Senior Clinical Data Manager

Clinical Data Manager, OrangeCounty, Contract or Permanent

My Pharmaceutical client based in Orange County is looking for a Clinical Data Manager on either a contract or permanent basis.

Job description
Responsible for the role which includes the execution of the data review strategy for one or more studies as defined by the individual study Data Management Plan. Initiation and management of the data clarification process, coordinating with other stakeholders to ensure appropriate resolution to all data clarifications prior to database lock.

Requirements
Degree or equivalent experience in Clinical Research, Computer Science, Project
Management or related field: 6 years experience, or BS/BA degree with 4 years
experience, or MS degree with 2 years experience.
- Minimum 2 years experience within a clinical data management organization,

preferably within medium-large pharma or CRO.
- Intermediate knowledge and understanding of regulatory guidelines for the use of computer

systems in clinical trials
- Intermediate knowledge of Research & Development and an understanding of regulatory

guidelines/requirements related to R & D (e.g., ICH, GCP, safety reporting)
- Intermediate knowledge of global standards related to clinical study data management activities

(CRF design, data standards, database design, coding and coding dictionaries, etc.)

This is a fantastic opportunity for a long term contract or permanent position with a top end client.

Please apply immediately to be considered for an interview

Key Words: Clinical Data Management, Regulatory, EDC, CRA, Clinical Coordinator,

To find out more about Real Staffing please visit www.realstaffing.com