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Clinical Data Manager Position in Plainsboro, NJ 

 

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Wizsolution LLC is looking for a professional Clinical Data Manager to work on clinical research projects for our client.

General Responsibilities:As a Clinical Data Manager, the candidate will be mainly responsible for clinical data management, analysis and documentation. The specific  duties include but not limited to:

• Provide technical support to clinical data management activities across multiple clinical development programs, from planning, coordination to timely delivery of complete, high quality and reliable clinical trial data for internal decision making, regulatory approval and marketing acceptance.

• Develop and review  the Data Management Plan (DMP) and appendices, CFR, eCFR design, edit check specifications, data issue logs, and data review plans,  define and document the data quality review strategy for each clinical trial project, and enable  the quality review of patient data  supporting regulatory filings, publications and other high-profile study design activities.

• Gather data collection requirements from various systems/applications deployed to collect clinical trial data (eCRFs, ePRO, eCOA, etc.), including ensuring adherence to defined standards, and also responsibility for user acceptance testing to ensure high quality deliverables and inspection readiness at all times.  

• Coordinate activities with external vendors in developing systems/applications for clinical trial data collection to ensure quality and timely deployment. Perform data reviews in accordance with the DMP/QC Plan.

• Review clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations. 

• Contribute to EDC database (DB) specification process, EDC user guides and ensure clinical data within EDC in good quality, review User Acceptance Testing (UAT) summary report.

• Responsible data transfers between vendors and sponsor, reconciliation of external data, monitoring data clean-up process performed by CROs from study start-up through data archiving.   Coordinate the archiving of study databases and related documents. 

• Work closely with statistics and statistical programming team to analyze and solve data issues and support data review. 

• Collaborate with IT and implementation team (s) to address changes to Clinical database systems. 

• Participate in continuous improvement activities, define and implement the changes required to create an industry-leading clinical data capability, including electronic data capture, external data integration, ad-hoc analysis and end-to-end data standards.

 

Job requirements: at least Bachelor’s degree or higher in Health Informatics, Statistics or  Computer Science  with extensive knowledge of clinical data mapping and analysis, and database design.  Strong skills in developing Case Report forms (CRFs), Edit checks creation, data cleaning and query management, lab Data Reconciliation and SAE Reconciliation for clinical study project.  A Master’s degree is highly preferred.

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Business Operation & Management Analyst

Wizsolution LLC is looking for a full-time Business Operation & Management Analyst in its Plainsboro office, NJ.   

 

Specific duties to be performed by this position:

 

• Use statistical methods to collect, manage and interpret business data that assists and supports our management and marketing team with decision making, policy formulation and other managerial function on the company’s consulting projects and related services, etc. 

 

• Apply operations management and information systems techniques across a wide range of disciplines, including operations, sales/marketing, human resources, administration and finance, to define problems, identify performance measures, and perform root cause analysis to identify alternatives and recommendations to improve business performance measures.

 

• Use accounting and financial methodologies to prepare and analyze financial report as related to financial analysis (i.e. forecast, profit-and-loss and expenses) from the company’s business and organizational systems to provide financial-related strategy and budget variance, and to assist the company’s business operating more efficiently and effectively.   

• Prepare documents and diagrams/charts to illustrate and describe company business operations, performance review, financial condition, and present findings and recommendations for implementation of procedures or organizational changes. Create reporting tools to simplify company’s financial and operational objectives, compile financial data and prepare projection reports, forecasting models to assist on the company’s project proposals and pricing decision.

 

• Research and analyze factors that contribute or reduce profitability, assess risks and benefits, including the internal risks like business model, cost efficiency, operational procedures, financial management, and external risks like market volatility, market competitors, macroeconomic.   

 

• Analyze marketing data and key business data in quantitative and qualitative method by using professional SAS tools include SPSS and STATA; develop predictive marketing analysis models, advanced data analysis and customer segmentation methodologies, identify and interpret marketing trends in complex datasets.

 

This position requires that the candidate must possess at least bachelor’s degree or equivalent in Business Administration, Public Administration, Budgeting and Financial Management, Economics, or related fields, Master’s degree is highly preferred, extensive knowledge and strong statistical and analytical skills including business/financial managerial decision modeling and operations management methods.  

 

Send resume to info@wizsolu.com

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Statistician

Statistician (2 x openings) in Plainsboro, NJ: Develop, validate & support statistical models and SAS programs for analysis, management & reporting of clinical trials/business data, and generating TLGs and analytical reports. Req.: Master’s degree/equiv. in Statistics, Math, Financial Analysis & Risk Management or related,  proficiency with statistical modeling & data analysis using SAS tools. SAS Advanced Programmer Certificate. Send resume to Wizsolution LLC, 101 Morgan Lane, Suite 302, Plainsboro, NJ 08536.

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Wizsolution LLC is looking for a professional Statistician to work on our client’s clinical research projects.

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General Responsibilities: 

• Coordinate with project manager, assist in reviewing statistical analysis plan (SAP), study protocol, CRF, and analysis file specifications to ensure SAS codes are incompliance with the requirement of SAP and study protocol.  

• Manage, analyze and interpret safety and efficacy data that are collected during clinical trials, review data collection and management methodology and assure acceptability and scientific integrity of data collection and analysis through appropriate application of principles of statistics, probability theory and statistical methodology.

• Use statistical techniques to analyze the clinical data and generate Ad-hoc safety summary reports for review by research scientists and medical directors. Also be responsible for checking whether the data are out of range of any safety guidelines provided by FDA or other agencies. Communicate with project manager and notify client in a timely manner on any abnormal testing results. 

·       Provide SAS programming support for the preparation of integrated reports and FDA submission.

·       Develop and validate complex SAS programs, SAS macros to create tables, graphs and listings, generate and validate SDTM and ADaM datasets for multiple phase I- III studies, integrated Summary of Safety and Efficacy (ISS/ISE) for FDA submission. 

·       Provide SAS programming specifications for CDISC SDTM and ADaM datasets, including proper validation, testing and documentation.  

• Create and modify standard SAS macros for validation, analysis and generation of clinical reports; provide high quality statistical analyses support for the clinical trial studies using advanced statistical theory and SAS/STAT/MACRO/GRAPH/SQL techniques.  

• Participate in preparing clinical study results for FDA submissions using SAS; writing intense QC documentation for every stage of reporting from extraction to the final reporting of the tables. 

• In addition, communicate with project manager and assist in client's inquiries on clinical trial related statistical analysis with developing statistical techniques/tools.

 

 

Requirements:  at least bachelor’s degree or equivalent in Statistics, Applied Mathematics or related fields.  Master’s degree is highly preferred.   Extensive knowledge of statistics and its applications, Strong skills in statistical methods, SAS programming, data analysis and data reporting for clinical study.