1+ months

R&D/ / Clinical Data Scientist (Exempt/Non

**/ Description of Primary Role & Responsibility**

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

**/ Qualifications**

**/ Desired Behavioral and Technical Skills**

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

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

- 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 builds effective relationships with customers and other stakeholders

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

- Knowledge in Clinical Development and Reexamination: Extensive knowledge of clinical development process and principle including the principles of GCP, GPSP and GVP

- Clinical Data Management expertise: Extensive knowledge of CRF/database design, database set-up, validation specs, query management, medical coding, SAE reconciliation, data browsing tools and outsourcing

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

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

We are working on internal and external non-smoking enlightenment and support activity. For this reason, please refrain from applying for smokers.

Office Worker (Japan)

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


Posted: 2019-07-10 Expires: 2020-07-17

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

R&D/ / Clinical Data Scientist (Exempt/Non


Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast