Covance

Senior Clinical Data Manager (全国)

Job Location(s) CN-Beijing | CN-Shanghai | CN-Dalian | CN-Guangzhou
Job Number
2021-70030
Job Category
Clinical Data Management
Position Type
Full-Time
Telecommute
Yes

Job Overview

+ Serve as the technical leader on all data management aspects for project(s) including stait-up, maintenance, and completion activities.
+ Develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
        +Identify and implement solutions to project data management issues and concerns,
        including proactive prevention strategies based on metrics and
+ Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.
+ Coordinate and paiticipate i n the development of the clinical data model and/or database design and annotate the CRF (eCFR) according to these specifications.
+ Review data acquisition conventions and data review guidelines I diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completionI monitoring conventions.
+ Coordinate the development and testing of data management systems edit I data validation checks) diagnostics) and special listings I procedures used as tools for the data review and discrepancy management activities.
+ Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical suppo1t, drug safety, etc.) to suppo1tthe set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handlingand quality.
      + Advanced planning and risk management for projects (issueescalation, resource management).
+ Oversee the technical pe1formance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
    +  Assist with goal creation and performance review assessment for data review project staff.
+ Maintain technical data management competencies via pa1ticipation in internal and external training seminars.
+ Ensureproject staff are trained and adhere to project-specific, global, standardized data management processes.
+ Identify areas for process and efficiency improvement and implement solutions on assigned projects.
+ Support achievement of project revenue and operating marginfor data management activities to agreed targets.
+ Develop and maintain strategic client relationshipsand receive clientsatisfaction surveysand implement appropriate action plans as necessary.
        + Support business development for data management time and cost estimates and
         prepare and present to potential clients on global data management capabilities.
       + Perform other duties as assigned by management.
        + Review literature and research technologies/procedures for improving global
          data management practices.

Education/Qualifications

Minimum Required:
- University/collegedegree (life science, pharmacy or related subject preferred), or certification
- in a related allied healthprofession from an appropriately accredited institution (e.g., nursingce11ification, medical or laboratory technology).
- Additional relevant work experience will be considered in lieu of formal qualifications.
- Broad knowledge of drug development processes.
- Understanding of global clinicaldevelopment budgets and relationship to productivity targets.
- Knowledge of effective clinicaldata management practices.
- Knowledge oftime and cost estimate development and pricing strategies.
- Thorough knowledge of TCH Guidelines and GCP including international regulatoryrequirements for the conduct of clinical development programs,especially as related to datahandling and processing.

Experience

Minimum Required:
 
+ Minimum five (5) years relevant workexperiencein data managementwith approximatelyone (1) yeartechnicalsupervisoryexperience toinclude data management,clinicaloperations, and knowledgeof severaltherapeuticareas.
- Demonstrated skill fortechnicalmanagement of staff exceeding 5 employees.
- Financialmanagementof gross revenuesin excess of $250K per
- Excellentoraland writtencommunication and presentation skills.
- In depthknowledge of clinicaltrialprocess and datamanagement,clinicaloperations,biometrics,qualitymanagement,andsystemsapplications to supportoperation
- Workingknowledgeof the relationship and regulatoryobligationof the CRO industry withpharmaceuticalI biotechnologica
- Ability to lead by example teams on project strategies and achievement of depa11ment goals,objectives, and initiatives and to encourage team members to seek solutions.
- Demonstrated managerialand interpersonal skills

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