Senior Manager Data Management

Job Location(s) CN-Dalian
Job Number
Job Category
Clinical Data Management
Position Type

Job Overview

+  Serveas the technical leader.
+  Develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
+  Identify and implement solutionsto data management issues and concerns, incl uding proactive prevention strategies based on metricsand forecasts.
+  Serve as the project and client liaison incl udi ng provision of project specific data managementstatus, cycle time, and productivitymetrics.
+  Coordi nate and pa1ticipate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications.
+  Prepare data acquisition conventions and data review guidelines I diagnostic specificationsconsistent with the clinical data model, statisticalanalysis plans,and CRF (eCRF) completion I
monitoring conventions. Coordinatethe development and testing of data management system edit I datavalidation checks (diagnostics) and special l istings I procedures used as tools for the data review and discrepancymanagement activities.
+  Interact and collaborate with other project and specialtyteammembers (clinical operations,Biometrics, CDM technicalsuppmt, drug safety,etc.) to suppo1t the set-up, maintenanc e,and
closureof the data management aspects of the project to ensure consistent, cohesive data handling and quality.
- Maintain productivityand quality indicators.
+  Assist in the formulation of short-tennand long-term strategiesto improve peoject data management efficiencies, through collaboration with senior management.
+  Supervise, mentor and evaluate performan ce of staff to ensure career development,interpersonal skills, and achievement of competency standards.
- Oversee the technical performance of the staff on achievi ng client satisfaction through deliveryof quality data, on-time and on-budget.
- Mai ntain technical data managem entcompetencies via paitici pation in internal and external training semi nars.
- Assist with the development execution of training programs and ensure staffare trained andadhere to project-specific, global, standardized data management processes.+  Identify areas for process and efficiency improvement and implement solutionson assigned projects.
- +  Suppo1trecruitment of new potential Data Management candidates.
- Support global standardization of data management processes and process improvement andefficiency and ensure standardsare applied at the local site.+  Create action plans to address staff quality and performance issues identified by clients, viaclient satisfactionsurveys, and/or from core project team feedback.+  Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as necessary.+ Review literature and researchtechnologies/procedures for improving global data management practices.
- +  Suppmt business development for data management time and cost estimates and prepare andpresent to potential clients on global data managementcapabilities.
- +  Manage utilization and billability of staff,planning for resource allocation I recruitment basedon individual skills, competencies, and availability.
- +  Suppott development of global, harmonized SOPs and specific quality processes andprocedures for data management activities.
- Perform other duties as assigned by management.


+  University/college degree (life science,pharm acy or related subject preferred), or ce1tification
i n a related allied healthprofession from an appropriatelyaccreditedinstitution (e.g., nursing ce1tification, medical or laboratory technology).
+  Additional relevantworkexperience willbe consideredin lieu of formalqualifications.
- Broad knowledge of drug development process.+  Thorough knowledge of effective clinical data management practices.+ Thoroughknowledgeof lCH Guidelinesand GCP including international regulatoryrequirements for the conductof clinicaldevelopment programs, especiallyas relatedto data handlingand processing.
- +  Thorough knowledge ohime and cost estimatedevelopmentand pricing strategies.
- +  Understanding of globalclinical development budgets and relationshipto productivity targets.


+ Minimum seven (7) yearsrelevantwork experience with approxi mately four (4)years supervisoryexperience to incl ude data management, clinical operations, andknowledge of severaltherapeutic areas.
+  Demonstrated skillfor technical and supervisoryleadership of 8-15 staffwithin oneor more
locationsin a region.
+   Excellent oralandwritten communication and presentationskills.
+   In depth knowledge of clinical trial processand data management, clinical operations,biometrics , quality management, and systems applications to supportoperations.
+   Jn depth knowledge of tracking of staffproductivityand qua!itymetrics.
+   Demonstrated skillfor mentoring and developing staff on technical andcore competencies.
+   Working knowledge of therelationshipand regulatoryobligation of the CRO industry withpharmaceutical I biotechnological companies.
+   Operational experience in other disciplinessuchas clinical,biometrics, medical writing,pharmacovigilance, safety, quality assurance, regulatory, etc.
- Demonstrated ability to leadby example teamson strategies and achievementof depa1tmentgoals,objectives, and initiatives andto encourage team memberstoseek solutions.
- +   Strong leadershipand interpersonal skills.


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