
QACE Data Coordinator I (4260)
DM CLINICAL RESEARCH GROUP • Karachi Division, Sindh, Pakistan
**Role & seniority: ** QACE Data Coordinator I (entry-level; ~1+ years relevant experience)
**Location & work type: ** Karachi (KHI), Sindh 75600 — Corporate role (work arrangement not specified)
**Stack/tools: **
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Clinical trial documentation and standards: ALCOA+, GDP, GCP, ICH-GCP, FDA regulations
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Data/issue systems: Query Management System
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Tools: Microsoft Excel / Google Sheets (spreadsheet reporting)
**Top 3 responsibilities: **
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Collect and review clinical research data from multiple sources to identify issues/inconsistencies affecting study quality or integrity.
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Capture and manage action items from site visits, sponsor audits, and remote monitoring; ensure timely escalation/resolution.
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Maintain compliance by reviewing source creation vs protocol/lab manual/pharmacy manual and updating central issue repositories; identify trends impacting outcomes.
**Must-have skills: **
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Knowledge of clinical research quality/compliance (ALCOA+, GDP, GCP; FDA/ICH-GCP).
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Root cause analysis and strong problem-solving.
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Attention to detail; ability to work independently and in teams.
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Strong communication, organization, and documentation skills.
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Proficiency with Excel/Sheets.
**Nice-to-haves: **
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Experience with clinical data management systems and auditing/quality assurance & control processes.
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Strong capability in trend/pattern detection and stakeholder com
Full Description
Job DetailsJob Location: Corporate - Karachi (KHI) - Karachi, Sindh 75600The QACE Data Coordinator I role is a critical position that requires the candidate to identify and investigate clinical related issues and trends which may impact study outcomes and/or study integrity. DUTIES & RESPONSIBILITIES Collect clinical research data obtained from various sources to identify issues and inconsistencies that could impact a study’s overall quality. Collaborate with teams, such as the regulatory, clinical data, and research site teams, to ensure all respective data is available. Review study data and accurately capture all action items, including those arising from scheduled site visits, sponsor audits, and remote monitoring. Communicate/escalate any issues that don’t have a satisfactory resolution Ensure the adherence to ALCOA+, GDP, GCP Standards, and FDA regulations with all relevant clinical trial documentation. Conduct review of source creation for clinical studies against applicable documents, such as, the study protocol, lab manual, and pharmacy manual. Add issues found on the query management system to keep a central repository of all items. Identify trends and patterns which may have a potential impact on study outcomes and communicate to stakeholders in a clear and concise manner. Submit required administrative paperwork per company timelines. Any other matters, as assigned by management. KNOWLEDGE & EXPERIENCE Education: Foreign Medical Graduate/PharmD/Clinical Research Professional/Advanced Degree in Health Science Experience: 1+ years experience in a functional clinic setting, demonstrating ability to handle clinical problem-solving skills. Experience with relevant regulations and guidelines (e.g., ICH-GCP, FDA regulations, ALCOA+). Experience with working with clinical data management systems and auditing processes. Experience in quality assurance and quality control in a clinical setting. Credentials: N/A Knowledge and Skills: Meticulous attention to details and deadlines. Knowledge of scientific methods, procedures, and techniques. Exceptional problem solving skills, and root cause analysis of issues. Ability to work independently and as part of a team. Strong communication, organizational, and interpersonal skills. Proficiency in spreadsheet software (e.g., Microsoft Excel, Google Sheets). KPI & Success Metrics Average minimum number of chart reviews per day= 5 per day Valid findings review percentage= 85% Paycom training completion by deadline= 95% Successful Priority task completion by deadline= 95% Qualifications