Data Management Associate

Description DATA MANAGEMENT ASSOCIATE

COMPANY INFO:
MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel.

Our client develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions and is seeking to add a Data Management Associate to their team in Novato, CA.

RESPONSIBILITIES:
•    The Data Management Associate’s overall purpose is to manage and execute the data management activities of a clinical trial, from study start up to database lock.  
•    Additional responsibilities include participating in the development of departmental systems and procedures.
•    Responsibilities include supporting the creation of a Data Management Plan and participating in the study team by developing CRFs and edit checks.  
•    Coordinate activities to support entry into the Data Management System, including Electronic Data Capture (EDC) system, to ensure the timely collection and cleaning of clinical data.
•    Independently review clinical data for queries and/or initiate data listings review meetings to identify data discrepancies.  
•    Participate in medical coding of adverse events and medications.  Manage vendor relationship to ensure complete, accurate, and timely transfers of clinical data.   
•    Coordinate the transfer of lab results, ECG findings and other electronic data created outside of the case report form.  
•    Integrate CRF and non-CRF data and execute the database lock procedures and ensure study timelines are met.
•    The position progressively supports development of the data management function in alignment with the requirements of the department and organizational goals.  
•    In addition, the position is responsible for the performance of Contract Research Organizations (CRO’s), and developing methods and standards that will enable the company to grow its internal capabilities.  
•    Internally resourcing these activities will enable Company to improve efficiencies across studies and reduce expenses.

Requirements •    Minimum educational experience is a Bachelor of Science degree or equivalent experience.  
•    Minimum years of experience are three years of progressive Clinical Data Management experience in the pharmaceutical or biotechnology industries.
•     Experience creating forms and writing data validation specifications.  
•    Self-directed learner with strong communications and adaptive skills along with a high level of interpersonal collaborative/team skills to influence and build strong internal and external relationships.  
•    Knowledge of ICH and FDA (21 CFR Part 11) guidelines, as well as CDISC Submission Data Tabulation Model standards.
•    Preferred experience includes basic programming experience using SAS statistical software.  Addition technical expertise with EDC applications is a plus, particularly MediData Rave. Some experience coding medical terminology in MedDRA and medicines in WHO Drug desirable.

MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.