Job Description

Position Summary

Reporting to the Program Manager/Site Coordinator, the Data Manager is responsible for the quality and management of data collected in accordance with multiple HIV Prevention Trials Network (HPTN) and HIV Vaccine Trials Network (HVTN) protocols. S/he will oversee quality control (QC), quality assurance (QA), and continuous quality improvement (CQI) activities related to data collection, entry, and cleaning for participant screening, enrollment, and follow-up in studies conducted at the Harlem Prevention Center (HPC). S/he will: establish and oversee plans and procedures for internal QC/QA of study documents including data cleaning and management; implement an integrated process for ensuring the quality of data in compliance with each study protocol and related study-specific procedures; liaise with external statistical and data management centers (SDMC) and clinical research sites as required by study procedures and funding requirements; ensure that all data submission timelines are met and data queries are responded to in a timely manner; and oversee steps to prepare for sponsor and FDA audits.

Other activities include conducting cross-sectional and longitudinal analysis for data that are analyzed at the site to monitor progress to targets and inform quality improvement activities, prepare manuscripts, reports, funding applications, and other documents utilizing study data, and other duties as assigned.

Responsibilities

• Conduct all research activities in accordance with study protocols, site standard operating procedures, and other appropriate institutional regulations, procedures, and policies, including procedures to safeguard confidentiality of study participants. – 5%
• Develop procedures to implement QC/QA plans for multiple simultaneous studies conducted at the site. – 5%
• Maintain database to track the collection, submission, and cleaning of study data. – 5%
• Devise standardized tools to record QC/QA findings and oversee the peer review process. 5%
• Ensure timely submission of data to the network’s SDMC. – 5%
• Review data quality control reports for errors as well as periodic reports for delinquencies/unanswered queries or warnings with study staff. Respond promptly to all data queries. – 10%
• In collaboration with the site leader, site coordinator and study staff, develop and implement the Clinical Quality Management Plan (CQMP) for all data collection, review and submission activities. – 5%
• Using the CQMP, identify problem areas with data collection, report findings to the site leadership and the study staff, and develop appropriate corrective and preventative measures. – 5%
• Collaborate with other study staff and oversee daily activities related to data QC/QA and CQI. – 5%
• Perform real time QC of all study related activities and retrospective systematic periodic QA reviews of all study related activities for the same indicators used by the independent monitoring agency under contract to DAIDS in coordination with study staff. – 15%
• Prepare the site’s bi-annual Quality Assurance Summary Report (QASR), and report findings to DAIDS in consonant with their specific requirements (i.e., bi-annually or by protocol specific requirements), and at DAIDS discretion. – 5%
• Review and update the site’s Data Management SOP annually, or if needed. Prepare study-specific Data Management SOP, if required. – 5%
• Ensure that all corrective and preventative measures are consistently implemented. – 5%
• Coordinate and prepare on-site external monitoring and audit activities with the study staff, site coordinator and site leader. – 5%
• Ensure that sponsor requirements for data submission and audits are met. – 5%
• Other activities include conducting cross-sectional and longitudinal analysis for data that are analyzed at the site, preparation of manuscripts, reports, funding applications, and other documents utilizing study data, participate in the development and writing of abstracts, presentations, reports, proposals, and other material. – 5%
• Perform other related duties as directed – 5%

Minimum Qualifications

• Bachelor’s degree in public health, social sciences, or related discipline or equivalent in education, training &/or experience
• Three years of experience or equivalent combination of education, training &/or experience
• Proficiency in SAS statistical software
• Excellent scientific writing skills
• Proficiency in the Microsoft Office Suite (Word, Excel, PowerPoint)
• Demonstrated ability to work both independently and as part of a team
• Attention to detail and strong organizational, writing and communication skills
• Excellent interpersonal skills

Preferred Qualifications

• Master’s degree in public health, social sciences, or related discipline
• Background in public health and HIV research
• Experience managing multiple large databases in accordance with sponsor requirements
• Experience in and multistep analysis of large data sets, including model building
• Experience supporting or leading peer-reviewed articles

How to Apply

Job Categories: Equal Opportunities. Job Types: Full-Time. Salaries: Not Disclosed.

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