Clinical Data Manager

Interview : Phone and skype

Visa : All apart from the one's that have employer name mentioned on the visa copy

#1 critical need is to be aneffective communicatorto peers & stakeholders
# 2 critical need is to bedynamic(having a well-round and diverse background is helpful)
At least 3 years of clinical data management experiencein Medical Device/CRO/Biotechnology (and/or Pharmaceutical) company
Ideally being an activeparticipation in cross-functional teams

Description :
The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Client, is recruiting for a Clinical Data Manager, to be in Irvine, CA or remotely within United States.

The Clinical Data Manager is a key player in a cross functional team leading all aspects of study execution. S/he ensures clinical trial data collected meet the highest standards of data integrity, while maintaining metrics, meeting timelines and adhering to study budgets.

Key Responsibilities:

• Independently lead 1-2 clinical research trials in a variety of study phases
  • (e.g. First in Man, Investigational Device Exemption, post market surveillance)
• Experience with the development of high-quality database solutions
• Working knowledge of data modelling programming languages such as SQL, SAS or R etc.
• Review and validation of clinical database, including management of CRO activities
• Responsible for all aspects of data management associated with data cleaning andquality review processes
• Maintain all study level documentation including data management plans, specification documents and evidence of completed review processes
• Coordinate, facilitate and manage all data management activities
  • From initiation of protocol through database lock
• Accountable for errors and data discrepancies for the life of a project
• Independently contribute towards process improvement and data standards
• Know and follow all laws and policies that apply to the job, and maintain the highest levels of integrity, ethics and compliance at all times

Qualifications:

• Must be a self-starter and very independent
• #1 critical need is to be aneffective communicatorto peers & stakeholders
• # 2 critical need is to bedynamic(having a well-round and diverse background is helpful)
• At least 3 years of clinical data management experiencein Medical Device/CRO/Biotechnology (and/or Pharmaceutical) company
• Ideally being an activeparticipation in cross-functional teams(highly desired)
• Project Management skills are essential for this position
• Excellent written, oral and presentation skills

Education:

• A Bachelor's degree (or equivalent) in Computer Science or related discipline
• Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software required
• Experience withElectronic Data Capture (EDC)required
  • Medidata (highly desired)
• Knowledge of medical terminology
• Experience with the development of high-quality database solutions
• Working knowledge of data modelling programminglanguages such as:
  • SQL
  • SAS
  • R
• Knowledge of reporting or data analysistools:
  • Business Objects
  • J-Review