Sr External Data Specialist

Job Location(s) CN-Beijing | CN-Shanghai
Job Number
Job Category
Clinical Data Management
Position Type

Job Overview

Essential Job Duties:
- Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardizeddata management processes (SOPs, Work Instructions, ) 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 I correction to the data
- Interact with the dictionary coding and maintenance group to ensure appropriate process set­up and
- Perform reconciliation of the clinical and safety
- Perform reconciliation of central laboratory and/or third party vendor data (eCRF,eDiary, specialty laboratory, ).
- 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 i nvestigation.
- Apply quality control procedures and checks to ensure data quality standards (client and Covance) are achieved .
- Serve as a reviewer of project documents such as protocols, CRFs (or eCRFs and eDiary), monitoring conventions, CRF (eCRF) completion guidelines,
- Assist with the developmentof [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 clinicaldata model and/or database design and annotate the CRF (eCRF) according to these
- Assistin the creation of data acquisition conventions and data review guidelines I diagnostic specification s consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion I monitoring conventions.
- Assist in the development and testing of data management system edit I data validation checks (diagnostics) and special listings I procedures used as tools for the data review and discrepancy management acti vities.
- Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical suppmt, drug safety, etc.)to suppmt the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
- Serve as client contact for project meetings and CDM status updates .
- Potentially support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
- Suppo1t the training of project staff on project-specific, global, standardized data management processes.
- Maintain technical data management competencies via participation i n internal and external training seminars.
- Review literature and research technologies/procedures for improving global data management practices.
- Perform other d uties as assigned by management.


Minimum Required:
-  University/college degree (life science,pharmacy or related subject preferred), orce1tificationin a relatedalliedhealth profession from an appropriately accredited institution (e.g.,nursingce1tiftcation, medicalor laboratory technology).
- In l ieu of the aboverequirement,approximately 18 months experience in related field (e.g.pharmaceutical, laboratory, data analysis) i ncorporating approximately one year'sclinicaldata management experiencei n addition to the four (4) years relevant work experience in data management willbe considered.
- Broad knowledge of drug development process.Understand ingof global clinicaldevelopment budgetsand relationship to product ivitytargets.
- Knowledgeof effective clinicaldata management practices.+ Thorough knowledge of lCH Guidelines and GCP including international  regulatory requirementsfor the conductof clinicaldevelopment programs.
- Cursory knowledgeof time and cost estimatedevelopment and prici ng strategies.


Minimum Required :
- Minimum four (4)yearsrelevant work experience withincreasing responsibility in data management with knowledge of two (2) or more therapeutic.
- Demonstrated time management skill and abilityto adhereto project productivity metrics andtimel ines.   
- Excellent oral andwritten communicationskills and demonstrated presentation skill.
- Knowledgeof clinicaltrial process anddata management, clinicaloperations, biometrics,quality management, and systems applications to support operation
- Workingknowledge of therelation ship and regulatory obligation of the CRO i ndustry with pharmace uticalI biotechnologicalcompanies.
- Potentialability to lead byexampledatamanagement. 
- Demonstrated abilityto work in a team environment and collaboratewith peers.
- Demonstrated interpersonalskills.


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