Clinical Data Manager - San Diego, CA | Biospace
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Clinical Data Manager

Therapeutics, Inc.

Location:
San Diego, CA
Posted Date:
8/9/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Data Management, Research,

Job Description

This position is responsible for data management activities, including developing data management plans, supervising database development and reviewing and processing clinical trial data to ensure the completeness, accuracy and consistency of clinical trials databases.

Study Specific Activities
•   Coordinate and complete data management activities to meet project timelines and communicate status to clinical project managers.
•   Develop study specific data management plans and review and approve associated documents: annotated CRFs, database documentation, edit check specifications, data handling conventions and data entry instructions.
•   Work with Clinical Data Associate to ensure that each clinical study database is designed in accordance with the database definitions outlined in the DMP.
•   Review and finalize clinical study database validation plans and lead the database validation team.
•   Complete data verification process and issue data clarification forms (DCFs).  Review completed DCFs and resolve in the database.
•   Prepare electronic data transfer protocols and coordinate data transfers (imports and exports) with third party vendors and consultants.
•   Perform coding for adverse events and concomitant medications and coordinate medical monitor review and approval of medical coding with the clinical project manager.  Reconcile adverse events and serious adverse events.
•   Lead database cleaning and lock activities, coordinating database audits with QA.

General Activities
•   Manage and prioritize data management and data entry activities to meet project schedules.
•   Develop data management resource forecasting and tracking model to assist with project planning and support.
•   Work with biostatistician to compile and maintain TI master SAS data dictionary.  Maintain client specific dictionaries as required.
•   Optimize database development and validation processes to improve departmental efficiency
•   Train and mentor Clinical Data Associate(s) to develop clinical data review and other technical data management skills.


Requirements

The candidate will have a scientific background (BS degree or higher) with 3-5 years of clinical data management experience in the pharmaceutical/biotechnology industry.  The individual must be highly detail-oriented while still maintaining work efficiency, be able to prioritize activities and multi-task across various projects that will be at different study stages. MedDRA and WHO Drug coding proficiency is required.  Previous experience with EDC required.  Experience supporting eCTD submissions through the creation of CDISC/SDTM standard datasets is also highly desired.  Experience using Clindex® clinical data management software is preferred but not required.