Forward-thinking team leader skilled at operating departments efficiently to meet goals. Proactive and hardworking individual focused on continuous operational improvement. Looking to bring acquired vast knowledge in Operations Management into the Clinical Research sphere as a Clinical Data Manager.
KEY COMPETENCIES
Good comprehension of CDISC guidelines, ICH-GCP GCDMP and 21 CFR Part 11 guidelines
Sound knowledge on Clinical trial phases (Phase I to IV)
Good understating on Clinical Data Management activities
Knowledge of End-to-end CDM process (Study start Up, Study conduct and Study close out)
Complete Knowledge of validation procedures and discrepancy management and DCF
Designing of Electronic Case Report Forms (eCRF)
Extend comprehensive knowledge of study protocol and other relevant study documentation
Knowledge of Data Management Plan and CRF Completion Guidelines
Extensive knowledge in EDC (Electronic data Capture)
Trained on SAE reconciliation and Third Party Vendor Data reconciliation
Freezing and Locking Activities
TECHNICAL SKILLS