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China Dev

Pfizer


Location:
Chaoyang Qu, Beijing Shi 100096
Date:
02/06/2018
2018-02-062018-03-09
Pfizer
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Job Details

Monitoring







+ Conduct SDV and ensure clinical trials data are submitted to data management in a timely fashion.



+ Identify issues that may impact on the conduct of the study and ensure appropriate closure of all issues. Management of Investigator Sites



+ Proactively manage a greater investigator site workload commensurate with experience, so that studies are run efficiently, and key study objectives are met.



+ Ensure studies are run in line with ICH/GCP, local laws and Pfizer SOPs and procedures.



+ Ensure patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements.



+ Inform the PI and site staff of all issues.



+ Agree and develop corrective and preventative actions with PI and site personnel to close all open issues.



+ Responsible for all aspects of site management from collaboration on site selection to study closeout.



+ Train site staff on the protocol, protocol amendments and Pfizer processes.



+ Understand the product, the protocol and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team.



+ Interact with health care professionals in a manner, which enhances Pfizer's credibility with the customer. Data Quality



+ Ensure that data monitored meets target quality standards.



+ Ensure that data is entered into Pfizer systems in a timely manner. Reporting



+ Report on progress of all studies at the investigational site after each visit to ensure that all relevant personnel are aware of progress against plan and any issues that have occurred.



+ Ensure all issues are correctly identified and catalogued.



+ Proactively manage issues to appropriate closure.



+ Maintain accurate site-level information on corporate clinical trials registry. Documentation



+ Obtain critical information to enable generation of IIP documentation.



+ Assist CTA in gathering IIP documentation where required to ensure timely site set up.



+ Maintain the SMF and SMF log.



+ Ensure ELARA and/or PTMF is complete and accurate.



+ QC relevant documents in ELARA and/or PTMF in a timely manner.



+ Generate site monitoring reports.



+ Maintain all appropriate monitoring logs.







Qualification



At least 1 year CRA experience



Demonstrated knowledge of quality and regulatory requirements across a range of different countries.



Demonstrated knowledge of clinical trial methodology and the drug development process, related to monitoring clinical trials, GCP, FDA, or country-specific regulatory environment.



Demonstrated success in prior scientific/technical/administrative management roles.



Maintain knowledge and expertise on all relevant SOPs.



Ability to communicate effectively and appropriately with internal and external stakeholders.



Attention to detail evident in a disciplined approach to document training, adherence to SOPs, forecast to spend tracking, metrics, etc.



Works independently. Receives instruction primarily on unusual situations.



Ability to organize tasks, time and priorities of self and others; ability to multi-task.







C:Plant Clock Standard - (China)



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