5 days old

Clinical Data Scientist

Pfizer
Tokyo
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**Position Purpose**



Serve as point of contact for data management strategy and operations as a member of Data Management & Monitoring (DMM) organization in Development Japan and provide central accountability for ensuring timelines and deliverables to be met with consistency, efficiency and quality.



**Description of Primary Role & Responsibility**



Ensures to achieve data management related goals in projects in time with quality



Serves as point of contact for providing responses to internal audits as well as regulatory inspections with regard to data management activities



Serves as a local focal point to implement data conformance strategy as defined by Global DMM organization



For local assets, mitigates/arbitrates asset level data management technical and process issues



Leads and ensure successful implementation and maintenance of Pfizer new data collection systems or modalities (e.g. new EDC, eCOA, device) and related processes with them Works with Business Process Owners to review performance metrics against targets to ensure program deliverables are being met and productivity is aligned with Pfizer expectations Works with global organizations to ensure appropriate data standards, system and processes are used and implemented consistently across the programs



Applies and drives lessons learned to continuous improvement of data management practices across the organization including internal customers and CROs



**Desired Behavioral and Technical Skills**



Behavioral Skills



Flexibility and implementing change: Responds positively and constructively to changing situations and manages change by identifying opportunities and coaching self and others through the change



Customer Focus: Identifies and build effective relationships with customers and other stakeholders



Ownership: Be accountable for data quality to internal and external customers to ensure confidence in data



Respect: Respects others and recognizes others achievements



Technical Skills



Clinical Data Management expertise: Extremely Extensive knowledge of clinical development process and principle including in-depth knowledge and understanding of the principles of GCP as well as CRF design, database design/set-up, query management, validation specs, non-CRF electronic data transfer from vendors, risk-based quality control and etc.



Communication: shares best practices and any visible and/or potential issues with appropriate members in timely manner



Experience



Industry experience in order to have a thorough understanding of the processes associated with clinical drug development and operations (especially in supporting the data management and reporting components of regulatory submissions and product defense) as well as in developing/implementing new standards, systems and processes



Education / Certification



Minimum of a Bachelor degree in biological sciences, statistics, IT, medicine or related field or experience in related scientific discipline



Language



Level at which s/he can discuss, debate, negotiate with global colleagues or external customers



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Medical



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Posted: 2021-06-07 Expires: 2021-07-08
Sponsored by:
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Clinical Data Scientist

Pfizer
Tokyo

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