Title

Senior Clinical Data Manager 


Req Number BIO-12-00001  

Location Optimer Pharmaceutical - San Diego  

Position Senior Clinical Data Manager  

Exempt/Non-Exempt Exempt  

Full-Time/Part-Time Full-Time  

Description

Position Summary

The Senior Clinical Data Manager (CDM) will provide Data Management support to ensure a high quality clinical trial database compliant with Optimer data quality standards.

Responsibilities include:

  • Review the study protocols to ensure the data collection requirements are clearly specified support the study endpoints.
  • Develop the Data Management Plan (DMP) and the Data Validation Plan (DVP).
  • Design and develop the eCRF (electronic CRF) working with cross-functional teams. 
  • Develop the eCRF Completion Instructions to aid site personnel to enter clinical trial data.   
  • Develop Edit Check specifications.
  • Perform User Acceptance Testing of the eCRFs to ensure the integrity of the clinical trial data.
  • Conduct data review, query generation and resolution.
  • Interface with study site personnel to expedite the data resolution process.
  • Conduct medical coding of all textual data including AEs and Concomitant medications.
  • Develop data management SOPs and Work Instructions.
  • Train CRAs and site personnel in the use of the Electronic Data Capture (EDC) system.
  • Prepare data transfer specifications for vendors including laboratory data, ECG data or other data sources.
  • Review external data transfers from vendors and raise and resolve data quality issues
  • Maintain knowledge of current regulations and technologies related to the data management function.
  • Knowledge of clinical research processes and FDA, EMEA and ICH Data Management guidelines.
 

Position Requirements

Education / Experience / Skills Requirements

  • A Bachelor's Degree or higher in life sciences or statistics or computer science.
  • Minimum 5 years of Clinical Data Management experience in clinical development.
  • CCDM certification strongly desirable.
  • Experience working with EDC systems.
  • Experience in designing and developing the eCRF
  • Proficiency with coding processes using MedDRA and WHO-DRUG dictionaries.
  • Knowledge and experience with CDISC and SDTM.
  • Proficiency with Microsoft Office software suite.
  • Effective verbal, written and presentation skills
  • Strong Project Tracking skills.
  • Good interpersonal skills.

 

This job description is intended to describe the general nature and level of work being performed.  This description is not intended to list all of duties and responsibilities, but to provide a summary.   An employee holding this position will be required to perform other duties as needed. 

 

Recruiter Disclaimer - Optimer's Talent Acquisition team appreciates recruiter interest, however, unsolicited resumes or calls from third parties will not be accepted at this time. Optimer does not accept unsolicited resumes from outside recruiting firms. Any resume submitted in the absence of a signed agreemen will become the property of Optimer and no fee shall be due.  

Close Date  

Number of Openings 1  

Open Date 2/8/2012  


This position is currently accepting applications.


 


AppOne.comTM   copyrightŠ1999-2013 HR Services, Inc.
Click here for technical assistance.