Job Summary

We are seeking an experienced Clinical Data Analyst III (CDA III) to independently lead clinical data validation and data management activities across clinical studies. The role requires expertise in clinical data review, reconciliation, database quality control, risk identification, study start-up support, and cross-functional collaboration. The successful candidate will act as a Subject Matter Expert (SME), mentor junior team members, and contribute to process improvements while ensuring compliance with ICH-GCP guidelines and regulatory requirements.

Key Responsibilities

Independently perform and lead clinical data validation, cleaning, review, and reconciliation activities throughout study conduct and database lock.
Manage data queries and conduct manual and SAS-generated listing reviews.
Perform reconciliation of external vendor data and ensure data integrity across systems.
Identify project risks, highlight delivery concerns, and support mitigation planning.
Support the preparation and maintenance of Data Management documentation and Trial Master File records.
Lead User Acceptance Testing (UAT) activities for clinical database setups.
Review study protocols, EDC screens, and database configurations.
Provide input into data management timelines and coordinate operational activities during study start-up.
Track and review CRFs and support data entry activities as required.
Perform quality control reviews and ensure compliance with SOPs, ICH-GCP guidelines, and regulatory requirements.
Act as a mentor and provide on-the-job training to Clinical Data Analysts.
Serve as a Subject Matter Expert (SME) for data management tools, systems, and processes.
Support continuous improvement initiatives and implementation of project-specific tools and efficiencies.
Provide operational metric analysis and support scope change assessments and resource planning.
Act as backup to the Data Management Lead when required.

Required Skills

Strong leadership and collaboration skills with the ability to coordinate global and virtual teams.
Ability to independently interact with sponsors and stakeholders regarding data issues and study requirements.
Strong negotiation, influencing, and stakeholder management skills.
Advanced problem-solving and root cause analysis capabilities.
Exceptional attention to detail and commitment to first-time quality.
Strong organizational, prioritization, and time-management skills.
Excellent written and verbal communication skills.
Effective presentation and knowledge-sharing abilities.
Adaptability and ability to work in dynamic, fast-paced environments.
Strong mentoring and coaching skills.

Technical Requirements

Strong experience with Clinical Data Management Systems such as Medidata Rave, Oracle InForm, Veeva, DataLabs, or ClinBase.
Advanced understanding of clinical data management processes, including data cleaning, reconciliation, and database lock activities.
Expertise in database setup activities and data validation specifications.
Knowledge of MedDRA and WHODrug coding dictionaries.
Understanding of CDISC standards.
Basic knowledge of SAS and programmed listings.
Strong knowledge of ICH-GCP guidelines, clinical research regulations, and industry best practices.
Experience leading virtual data management teams across global studies.

Qualifications

Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related healthcare discipline.
Relevant experience in Clinical Data Management within the clinical research or CRO industry.