会社名
非公開 No.RE181102
企業タイプ
外資系企業
職種
医薬品:臨床開発
仕事内容
<職務における成果責任>
1. Serves as point of contact for providing responses to internal audits as well as regulatory inspections with regard to data management activities
2. Serves as a local focal point to implement data conformance strategy as defined by Global DMM Standards involving submissions, acquisitions and divestitures of the data integrated into the CAL
3. For local assets, mitigates/arbitrates asset level data management technical and process issues with CROs, DMM and CDMM
4. Leads new Pfizer clinical/PMS data collection environment (i.e. NextGen Clinical Trials, No Paper CRF in PMS) by successful implementation and maintenance of the systems (e.g. NextGen CDMS, PMS CDMS) and related processes
5. Works with BPOs to review performance metrics against targets to ensure program deliverables are being met and productivity is aligned with Pfizer expectations
6. Works with global organizations to ensure appropriate data standards, system and processes are used and implemented consistently across the programs
7. Applies and drives lessons learned to continuous improvement of data management practices across the organization including internal customers and CROs
8. Leads implementation of PMS data collection standards into each surveillance
対象条件
【資格・能力要件】
・Education/Certification: Minimum of a Bachelor degree in biological sciences, statistics, IT, medicine or related field or experience in related scientific discipline.
・English Skill: Level at which s/he can discuss, debate, negotiate with global colleagues or external customers.
【職務経験】
・Approximately 10 years industry experience in order to have a thorough understanding of the processes associated with clinical drug development, PMS and operations (especially in supporting the data management components of regulatory submissions) as well as in developing/implementing new standards, systems and processes.
・People manager experience preferred
年齢
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