Sr Data Manager

Company Overview
Senior Data Manager - Well Respected Global CRO Company

Job Description
 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;
 Database audit;
 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.

Requirements
 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.

日本大阪 地図

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