Clinical Data Specialist
Há 3 dias
Our organization is seeking a skilled Clinical Data Manager II to play a key role in ensuring data quality and integrity across multiple clinical trials. The successful candidate will be responsible for leading the data management team, developing and implementing data management plans, and collaborating with cross-functional teams to ensure timely and accurate data delivery.
About the Role:- Oversee the development and maintenance of clinical databases, including data review and cleaning during study conduct and preparation for database lock/close.
- Develop and implement data management plans, ensuring compliance with Good Clinical Practices (GCP) and ICH Guidelines.
- Provide training and support to site users and monitors on the clinical database, ensuring seamless data capture and transfer.
- Bachelor's or Master's degree in a related field of study.
- 10 years of clinical data management experience in the pharmaceutical industry or CRO environment.
- 5 years of experience as a lead data manager.
- Extensive experience working with EDC systems, preferably Medrio and Medidata Rave.
- Strong organizational and project planning skills.
- Excellent verbal and written communication skills in English.
- Knowledge of CDISC SDTM/CDASH standards and regulatory requirements.
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