Clinical Systems Administrator

Job type:
Start date:
Real Staffing
South San Francisco
Published at:
flag_no USA
Project ID:

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Clinical Systems Administrator

A large pharmaceutical company in the South San Francisco Bay Area is urgently looking for a Clinical Systems Adminstrator to join their team. They are looking for someone with extensive knowledge in Clinical Data Management. This is an exciting opportunity to join a large company with ane excellent pipeline.

Clinical Systems Administrator Duties

Manage the lifecycle of Rave and other data management systems (e.g., Safety Gateway, Lab Admin, etc) in accordance with our project management methodology which includes development of scope, gathering business requirements and functional specifications, implementation, testing, deployment and ongoing maintenance.
Support the Data Management team in all Rave related functions including troubleshooting issues and liaising with IT and Medidata representatives to facilitate issue tracking and resolution.
Perform Rave administrator activities by maintaining codelist, database libraries and user roles and responsibilities.
Ensure timely updates of MedDRA and WHO-DD coding dictionaries
Maintain global libraries and lab standards used for clinical study builds
Support routine and ad hoc data extractions
Manage the registration, testing and maintenance of all integration processes with external parties (i.e., E2B reporting, central labs, medical coding)

SkillsFunctional/Technical Knowledge

Knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing clinical data management environments
Experience as subject matter expert with software-based data management systems required, direct experience with Rave highly desired
Ability to interpret clinical protocol data collection needs and implement in an electronic data collection (EDC) system.
Expertise in laboratory tests, ranges, and conversions
Expertise in MedDRA and WHODrug coding dictionary maintenance and use
Experience in creating computer system validation deliverables such as specifications, protocols, and reports as well as experience in executing protocols and test scripts.
Expert computer skills (MS Office)

If interested in this excellent opportunity please respond to this post as soon as possible. This client wants to get people in for interviews as soon as possible.

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