Beschreibung
The Senior Clinical Data Manager leads and/or supports the execution of data management activities necessary for the generation of hypothesis and for decision making in research or development phases, and for the preparation of submission data and required documentation for regulatory authorities and the greater clinical research community. The Senior Clinical Data Manager may assume the business role of a Study Data Manager in one or more clinical studies. In this capacity, s/he serves as the primary contact for Data Management on the Core Study Team.Serves as the key subject matter expert on topics related to data management activities including specific activities and processes in early clinical development phases. Contributions include, but are not limited to: vendor selection and management, mentoring junior staff, training team members, leading or contributing to expert working groups (e.g., QSD initiatives), presenting best practices at internal and external industry meetings meetings/congresses, and participating in due diligence assessments.
Governs use of key data management elements across studies in assigned projects: assumes ownership of development and maintenance of Medical Standards relevant to the area of responsibility; contributes to the definition of data structure standards; review applied results of the Important Medical Event (IME) List and, medical coding conventions.
- Assumes operational and/or oversight responsibility as Study Data Manager for all assigned internal and outsourced studies, and apply Data Management best practices
- Accountable or a contributor for CDM deliverables from protocol creation until release of data for analysis.
- Ensure CDM input and contributions to Risk Management (risk identification, risk communication, incorporation of risk in risk management plan, implementation of risk mitigation activities in relevant plans)
- Incorporates and maintains Medical Standards in clinical studies for all elements of the medical standards package.