Responsibilities
1. Clinical Data Review and Insights
- Conduct thorough reviews of clinical data to identify insights at the patient level and analyze trends.
- Support activities like Interim Analysis, Database Lock, and Post Lock, facilitating timely resolution of data issues.
- Collaborate with relevant teams to enhance clinical data quality, emphasizing subject safety, eligibility, data integrity, trend detection, issue resolution, and identifying cases for medical review.
2. Data Review and Quality Strategy Development
- Contribute to the creation of the Data Review/Quality Plan (DRP/DQP) and the overall data review strategy.
- Ensure consistent implementation of protocol-level elements such as deviations, eligibility criteria, study assessments, and other key protocol components.
3. Support in Data Capture and CRF Development
- Collaborate with relevant teams on developing Case Report Forms (CRFs).
- Assist in implementing data capture tools to ensure accurate and efficient data collection.
4. Contribute to and facilitate data review process improvements e.g. identification of delinquent/redundant reports and/or implementation of innovative data analysis processes and tools.
5. May contribute (in collaboration with relevant line functions) to the development of study-level documents, including clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. In collaboration with relevant line functions, review/write clinical trial documents for study CSR activities, and publications.
Qualifications
Monthly based
Accra, Greater Accra Region, Ghana
Accra, Greater Accra Region, Ghana