Lead Clinical Data Manager - NC in Raleigh, NC at Apex Life Sciences

Date Posted: 8/13/2018

Job Snapshot

  • Employee Type:
  • Location:
    Raleigh, NC
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

Title: Sr. Clinical Data Manager

Location: Raleigh, NC
Type: Direct Hire

In this position, you will, in collaboration with a European & USA based DM team, be in charge of all aspects of the data management process. Being based in the US, you will be the lead data management contact for some of the Clients US-based clients. You will be in charge of complex projects requiring a long-term experience and high level competencies in clinical data management.
• Communication with the sponsor and other collaborators of the project regarding data management issues.
• Production and Maintenance of key study related documentation (Data Management Plan, Data Validation Plan, EDC specifications, Data Management Report) according to standard operating procedures.
• CRF design and review determining the data collection requirements of the study through review of the protocol and other supporting documentation.
• Creation of the edit-checks included the Data Validation Plan as well as the listings and reports as agreed with the sponsor.
• Coordination of all data cleaning activities including DCF/query handling and coding management.
• Coordination of external data transfer, integration and reconciliation with the study database.
• Coordination and finalization of database lock activities in close collaboration with the sponsor, statistician and other parties.
• Development of standardization (templates and processes).
• Coaching of more junior staff
• University degree, preferably in science
• Thorough knowledge of the Data Management process
• Minimum 5 years of successful Clinical Data Management experience
• Experience in EDC systems set-up is required
• SAS programming knowledge and experience is useful
• CDISC standards knowledge is beneficial for the position
• Excellent organizational and communication skills  

To apply to this position please contact:

Vickie Dagit, Recruiter




EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.