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headhunter推荐某外资CRO公司（北京）诚聘临床数据管理
DM Manager/Supervisor
名额：1名
工作地点：北京大望路
要求：项目管理经验丰富，带团队经验，3年以上临床数据管理员经验
待遇：20-25K
Senior CDC
名额：2名
工作地点：北京大望路
要求：项目管理经验丰富,培训经验，3年以上临床数据管理员经验
待遇：13-17K
CDC II
名额：3-4名
工作地点：北京大望路
要求：项目经验，2年以上临床数据管理员经验
待遇：9-12K
CDC I
名额：3-4名
工作地点：北京大望路
要求：项目经验，1年以上临床数据管理员经验
待遇：7-9K
Job Description
Job Specifications
Job Title: Clinical Data Coordinator I/II/Sr. CDC
Department Name: Phase II/III Clinical Data Management, Clinical Development Services
The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job.
I. Job Summary:
• Serve as a member of the project team with primary responsibility for clinical data review, query generation / resolution and reconciliation activities to support the delivery of clinical data according to client quality and integrity specifications, and project timelines and productivity targets.
• Potential to assist in the development of the project Data Management Plan, including the creation of data acquisition conventions and data review guidelines / diagnostics specification; and set-up of the data management systems according to project requirements.
• Potential to serve as the technical data management leader on small projects with technical oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, and project timelines and budgets.
Essential Job Duties:
• Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data
• Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data
• Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database
• Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application
• Perform reconciliation of the clinical and safety databases
• Perform reconciliation of central laboratory and/or third party vendor data (eCRF, eDiary, specialty laboratory, etc.)
• Perform aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, etc.), and/or data inconsistencies that require further investigation
• Apply quality control procedures and checks to ensure data quality standards (client and Covance) are achieved
• Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRFs and eDiary), monitoring conventions, CRF (eCRF) completion guidelines, etc.
• Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data
• Assist in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications
• Assist in the creation of data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions
• Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities
• Potentially interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality
• Potentially serve as client contact for project meetings and CDM status updates
• Support the training of project staff on project-specific, global, standardized data management processes
• Perform other duties as assigned by management.
Principal Contacts and Scope of Communications
.
• Internal:
- Biometric Programmers
- Clinical Data Management Study Design and Programming
- Project Teams, including Clinical Research Associates
- Project Management
• External:
- Client representatives
- Any vendor that is providing information for a clinical trial including Covance Clinical Laboratory Services
• Speaking: __X__ Yes (English)
• Writing/Reading: _X___ Yes (English)
II. Experience:
Minimum Required:
• Minimum two (2) years relevant work experience with increasing responsibility in data management with knowledge of one (1) or more therapeutic areas.
• Demonstrated time management skill and ability to adhere to project productivity metrics and timelines
• Potential ability to lead by example data management staff
• Demonstrated ability to work in a team environment and collaborate with peers
• Demonstrated interpersonal skills.
• Excellent oral and written communication skills
• Ability to demonstrate a constructive problem solving attitude while dealing with time demands, incomplete information or unexpected events
III. Education/Qualifications/Certifications and Licenses
Minimum Required:
• University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
• In lieu of the above requirement, approximately 18 months experience in related field (e.g. pharmaceutical, laboratory, data analysis) incorporating approximately one year’s clinical data management experience in addition to the two (2) years relevant work experience in data management will be considered
• Knowledge of drug development process
• Knowledge of effective clinical data management practices
• Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
• Fluent in English, both written and verbal
IV. Competencies:
Required:
• Core Competencies:
 Focus on Customers
 Innovate and Change
 Pursue Scientific and Process Excellence
 Work with Others
 Achieve Results
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发表于 2011-12-31 13:50:40
