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Clinical Data Manager

Ironwood Pharmaceuticals, Inc.

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Location: Cambridge, MA Posted Date: 4/18/2013 Position Type: Full time Job Code: biospaceposting Required Education: Bachelors Degree Areas of Expertise Desired: Clinical Data Management

Description

Clinical Data Manager II

Position Description:

Provide timely and professional ongoing oversight of clinical trial data Phases I to IV. Represent Data Management in internal team meetings. Identify requirements for capture and processing of clinical data ensuring accuracy, consistency and completeness.  Oversee external vendors providing clinical data.  Prepare material for and present at Investigator Meetings as needed. Perform Data Management tasks so that databases can be declared clean and locked according to strict quality standards including SAE reconciliation, third party vendor data reconciliation, medical coding processing, protocol deviation collection, query management to identify errors and inconsistencies in clinical data and ensure their resolution.
This position will have a heavy emphasis on internal UAT process improvement and documentation practices.

Responsibilities:
•   Coordinates and manages data management tasks for Phase I-IV clinical studies.  
•   Acts as primary liaison with CROs, third party data vendors, EDC vendors (EDC experience is a must).
•   Develops or is primary reviewer of Data Management Plans including Edit Check Specifications, Database Specifications, Coding Guidelines, Data QC processes, etc.  
•   Ensures that Data Management Plans are followed throughout the course of the studies.  
•   Primary reviewer or author of eCRFs, form completion guidelines.
•   Performs UAT testing.
•   Performs ongoing review, data cleaning, query generation and resolution.
•   Ensures Data Management project timelines are met.  
•   Provides comprehensive status updates to biometrics and project team members.

Requirements

Position Requirements:
*  Bachelors or Masters Degree in a health-related field.
*  Three to six years of clinical data management experience in a regulatory environment within the pharmaceutical, biotechnology or CRO industries.  
*  Demonstrated proficiency initiating and managing clinical data projects.
*  Knowledge of, and experience with EDC databases, CDISC standards, medical terminology, medical coding dictionaries, quality control processes and auditing procedures.
*  Familiarity with GCP, ICH and FDA requirements as they apply to Clinical Data Management.
*  Regular interaction with Clinical Operations, Biostatistics, Project Management and Quality Assurance groups.
*  Must be able to manage multiple initiatives and shifting priorities within a small company environment.
*  Excellent written and oral communication skills required.
*  Occasional travel.
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