Director, Clinical Data Management

Location: Emeryville, CA
Department: Clinical Development - Fintepla

Summary

The Director of Clinical Data Management is responsible for managing, leading, and overseeing all Clinical Data Management (CDM) planning and operational activities for Zogenix’s MT1621 investigational product to meet corporate goals, budgets, and timelines. This role will be a subject matter expert in the MT1621 trials and methodologies, and responsibilities include oversight of existing vendors, participation in vendor qualification and selection for new vendors, providing input to budget planning and contract negotiations, participation in the development of data management standards, and oversight of end-to-end study activities from protocol development to submission. The Director will develop an in house data management team and processes for MT1621 and oversee the transition away from a fully outsourced model. This position will report to the Senior Director of Data Management.

Responsibilities

  • Oversee CRO data management and contract data management staff and provide hands on support if needed
  • Provide input to and help develop short-term and long-term strategies to improve vendor oversight practices and to bring data management activities in house
  • Work with study team to develop comprehensive data check specifications, queries, and query management processes
  • Provide input to and help develop data management standard Case Report Forms, data cleaning and status reports, and database builds
  • Author or review and provide feedback on study documents such as study protocols Case Report Forms, Data Management Plans, Data Transfer Agreements and Specifications, Study Report Specifications, Statistical Analysis Plans, CSRs
  • Review and provide feedback on SDTM specifications, Pinnacle 21 results, and Study Data Reviewer’s Guides
  • Help develop and maintain Standard Operating Procedures (SOPs) and Work instructions for data management activities
  • Provide input on vendor and technology evaluation, qualification, and selection, and develop detailed scopes of work
  • Specify reconciliation reports and manage reconciliations between clinical and drug safety databases, clinical and external vendor data, and cross-study data
  • Work with the study team to coordinate smooth and timely locking of databases
  • Ensure timely completion of data and document archiving
  • Ensure data management project documentation is in an audit-ready state
  • Mentor and develop team knowledge and skills in their therapeutic area, GCP, CDISC, and industry data management best practices
  • Manage and track vendor progress against work orders to ensure status and spend track to timelines and budgets
  • Cultivate effective and productive working relationships with colleagues, subordinates, and vendors
  • Solve problems and escalate issues with proposed solutions to senior management as needed
  • Other duties as assigned.

Qualifications

  • Bachelor’s or Master’s degree with 10+ years of pharmaceutical data management experience
  • Experience with international and Phase I though Phase III clinical trials
  • In-depth knowledge of FDA regulations, GCP, GCDMP, CDISC, and ICH guidelines
  • Experience working cross functionally and supporting Clinical Operations, Clinical Development, Safety, Statistics, Regulatory, Medical and Quality Assurance functional areas
  • Experience supporting successful regulatory submissions and audits
  • Successful management of and good working relationships with outside vendors
  • Experience mentoring junior staff
  • Ability to work productively in a fast-paced collaborative environment
  • Good organizational, communication and interpersonal skills with the ability to communicate clearly to all organizational levels
  • Experience with a variety of EDC and IRT systems
  • SAS or Tableau programming a plus

Fit with Zogenix culture

  • Ability to build strong relationships with co-workers of various backgrounds and levels of 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 Compassion, Courage, Collaboration and Excellence
  • Excitement about the vision and mission of Zogenix
  • Flexibility
  • Integrity