Description
We are recruiting for Clinical Data Manager for a Global Biotech who will be responsible for the management of oversight of activities outsourced to CROs. Provide support to GxP adherence, Inspection readiness, Protocols, SAPs and other relevant documents. You will undertake the accountability for Data Management KPIs.Responsibilities
- Lead the development of CRFs/eCRFs, edit checks, reconciliation plans, data communication plans, data transfers, SDTM packages and routine reports to track data collection/quality progress. Review of clinical study protocols and SAPs/mock TLFs. Provide input for high level forecasting of timelines for data management tasks and estimation of resources and budget.
- Strong technical expertise to ensure completeness, correctness and consistency of clinical data in all studies/programs to achieve results in agreement with defined quality specifications and timelines
- Manage and troubleshoot operational challenges and GCP compliance
- Promote standardization in collaboration with other colleagues to improve consistency across all programs.
- Track emerging trends and apply them to improve data management support across all programs.
- Collaborate effectively with cross-functional teams and external partners.
- Develop, review, update, and add SOPs as company/situations evolve when applicable.
- Interact proactively and solution orientated with other clinical functions
Requirements:
- Master's degree (or equivalent).
- 5-8 years of related industry experience within the functional area.
- Experience with web based Electronic Data Capture and data management systems
- Experience with CRO oversight
- Good knowledge of ICH and other relevant guidance documents (from FDA, EMA, …)
- Strong communication skills; verbal, written, and presentation.
- Highly motivated and enjoys working in a fast-paced environment.
- Strong organizational skills and the ability to prioritize and multi-task.
- Positive, flexible self-starter who thrives under pressure.
- Able to think out of the box and propose innovative approaches.
- Knowledge of CDISC including SDTM formats and specifications
Kontakt: Luchele Mendes
Michael Bailey International is acting as an Employment Business in relation to this vacancy.