|職名||Sr Data Manager|
|勤務地||Japan - Osaka|
Senior Data Manager - Well Respected Global CRO Company
Strong oral and written communication skills, with ability to communicate effectively throughout all levels of the organization.
Demonstrated capability to set clear priorities and effectively manage multiple projects.
Pharmaceutical or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA & PMDA
Participate in the review of Clinical research documents (eg. Protocols, Case Report Forms);
Develop Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements;
Create and maintain Data Validation Plan;
Create Data Entry Guidelines;
Create Data Handling Plan;
Create Data Transfer Specification;
Develop and review Case Report Form (CRF), electronic and/or paper;
Develop database (DB) clinical trial data specifications, including CRF annotation, edit rules/checks, query logic and data validations;
Perform external data reconciliation in collaboration with programmers;
Develop test scripts and execution logs for User Acceptance Testing (UAT);
Perform training on study trials and create user guides;
Perform database lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock;
Coordinate the archiving of study databases and related documents;
Perform SAE reconciliation;
Perform other activities as required;
Provide mentorship to junior members;
Working with project manager and cross functional team members to maintain project timeline and overall quality of deliveries.
Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
Working knowledge of Clinical database applications.
Bachelor’s degree in clinical/pharmacy/biological/mathematical sciences or related field or nursing degree.
At least 2 years data management and/or related work experience in a medical device or pharmaceutical industry/company is preferred.
Ability to solve problems and work independently with general direction.