Senior Data Manager
Location:
Diamond Bar , California
Posted:
December 20, 2016
Reference:
1562160727-en-us

Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Senior Data Manager for Biosense Webster located in Diamonda Bar, CA. and/or Irvine, CA.  


The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, Sedation and Reprocessing all headquartered in our talent hub in Irvine, CA.


Biosense Webster is the global leader in the science of diagnosing and treating heart rhythm disorders and one of the fastest-growing businesses within Johnson & Johnson. Learn more at Biosense Webster at <a href="www.biosensewebster.com">www.biosensewebster.com</a>

 

The Senior Data Manager will be responsible for all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects with minimal supervision. S/he ensures clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets.

 

Reporting to the Manager, data management / Lead Data Manager this individual will;

 

  • Support CRF design, review and validation of clinical database, including supporting management of CRO activities in this area
  • Have the ability to support a number of moderate complexity / complex trials with minimal supervision
  • Be responsible for creation of data management plans and other data management documentation as needed with minimal oversight
  • Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to  ensure all remain on target to project timelines
  • Be responsible for coordinating, facilitating and participating in all data management activities from initiation of protocol through database lock with minimal oversight, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their respective projects
  • Be responsible for participating in ongoing data review throughout the conduct of the study, including being responsible for the correction of errors and discrepancies management for the life of a project
  • Proactively identify and address issues that may impact the quality of the data, deliverables or timelines
  • Be responsible for handling of non-CRF data, including lab data and image handling
  • Be responsible for co-ordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed
  • Contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with data management leadership as needed
  • Be responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner
  • Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times
  • Diligently participate in compliance program-related activities as denoted by the supervisor or our Chief Compliance Officer
  • Performs other related duties as required

 

:

 

  • Therapeutic area knowledge in at least one of orthopedics, gynecology, cardiovascular, or general surgery
  • Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc
  • Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software
  • Experience with Electronic Data Capture (EDC), Medidata RAVE preferred. Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug)

Qualifications
  • A Bachelor’s degree in the Biological Sciences, Computer Science or related discipline, with at least 4 years of  clinical data management experience in Medical Device or Pharmaceuticals
  • Experience of supporting trials with minimal supervision

 

This position is located in Diamond Bar, CA. and may require up to 15% travel, domestic and/or international.  In 2017, this position will be relocating to Irvine, CA. 

 

BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

 

Johnson & Johnson Companies are equal opportunity employers.

 

We are driving a world of industry-leading innovation taking place right here in California, every day. In a state known for cutting-edge technology, discover a group of companies known for transforming the future of health care. Watch our talented employees passionately speak to the broad range of opportunities for personal fulfillment, career flexibility and professional growth that inspire them to feed their passion here http://youtu.be/hUO6xtsudoA


Primary Location
United States-California-Diamond Bar
Organization
Biosense Webster Inc. (6010)
Job Function
Clinical Data Management

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