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University of Rochester Clinical Trials Data Manager - 232794 in Rochester, New York

Clinical Trials Data Manager Job ID 232794

Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening

Full Time 40 hours Grade 053 Path&Lab Clinical Trials

Responsibilities

POSITION SUMMARY:

Under general direction from the Manager, Data Management, and with considerable latitude for independent judgment, develops data management plans and custom query programming to format data to meet client requirements. Validates system data extracts and reports; participates in system development and validation activities. Performs test and report set up activities as needed to support the Clinical Trials Information Systems team.

SUPERVISION AND DIRECTION RECEIVED:

Reports directly to the Manager for Clinical Trials System Support. Works closely with project management staff, business development, and finance to create and produce reports from the ClinAxys II system database.

SUPERVISION AND DIRECTION EXCERCISED:

Provide direction to Clinical Trials support staff for data cleaning required to ensure a consistent database for each project.

MACHINES AND EQUIPMENT USED:

Standard office equipment such as multi-feature ACD telephone, PC, copier, printer, fax machine, and the like. Software systems such as Laboratory Information Management Systems (LIMS), Laboratory Information Systems (LIS), databases such as MS Access, project management tools such as MS Project, statistical analysis software and various document design software applications. May also be required to utilize customer and vendor provided applications and portals.

JOB RESPONSIBILITIES:

  1. Provide data transfers and reports per client specifications (30%)
  • Communicate with internal and external customers to obtain data or information reporting requirements to provide data-based solutions to business needs.

  • Create Data Transfer Agreements with external customers to record data and service requirements.

  • Provide properly formatted data output or reports to customers on a timely basis.

  • Set up and maintain secure data transfer mechanisms, such as sFTP sites or portals.

    1. Develop programs and queries to manage data from clinical trials and research studies (25%).
  • Develop queries, programs, and reports to extract and format data from Relational and Hierarchical Databases.

  • Develop data flow diagrams and data dictionaries to document data origins, transformations, and outputs.

  • Perform complex data manipulation using multiple data sources.

    1. Evaluate and ensure data quality (20%)
  • Review, analyze, and validate data to ensure consistency, integrity and accuracy based on project specific guidelines.

  • Execute data quality checks and query data inconsistencies in compliance with standard operating procedures, client guidelines and regulatory agency guidelines.

  • Develop and implement strategies for data cleaning.

  • Assist in the design and programming of clinical databases.

    1. Assist in the management of clinical trials information systems (15%)
  • Assist the Manager for Clinical Trials System Support in test set up, user security, and user training activities.

  • Troubleshoot system problems for users.

    1. Prepare necessary materials and documentation for projects (5%)
  • Develop Standard Operating Procedures for managing data.

  • Complete risk assessments in support of validation plans.

  • Maintain System documentation in an audit-ready state.

    1. Other duties and projects as assigned (5%)

    FUNCTIONAL REQUIREMENTS:

  • Ability to maintain a friendly and courteous professional manner at all times.

  • Ability to interact effectively and professionally with co-workers, customers, and vendors.

  • Excellent computer and organizational skills; programming skills including SQL and commercial reporting and data mining tools.

  • Strong technical communication and documentation skills.

  • Ability to adjust work schedule if needed to meet project timelines.

    GENERAL REQUIREMENTS:

  • Adheres to all departmental and organizational policies and procedures.

  • Demonstrates all aspects of Strong Commitment

    QUALIFICATIONS:

Bachelor's degree in related discipline such as Computer Science, Business, Mathematics, Statistics, Science or Engineering, with 2-3 years of experience in clinical or medical data management or an equivalent combination of education and experience. Experience with MS Access, SQL Server or MySQL, Oracle, SAS, and Crystal Reports desired. Medical Laboratory terminology preferred.

Ability to maintain a friendly and courteous professional manner at all times. Ability to interact effectively and professionally with co-workers, customers, and vendors. Excellent computer and organizational skills; programming skills including SQL and commercial reporting and data mining tools. Strong technical communication and documentation kills. Ability to adjust work schedule if needed to meet project timelines.

How To Apply

All applicants must apply online.

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