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Sr. Data Manager

Req #: 1700690
Location: San Diego, San Diego US
Job Category: Clinical Operations
Work Location: 3033 Science Park Road Suite 300 RCPTSD 92121
Organization: Receptos, Inc.
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- CA- San Diego- Science Park

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Responsible for partnering with the cross functional study teams as well as CROs to ensure delivery of high-quality clinical trials data for analysis.  This individual will provide oversight and ensure a focus on timely and quality delivery and consistency across all Data Management components within a particular development program. The Senior Manager, CDM participates in the development of protocols, statistical analysis plans, clinical data management plans, and other study related documentation.  Oversees the work of CROs that are performing any Data Management tasks.  May travel up to 10%.

  • Provide oversight and project management support of all CDM deliverables within a study/program
  • Project level coordination and day to day oversight of CDM tasks including:
    • Coordination of lead DM’s within the project
    • Review and oversight of all DM documents within a project area to ensure a consistent approach
    • Overview of project timelines and metrics to ensure databases are delivered to set timelines
    • Approval of database locks
    • Ensuring that quality control checks are occurring such that quality databases are delivered
  • Ensure quality & relevance of data listings from the data management systems to support cross functional and medical monitor review
  • Ensure a foundation of partnership to build a long-term relationship with CRO partners / external vendors
  • Support the Director, CDM in the oversight of CROs for outsourced studies
  • Attend team meetings as needed to represent CDM interests
  • Assist in the development, maintenance and monitoring of CDM policies, standards, and practices
  • Review protocols and SAPs and provide input relevant to data management issues
  • Provide input for the development of project specific timelines
  • Ensures proper archival of all CDM documents at Receptos
  • Ensure a constant state of inspection readiness & compliance
  • Ensure study specific data transfer specifications in support of clinical data transfers are in place
  • Monitor and communicate major shifts to project timeline to project stakeholders
  • Other responsibilities as assigned.

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Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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