BostonRecruiter Since 2001
the smart solution for Boston jobs

Data Quality Analyst

Company: Global Technical Talent
Location: Boston
Posted on: November 23, 2021

Job Description:

Data Quality AnalystPosition Summary:

The Office of Data Quality (ODQ) provides research support to the Cancer Center with a focus on quality assurance, quality control, and process improvement. Functions of ODQ include protocol subject registration and randomization, clinical research auditing, data, and safety monitoring, quality control of DF/HCC initiated clinical trial data, national protocol and investigator registrations, DF/HCC multi-center coordination oversight, participation in general clinical trials education, and committee management. The Data Quality Manager supervises all Data Quality Analysts. The Data Quality Manager reports to the Director of ODQ. The Data Quality Analysts work closely with investigators, research teams, and biostatisticians to ensure the integrity and quality of clinical trial data. Data Quality Analysts monitor the timely submission and completeness of clinical trial data entry, perform edit checks on the data, issue and resolve data queries, and perform other quality control and data cleanup tasks. Minimum Job Qualifications:Data Quality Analyst I:
Bachelor of Science or Bachelor of Arts with scientific specialty or other relevant major. Prior experience working in a medical or scientific research setting or comparable data-oriented role is required. Greater than 1 year of relevant experience is preferred. Experience with electronic data capture systems and electronic case report forms (InForm preferred). Ability to communicate clearly and effectively with written and verbal English. Data Quality Analyst II:
Bachelor of Science/Arts required with at least 2 years of relevant work/research experience. Familiarity with regulatory requirements and best practices related to the conduct of human subject research (e.g., FDA regulations, ICH GCP). Experience with electronic data capture systems and electronic case report forms (InForm preferred). Knowledge and/or experience in data management or quality control is a plus. Ability to communicate clearly and effectively with written and verbal English. Senior Data Quality Analyst III:
Bachelor of Science/Arts required. Master---s degree (MPH, Biostatistics, Social Sciences, or other relevant fields) preferred. At least 3 years of relevant experience in clinical research, quality control, and/or data management. A strong understanding of regulatory requirements and best practices related to the conduct of human subject research (e.g., FDA regulations, ICH GCP) is required. Experience with electronic data capture systems and electronic case report forms (InForm preferred). Exceptional knowledge and/or experience in research methods, database design, and programming are preferred. Excellent English language reading, writing, and speaking skills are required. Job Requirements:Primary Duties and Responsibilities:
Ensures clinical trial data collected throughout the conduct of a protocol are complete and accurate. Using InForm EDC reviews data captured on electronic case report forms to verify completion per protocol requirements. Reviews program-generated queries and responses, reissues queries as appropriate, and closes queries upon resolution. Generates query reports for distribution to study teams. Performs logical edit checks on the data and reviews trends in the data to identify potential errors. Manually issues queries in response. Performs other related quality control tasks to identify discrepancies and violations. Reports findings to investigators or ODQ leadership as appropriate. Manages the collection and entry of clinical trial data on paper case report forms. Collects completed case report forms from research teams. Performs quality control activities on the collected data, requests clarifications as appropriate. Enters data from paper case report forms into electronic systems. Monitors completeness and timeliness of clinical trial data entry. Generates monthly/quarterly missing data reports for distribution to research teams. Reviews missing data reports for significant non-compliance and notify investigators or ODQ leadership as appropriate. Generates data reports for review by DF/HCC oversight committees (e.g., DSMB, DSMC) Acts as a resource for investigators and study teams for items related to clinical trial data Communicates directly with investigators and research teams regarding discrepancies and data entry processes. Provides superior customer service when handling research team requests and responding to questions. Guides research teams and investigators by encouraging best practices and assisting in the education of study team members on protocol-specific data entry requirements. Coordinates with research teams to prepare data for analysis and/or study completion. Verifies the accuracy and completeness of the information within various systems that support clinical trial operations. Reviews critical data fields in the OnCore Clinical Trials Management System to ensure accuracy and consistency with institutional and departmental policies. Performs quality control activities on data present in various systems to identify errors or discrepancies. Generates reports from various systems for comparison and to aid in the conduct of quality control processes. Required Skills / Abilities/Knowledge:Data Quality Analyst I
Complex problem-solving skills. An ability to work independently. Knowledge of clinical trial regulations and procedures, data management processes, and database-related technical skills. Data Quality Analyst II
In addition to the above, has progressed to performing more advanced quality control processes. Has a strong understanding of data management processes, and is able to resolve complex issues and questions independently. Able to provide input on overall data quality planning, procedures, and systems with an eye towards consistent improvement. Able to handle some projects independently, and work with Senior Data Quality Analysts and/or the Data Quality Manager on larger projects. Senior Data Quality Analyst III
In addition to the above, has progressed to performing larger and more complex projects independently. Demonstrates significant database management expertise, a strong understanding of internal procedures, and the relationship between connected systems and databases (e.g.InForm, OnCore, Epic, BOE, COE). Able to provide input on and assist the Data Quality Manager in drafting and revising departmental work instructions. Able to generate high-level reports and lead projects to completion. Supervisory Responsibilities:
Data Quality Analyst I & II: None Senior Data Quality Analyst III: No direct reports. May assist the Data Quality Manager with day-to-day oversight and training of more junior staff. May be responsible for independently managing projects that require collaboration among multiple analysts and delegation of assignments.

Keywords: Global Technical Talent, Boston , Data Quality Analyst, Professions , Boston, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Boston RSS job feeds