Description
One of the most sought out Diagnostic companies located in Pleasanton are in search of a Senior Clinical Data Specialist to help lead new clinical trials from study start up to data base lock. This position is contract to hire and will be responsible for the following:* Participate in the evaluation and selection of vendors, e.g. Contract Research Organizations (CROs), EDC software, for outsourced clinical data management activities.
* Coordinate the contract process for selected vendors.
* Develop and manage timelines for key clinical data management deliverables in coordination with the clinical data management CRO.
* Review and approve key clinical data management deliverables, including: Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, serious adverse event reconciliation plans, medical coding and electronic data transfer agreements.
* Monitor vendor performance to ensure that timelines and data quality standards are met.
* Assist with the evaluation, selection, and implementation of new technologies to enhance data management processes.
* Support the implementation of CDISC standards.
* Participate in the development of clinical data management working practices and Standard Operating Procedures (SOPs).
* Ensure compliance of clinical data management processes with applicable regulations and guidelines
Job Requirements:
* Bachelor's degree or equivalent with a minimum of 5-10 years experience in clinical data management across phase 1-3 clinical trials.
* Experience managing vendors and data management activities from project initiation through to database closeout.
* Working knowledge of at least one clinical database system (electronic data capture experience preferred).
* Experience with CDISC CDASH and SDTM standards.
* Able to effectively manage multiple projects and adapt flexibly to changing priorities.
* Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors.
* Clear verbal and written communication skills.
* Strong analytical and problem solving skills.
* Experience working under Good Clinical Practices and other Federal Drug Act guidelines.
*Interviews are underway as this role is very urgent! If you are interested, please apply or call to get things set up.
To find out more about Real please visit www.realstaffing.com