Clinical Data Manager (San Diego Based)

Location
San Diego, CA
Salary
Base plus Bonus plus Options!
Posted
May 11, 2018
Required Education
Bachelors Degree
Position Type
Full time

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 Clinical Data Manager (CDM) is responsible for leading data management activities, including CRO oversite for multiple clinical studies within a clinical development program. The CDM participates in the design and oversite of the database, to include database build and User Acceptance Testing.

What you’ll dive into

  • Serves as the clinical data manager for all data management (DM) activities for clinical studies
  • Plans, manages and performs data processing and management activities for assigned studies
  • Oversees and collaborates with CRO’s Database Management function regarding all DM activities for clinical studies
  • Authors or leads the development of the Data Management Plan (DMP)
  • Designs or leads the design and review of case report forms (CRFs/eCRFs) and completion guidelines
  • Designs or leads the design of clinical database using the Company’s standards and/or the CRO’s specifications, including the review of database design and function specifications to participate in User Acceptance Testing (UAT)
  • Defines, validates, reviews and documents database edit checks
  • Writes queries on missing data and data points failing pre-defined range checks and/or logical checks; Leads efforts in developing and maintaining standard database integrity checks for common modules as well as for therapeutic/drug area specific modules
  • Ensures accurate and timely medical coding of medical history, adverse events, concomitant medical products
  • Assists the Company, CROs and investigative sites with issuing and resolving data queries
  • Ensures comprehensive data review and timely execution of accurate “clean” clinical database lock
  • Manages final archival of data management documentation, and assists Clinical Trial Team in assembling and archiving the documentation
  • Assists the Clinical Development Department with the medical and data quality review of clinical data by programming data visualization tools (i.e., J-Review, Spotfire) and/or generating patient profiles, tables, figures and listings

What we expect

  • Bachelor’s in relevant field; Advanced degree preferred
  • 5+ years of progressive and relevant experience in pharmaceutical or biotechnology clinical trial data processing and management
  • Demonstrated experience managing clinical trial data management activities, applying data management concepts, clinical trial data processing techniques, and integrating them with the entire clinical trial operations
  • Demonstrated experience with CRO and vendor management
  • Significant experience with Medidata Rave and/or Oracle InForm EDC systems
  • Motivated to work in a fast-paced, high accountability environment
  • Significant experience using MS Office including Project, Excel, PowerPoint required; Experience with SharePoint or similar, highly 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.