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H - Regulatory Affairs Specialist 3 RECRUITED - 18M027 - 100611
Ref No.: 14-02555
Location: Tarrytown, New York

Short Description:
Provide clinical data management support for investigational device studies.

Complete Description:
Position is responsible for clinical data management of investigational device studies. Candidate should have 3-5 years work experience in an R&D
or clinical environment with 2+ years in the following areas:

Major Tasks:
- Ensures proper collection, clarification and management of clinical trials data. Ensures data are collected according to regulatory requirements.
- Develops clinical trial data management plans including data entry guidelines, edit specifications, data acquisition and processing procedures.
- Prepares Case Report Forms to ensure data will support the clinical study objectives.
- Downloads or enters data from investigational sites and checks data for protocol compliance.
- Works with clinical research associates and investigators to resolve data quality or noncompliance issues.
- Validates software and databases used for clinical trials.
- Audits and locks clinical trials datasets.
- Generates reports that summarize and present data.

- CRF design
- CRF validation
- Data Cleansing
- Excel and Excel macros (VBA)
- Writing a Data Management Plan
- Perfoming a data audit
- Knowledge of regulations relating to clinical data management
- knowledge of a Electronic Data Capture Systems.

Experience with Structured Query Language (SQL) is a plus.

Behavior Characteristics:
Team oriented
Detail oriented
Ability to work on teams when members are located in multiple locations