Informationen zur Anzeige:
Director Data Management (m/f/d)
Eysins (Schweiz)
Aktualität: 20.05.2022
Anzeigeninhalt:
20.05.2022, Fresenius Kabi
Eysins (Schweiz)
Director Data Management (m/f/d)
Functional Goal:
Provision of data management expertise from study design to submission to Regulatory Authorities. On behalf of Fresenius-Kabi SwissBioSim, lead oversight of data management activities outsourced to external partners. Provide support to but not limited to CRO selection, GxP adherence, Inspection readiness, Protocols, SAPs and other relevant clinical study documents. Accountability for Data Management KPIs.
Main Tasks:
Strong technical expertise to ensure completeness, correctness and consistency of clinical and non 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 Biostatistics and other colleagues to improve consistency across all programs
Track emerging trends and apply them to improve data management support across all programs
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
Contribute to the development of electronic submission packages
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
Subject Matter Expert for audits and inspections
Participate in the selection process of CROs and provide oversight of outsourced activities
Collaborate effectively with cross-functional teams and external partners
Develop, review, update, and add SOPs as company/situations evolve when applicable
Other Tasks:
Provide timely feedback and solutions to management regarding staffing needs and individual performance
Recruit new staff, onboard and manage new employees as needed
Interact proactively and solution orientated with other clinical and non clinical functions
Master's degree (or equivalent)
10+ years of related industry experience within the functional area
Experience with web based Electronic Data Capture and data management systems
Experience with CRO oversight
Knowledge of SAS (basic use)
Experienced knowledge of CDISC (SDTM format)
Ability to think beyond the home function, identifying connections between different areas of the organization to see the broader perspective
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
Berufsfeld
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