibilities:

  • Oversee CRO data management and/or contract data management staff and contributes to the development of clinical data management within the company
  • Formulate short-term and long-term strategies to improve data management efficiencies
  • Cultivate effective and productive working relationships with colleagues, subordinates, vendors, and management as well as solve problems and escalate issues with proposed solutions to senior management as needed
  • Provide leadership and direction for outsourced activities
  • Ensure projects are conducted in compliance with operating procedures, GCP, ICH, Good Clinical data management practices, FDA regulations, and CDISC and FDA submission standards
  • Educate clinical team members as needed regarding data management processes, workflow, and data standards that may have direct impact on their work
  • Implement standardization of data management to complete project deliverables on schedule and according to quality standards and requirements of the study
  • Review and provide feedback on study documents such as study management plans, specifically data management plans, study protocols, Statistical Analysis Plans, CSRs and other documents as required
  • Co-lead vendor and technology evaluation, qualification, and selection
  • Oversee database builds and validation (e.g., EDC's and Interactive response systems) and case report form development
  • Ensure complete and consistent medical term coding using appropriate standard dictionaries
  • Manage reconciliations between clinical and drug safety databases
  • Ensure smooth and successful timely locking of database
  • Ensure timely completion of data management archiving
  • Ensure data management project documentation is in an audit-ready state
  • Lead the development and maintenance of Standard Operating Procedures (SOPs) and Work instructions related to data management activities
  • Responsible for managing and tracking work orders associated with clinical data management activities to ensure that the operating costs for the data management department are achieved within budget
  • Complete other responsibilities as assigned and agreed upon Minimum Qualifications:
    • Bachelor's or Master's degree with minimum of 10+ years of clinical data management experience in pharmaceutical and/ or CRO's
    • Experience in global Phase 3 programs and validation of database for NDA submission
    • In-depth knowledge of FDA regulations, GCP, GCDMP, CDISC, and ICH guidelines
    • In-depth knowledge of clinical trial process, EDC systems (i.e. Medidata Rave, InForm, etc.), database programming, clinical operations, quality management, and systems applications to support operations
    • Successful management of and good working relationship with outside vendors
    • Complex and international trails experience desired
    • Proficiency in the data management processes
    • Excellent written and oral communication skills with the ability to communicate clearly to all organizational levels
    • Must be able to work productively in a fast-paced collaborative environment
    • Work well in a collaborative team environment, and have good organizational, communication and interpersonal skills How did you hear about our company and this job opening? Are you legally authorized to work in the United States?* Will you now or in the future require sponsorship for employment visa status? (e.g., H-1B visa status?* Are you able to perform the essential job functions of the job for which you are applying, either with or without reasonable accommodation?* If no, describe the functions that cannot be performed. If hired, what date can you start work?*

Keywords: Cymabay Therapeutics Inc., Newark , Director, Clinical Data Management, Executive , Newark, New Jersey

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