Senior Clinical Data Manager in San Diego, CA

$150K - $200K(Ladders Estimates)

Arena Pharmaceuticals, Inc   •  

San Diego, CA 92101

Industry: Pharmaceuticals & Biotech


11 - 15 years

Posted 64 days ago

This job is no longer available.

The opportunity

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

The Senior Clinical Data Manager (Sr. CDM) is responsible for leading data management activities, including Contract Research Organization (CRO) oversite for multiple clinical studies within a clinical development program. The Sr. CDM participates in the design and oversight of the database, to include database build and User Acceptance Testing. In addition, the Sr. CDM creates and provides reports on the progress and status of the on-going study data management activities and deliverables, ensuring assigned projects are delivered on track with high quality and accuracy.

What you'll dive into

  • Serves as the Lead Clinical Data Manager for all data management (DM) activities for clinical studies
  • Plans, manages and performs data processing and management activities for assigned studies based on compliance with study specifications and the Company's requirements/established timelines
  • Oversees and collaborates with CRO's Database Management function regarding all DM activities for clinical studies
  • Reviews clinical study protocols, statistical analysis plans (SAP), and clinical study reports (CSR)
  • Leads the development of the Data Management Plan (DMP)
  • Leads the development of the study Data Validation Manual (DVM) as required
  • Leads the design and review of case report forms (CRFs/eCRFs) and completion guidelines
  • Leads the design of an efficient 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 to ensure electronically captured data are accurate and efficiently retrieved
  • Writes clear 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
  • Coordinates CRF/Data Clarification Form (DCF) tracking as needed
  • Ensures medical coding (e.g., MedDRA, WHO Drug) is performed in an accurate and timely manner, as directed by the DMP
  • Ensures accurate and timely resolutions of medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products
  • Defines and monitors clinical trial data flow and quality control processes in accordance with Company Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and Good Data Management Practices (GDMP)
  • Assists the Company, CROs and investigative sites with issuing and resolving data queries
  • Ensures comprehensive data review and accurate ("clean") locked clinical database
  • Ensures timely execution of database lock per study and company timelines
  • Maintains and prepares final archival of data management documentation relevant to the assigned clinical studies, and assists the Clinical Trial Team in assembling and archiving the documentation
  • Prepares and presents DM topics to the Clinical Trial Team or Product Development Team
  • Provides operational and technical guidance and direction regarding DM activities
  • Provides training to new Company and study site personnel on data management processes and procedures, data entry and review with electronic data capture systems, data flow and quality control processes
  • 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
  • Assists the Quality Assurance Department with quality control audits on assigned databases
  • Validates and disseminates real-time study monitoring reports to Clinical Trial Team and Product Development Team
  • Other duties as assigned or required

What we look for

  • BA/BS in health and/or pharmaceutical sciences, computer and/or mathematical sciences, or relevant scientific disciplines; Advanced degree preferred\
  • 10+ years of progressive and relevant experience in pharmaceutical or biotechnology clinical trial data processing and management
  • Significant 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
  • Working knowledge of the clinical drug development process, FDA regulatory requirements, ICH/GCP guidelines, CDISC standards, and industry standard practices regarding DM
  • Demonstrated ability to act/think strategically and see "the big picture", all the while being hands on
  • Demonstrated ability to handle high volumes of work in a fluid, dynamic, stressful and fast-paced environment
  • Demonstrated ability to work simultaneously on multiple projects, and to deliver high-quality work according to tight timelines
  • Demonstrates excellent communication (verbal/written/presentation) skills
  • Demonstrates sound judgment, facilitation and interpersonal skills
  • Detail-oriented with effective problem-solving and troubleshooting skills
  • Process oriented with the ability to understand complex data and information
  • Significant experience and understanding of medical terminology
  • Significant experience using Microsoft Office Suite including Project, Excel, PowerPoint required; Experience with SharePoint or similar work management software/systems highly preferred
  • Passion for science
  • 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
  • Company celebrations.

Valid Through: 2019-9-12