Job Summary
The Senior Clinical Data Coordinator (Sr. CDC) performs clinical data management activities supporting Phase I–III clinical trials in accordance with ICH, Good Clinical Practice (GCP), applicable regulatory requirements, Standard Operating Procedures (SOPs), and other relevant procedures and guidelines.
The Senior Clinical Data Coordinator is responsible for ensuring the completeness, accuracy, consistency, and quality of clinical trial data throughout the study lifecycle. The Sr. CDC works closely with Clinical Data Managers, Clinical Operations, Safety, Clinical Database Programmers, Biostatistics, Medical teams, sites, and third-party vendors to support timely delivery of high-quality clinical data and study deliverables.
Essential Functions And Responsibilities
- Perform ongoing clinical data review to identify missing, inconsistent, incomplete, or potentially erroneous data and support timely discrepancy resolution.
- Perform reconciliation of third-party data streams and Serious Adverse Events (SAEs) with the appropriate clinical and safety databases.
- Generate, review, track, and follow up on data queries to support timely data cleaning and resolution.
- Perform User Acceptance Testing (UAT) of clinical databases, including execution of test scripts, documentation of results, and verification of fixes.
- Perform Quality Control (QC) of clinical databases, data management activities, and related study deliverables.
- Support the review and validation of database functionality, edit checks, data validation rules, and other database components.
- Maintain and perform ongoing updates to Data Management-related documentation and study-specific materials, as required.
- Support Clinical Data Managers with data cleaning, reconciliation, database freeze/lock activities, and other study milestones.
- Collaborate with Clinical Operations, Safety, Clinical Database Programming, sites, and third-party vendors to resolve data-related issues and maintain data quality.
- Monitor data review, query, reconciliation, and other assigned activities to ensure study timelines and deliverables are met.
- Maintain accurate documentation of data review, reconciliation, UAT, QC, and other assigned activities in accordance with applicable procedures.
- Ensure all assigned activities are performed in compliance with ICH/GCP, applicable regulations, SOPs, study protocols, and client requirements.
Minimum Qualifications And Requirements
- Minimum of 3 years of clinical data management or clinical data coordination experience is required.
- Bachelor’s degree in Life Sciences, Health Sciences, Clinical Research, Pharmacy, Nursing, or a related discipline is preferred.
- Certification in a related allied health profession from an appropriately accredited institution (e.g., RN, MT, PA, RT) is preferred.
- Individuals with equivalent relevant clinical research or clinical data management experience may be considered in lieu of the educational requirements.
- Demonstrated experience working with Electronic Data Capture (EDC) systems is required.
- Experience with Oracle InForm™ EDC is preferred.
- Experience supporting Phase I–III clinical trials is preferred.
- Experience with clinical data review, query management, data cleaning, and discrepancy resolution is required or strongly preferred.
- Experience with third-party data reconciliation and/or safety database reconciliation is preferred.
- Experience performing User Acceptance Testing (UAT) of clinical databases is preferred.
- Experience performing Quality Control (QC) of clinical databases and/or clinical data management deliverables is preferred.
- Oncology and/or inflammatory therapeutic area experience is preferred.
- Familiarity with ICH/GCP guidelines and applicable clinical research regulations is preferred.
- Experience working in a Clinical Research Organization (CRO), pharmaceutical, biotechnology, or FSP environment is preferred.
Preferred Technical And Professional Skills
- Strong understanding of clinical data management processes and the clinical trial lifecycle.
- Working knowledge of clinical database structures, eCRFs, edit checks, data validation, query management, and database cleaning processes.
- Strong analytical and problem-solving skills with the ability to identify discrepancies, investigate potential data issues, and determine appropriate next steps.
- Strong attention to detail and commitment to data accuracy, integrity, and quality.
- Ability to effectively manage multiple tasks and competing priorities while meeting study timelines and deliverables.
- Strong written and verbal communication skills with the ability to interact effectively with cross-functional teams, sites, vendors, and other stakeholders.
- Proficiency with Microsoft Office applications, particularly Excel, Word, and PowerPoint.
- Ability to work independently with appropriate guidance while contributing effectively as part of a multidisciplinary study team.
- Demonstrated ability to proactively identify potential issues, communicate risks, and escalate concerns appropriately.
- Familiarity with clinical data standards and industry practices, including CDISC standards, is desirable.
Skills: clinical data management,cdisc standards,edc systems,clinical data coordinator
