Senior Clinical Data Manager

An exciting Oncology focused Pharmaceutical company located in the San Jose area is in search of a contract to hire Senior Clinical Data Manager to join the team!

Responsibilities include:

* Review and provide input from data management perspective on protocols.
* Work in conjunction with Clinical Project Manager on CRF design process utilizing data form standards.
* In collaboration with Clinical, create CRF completion guidelines to be utilized by sites and clinical research associates.
* Work with Database Programmer Analysts to set up, validate and maintain clinical databases in accordance with standards.
* Work with Database Programmer Analysts to develop edit checks.
* Perform user acceptance testing (UAT) of database.
* Manage access to the database by completing access revocation request forms and forwarding them to appropriate database personnel.
* Prepare and present CRF and CRF completion guidelines at investigator meetings.
* Ensure quality data management activities - i.e., data review, query generation and resolution, generate status reports to clinical staff and management.
* Ensure that Data Coordinators complete entry in a timely fashion.
* Create and maintain Data Management Plans, including, but not limited to: CRF/DCF flow, external data handling, SAE processing, coding, lock procedures, and archival procedures, collaborating with Clinical.
* Create and maintain tools for tracking and inventory of CRFs and DCFs.
* Develop guidelines for data entry.
* Generate queries to resolve data issues and apply corrections to database, working with the clinical research associate.
* Perform reconciliation of adverse events with serious adverse events database according to established guidelines.
* Perform coding of medical data using industry standard dictionaries such as MedDRA, WHO Drug, etc.
* Process laboratory data, including laboratory normal reference ranges, from local, central, or external labs according to established guidelines.
* Understand the fundamentals of merging external data with the CRF data.

Qualifications:

* Bachelor's level degree or equivalent in health/science related field.
* The ideal candidate will have 2-5 years of experience in clinical data management; preferably 3 year in device or pharmaceutical clinical trials.
* Strong computer skills including EDC is required.
* Familiarity with clinical trial design and analysis issues.

If this sounds like a good fit for you, apply and I will be in touch with more details on the role.
To find out more about Real please visit www.realstaffing.com