Senior/Director, Clinical Data Management (San Diego Based)

Location
San Diego, CA
Salary
Base plus Bonus plus Options!
Posted
May 14, 2018
Required Education
Bachelors Degree
Position Type
Full time

Opportunity

This an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas. 

The Director (Sr) of Clinical Data Management is responsible for leading the Data Management (DM) function within the Clinical Development Department, ensuring operational strategy and implementation are compliant and integrated, and provides direct leadership of all DM activities. In partnership with the VP of Biostatistics and DM, the director will participate in the establishment and harmonization of program management’s processes, standards, tools and best practices.

What you’ll dive into

  • Overall accountability for the strategy and leadership for all trial-related DM activities, including, but not limited to:
    • Outsourced CRO DM selection and management
    • Database platform selection, design, build out and User Acceptance Testing
    • Cross functional alignment on CRF/eCRF design per protocols and objectives
    • Clinical trial DM Plan
    • Database development and validation programming
    • Establish plan for data quality control, including consistency and accuracy of data collection, edit checks, data query management, and quality audits
    • Establish and direct ongoing cross-functional data review plan
    • Manage data cleaning and preparation for database freeze/locks during conduct and at trial completion
  • Develop, manage and lead the internal and external DM team and resources, focusing on an outsourced data management model
  • Ensure comprehensive data review and timely execution of accurate “clean” clinical database lock
  • Provide DM procedure training to Arena and study site personnel
  • Assist the Clinical Development Department with the medical and data quality review of clinical data by programming data visualization tools (i.e., J-Review, Spotfire) or generating patient profiles, tables, figures and listings

What we expect

  • Bachelor’s in relevant field; Advanced degree preferred
  • 12+ years of progressive and relevant experience in pharmaceutical or biotechnology clinical trial data processing and management
  • 5+ years of direct/indirect management experience required
  • Significant and demonstrated experience selecting/managing DM CROs and vendors
  • Significant experience with Medidata Rave and/or Oracle InForm EDC systems
  • Strong technical skills and knowledge of DM database system and relevant computer languages (i.e., SQL, SAS).
  • Demonstrated ability to lead, mentor and manage others
  • Motivated to work in a fast-paced, high accountability environment
  • Significant experience using MS Office including Project, Excel, PowerPoint required; Experience with SharePoint preferred
  • Potential for travel (US and International)

What you’ll get

  • To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
  • Opportunities to learn and contribute creative solutions
  • Comprehensive health insurance ($0 premium on select medical plans)
  • Matching 401k retirement plan
  • Paid time off and holidays including a Summer & Winter break
  • Company celebrations

Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at jobs@arenapharm.com.