Clinical Research Data & Systems Manager

THOMAS EYE GROUP PC•Atlanta, GA

1d•Hybrid

About The Position

The Clinical Research Data and Systems Manager owns the integrity of research data and the platforms that hold it across the full study portfolio. The position combines multi study clinical data management with administration of the research technology stack, placing accountability for the record and for the system that produces the record with one person. The incumbent sets data standards across studies, oversees the quality of what coordinators enter, administers the clinical trial management, electronic regulatory, and electronic data capture environments, maintains validation and 21 CFR Part 11 compliance, and produces the operational reporting used by research leadership. This is an individual contributor role with substantial functional authority.

Requirements

Bachelor degree in life sciences, health informatics, information systems, business, or a related field, or an equivalent combination of education and directly relevant experience.
One to three years in clinical research data management, clinical systems administration, health information systems, or project management within a regulated environment.
Demonstrated ownership of a system, dataset, or program, meaning accountability for outcome rather than task participation.
Working proficiency with relational data concepts and advanced spreadsheet capability, and the ability to write clear procedural documentation.
Demonstrated ability to hold vendors and internal stakeholders to committed timelines.
Ability to maintain strict confidentiality of protected health information and research data.

Nice To Haves

Three to five years of relevant experience, including direct clinical research experience at a site, sponsor, or CRO, and administration experience with a CTMS, eRegulatory, or EDC platform.
Working knowledge of 21 CFR Part 11, ICH E6(R3), and HIPAA as applied to research data, and computer system validation experience.
Project management credential such as PMP or CAPM, or professional certification such as CCRC, CCRP, or CCDM.
Reporting tool experience such as Power BI or Tableau, and SQL or Python capability.

Responsibilities

Own the quality, completeness, and timeliness of clinical data across all active studies, from source capture through database lock support.
Establish site wide source documentation standards, monitor data entry timeliness and query aging across studies, and intervene where standards are not met.
Oversee reconciliation of laboratory, imaging, external record, adverse event, and investigational product data.
Serve as the site point of contact for sponsor and CRO data management counterparts and coordinate database lock and close out readiness.
Conduct risk based quality control review of source and case report form data on a documented schedule, focused on the critical to quality factors identified per protocol under ICH E6(R3).
Deliver data standards training and direct coaching to coordinators and research assistants, and prepare corrective and preventive action documentation for data findings.
Serve as the site data and systems subject matter expert during sponsor audits and regulatory inspections.
Serve as system owner and administrator for site controlled platforms, including the clinical trial management system, electronic regulatory system, reporting environment, and secure file transfer.
Own user access lifecycle management across all platforms, including provisioning aligned to delegation, prompt deprovisioning, and documented periodic access review.
Configure study builds, visit schedules, budget grids, and milestone tracking.
Lead platform implementations and upgrades from requirements through user acceptance testing, training, and go live, and manage vendor relationships and system documentation.
Maintain a risk based computer system validation approach, 21 CFR Part 11 compliance including audit trail review and access controls, documented vendor qualification, and data security, backup, and retention arrangements.
Maintain inspection readiness for the data and systems domain and support HIPAA compliance for research data.
Build and maintain operational reporting on enrollment, conversion, data entry lag, query aging, deviation trending, and financial milestone status.
Produce and present the monthly research operations report, and provide performance data supporting feasibility responses and site qualification.
Maintain study startup project plans and lead defined process improvement projects with measured results.