Job Description

 A highly reputable medical device corporation is currently hiring for a Clinical Data Management Associate - Level II to work in San Diego, CA.

SUMMARY:

• Collaborates with various departments on the design, documentation, testing and implementation of clinical data studies. Develops systems for organizing data to analyze, identify and report trends.
• Analyzes the interrelationships of data and defines logical aspects of data sets.
• Prepares reports of clinical trial studies for internal validation and cross validation studies.
• May evaluate and resolve issues regarding contents of reports.

SUMMARY:

• Responsible for all data management functions related to clinical conducted under Internal Clinical Study program.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Designs subject case report forms for receiving, processing and tracking data
• Develop study specific annotated CRFs, database documentation, edit check specifications, data handling conventions and data entry instructions
• Designs and validates clinical databases including designing or testing logic checks.
• Processes clinical data including receipt, entry, verification and filing of information
• Generates data queries based on validation checks or errors or omissions identified during data entry to resolve identified problems.
• Performs quality control audits to ensure accuracy, completeness, and proper use of clinical data system
• Responsible for filing and maintaining CRFs, subject diaries, and other subject-specific documentation (e.g., Marketing questionnaires) collected during clinical studies.
• Responsible for filing and maintaining digital data (e.g., Receiver downloads, and blood glucose meter downloads) collected during clinical studies.
• Summarizes basic elements for clinical databases periodically.
• Communicates with end users to define or implement clinical data management requirement for the clinical study such as data release, delivery schedules, and testing protocols.
• Writes sections of clinical study reports with assistance.
• Provides training and technical support to clinical site personnel on EDC for specific studies.
• Maintains more than 3 study databases and data management activities concurrently.
• Ability to multi-task while still being detail oriented
• Works with management or senior Clinical Data Management Associates to develop project-specific data management plans that address areas such as data reporting, transfer, database lock and work flow.
• Works with management or senior Clinical Data Management Associates to write work instruction manuals, data capture guidelines, or standard operating procedures.
• Monitors work quality to ensure compliance with standard operating procedures.
• This position assumes and performs other duties as assigned.

EXPERIENCE/EDUCATION:

• Requires a Bachelor’s degree in a technical discipline
• Minimum of 2+ years related experience in clinical data management
• Excellent interpersonal, verbal and written communication skills.

Company Description

Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.