Job Description
- Bachelor’s Degree required. Life sciences, Pharmacy or relevant fields preferred.
- 2+ years of experience in Clinical Data Review tasks
Must have:
- Good Knowledge of clinical data management activities.
- Good understanding and expertise in clinical data listings review.
- Experience in Vendor Data reconciliation including Local lab review.
- Strong Understanding and expertise in Query Management
- Ability to perform User Acceptance Testing (UAT) for data review listings.
- Experience in Freezing and Locking of CRFs
- Knowledge and experience of EDC systems (Medidata RAVE preferred)
- Excellent oral and written communication skills
- Skilled in Veeva vault documentation.
Nice to Have:
- Knowledge of ICH-GCP guidelines regulatory guidelines/regulations.
- Knowledge of third-party reconciliations like SAE Reconciliation, Protocol Deviation and Questionnaire review.
- Basic understanding of study build aspects like CRF design and Edit Check build for efficient data review.
- Ability to perform UAT of screens and edit checks for appropriate discrepancy management.
- Understanding of all key stakeholders and their role/responsibilities across projects.
- Communicate effectively with cross-functional teams.
- Knowledge of general clinical research including Investigator site processes.
- Basic Understanding of 21CFR Part 11 and data privacy as they apply to data handling and the use of computer systems in clinical research.”
Responsibilities will include, but are not limited to:
- Understand and review Protocol along with relevant data review documents (e.g. Protocol Data Review Plan, Data Quality Management Plan) Review clinical data listings.
- Manage and facilitate resolution of data discrepancies.
Perform data cleaning as per the defined Clean Patient Group. Freezing & Locking of CRFs/Fields. - Coordinate with Data Management Lead for study deliverables.
- Complete review of loaded external data.
- Track data load and address discrepancies.
Coordinate with external data vendor for resolution of data discrepancies as applicable.
Filing of appropriate documents in eTMF as per eTMF master plan.”
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
