Director, Clinical Data Management

Location: Emeryville, CA
Department: Clinical Development - Fintepla

Summary

The Director, Clinical Data Management is 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 or his/her direct report(s) will supervise, manage, and lead the design, implementation, and execution of standard CDM processes with vendors. This position will report to Head of Biometrics.

Responsibilities

  • Oversee CRO data management and/or contract data management staff and contributes to the development of clinical data management within the company
  • Ensure projects are conducted in compliance with standard operating procedures, GCP, ICH, Good Clinical data management practices, FDA,EMA and other national regulations, and CDISC and FDA submission standards
  • Review and provide feedback on study documents such as CRFs, data management plans, study protocols, Statistical Analysis Plans, CSRs and other documents as required
  • In conjunction with Quality, lead the development and maintenance of Standard Operating Procedures (SOPs) and Work instructions related to data management activities
  • In conjunction with other functions, assess vendor and technology evaluation, qualification, and selection for CDM and clinical trial applications
  • Work closely with IT and QA to ensure that system infrastructure meet Biometrics needs and industry regulations and best practices.
  • Manage reconciliations between clinical and drug safety databases; timely locking of clinical databases; and completion of
  • data archiving according to GCP, ICH, Good Clinical Data Management practices, and FDA,EMA and other national regulations
  • Ensure data management project documentation is in an audit-ready state
  • Educate clinical team members as needed regarding data management processes, workflow, and data standards that may have direct impact on their work
  • 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

Qualifications

  • Bachelor’s or Master’s degree with minimum of 7+ years of clinical data management experience in pharmaceutical and/ or CRO’s
  • Experienced in successful production of databases for global Phase 3 programs and NDA submissions
  • 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.), ePRO and eDiaries, 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 trial experience desired
  • 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

Fit with Zogenix culture

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with Zogenix’s Core Values of Collaboration, Courage, Compassion and Excellence
  • Excitement about the vision and mission of Zogenix
  • Flexibility
  • Integrity

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