长沙招聘

Position Purpose
? Responsible for ensuring the completeness, quality and integrity of the clinical databases in support of one or more areas of activities related to data entry and document processing, database setup, electronic data processing, PK/PD data handling, lab references and lab data management, data extract and reporting for all assigned studies.
? Areas of activity include but are not limited to: entering and verifying clinical data into corresponding clinical trial databases from images or electric files, developing data collection tools/instruments for paper or electronic study, processing and loading non-CRF/external data, evaluating new data providers for qualification, coordinating data file transferring, and managing documents from internal customer/external vendors.
? Ensure the consistent use and application of applicable data standards. The ultimate objective is to ensure data quality and consistency across programs and repositories.
? Ensure database management activities comply with regulations, applicable Standard Operating Procedures (SOPs) and Processes at all times.
? Familiar with supported systems (data management system, EDC, etc) and able to troubleshoot and provide rapid response for all database issues.
? Work with the global study team to meet the study objectives.

Resources Managed (budget and FTEs)
NA

Primary Responsibilities
General:
? Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
? Provide support for data entry, verification, and document process from images or electric files (i.e. case report forms, laboratory reports, translation data list).
? Perform activities and provide technical expertise to set up and test data collection including but not limited to electronic data collection (EDC), case report forms (CRFs), Patient Reported Outcome (PRO), electronic data loading, PK/PD data acquisition, medical lab normal ranges, randomization and data integration, etc.
? Create and write programs to assist data manager to ensure study data quality
? Plan and execute communication plans & methods to ensure customer satisfaction and enable improvements to be implemented during the course of a study.
? Able to resolve conflicts, influence and communicate with key stakeholders and customers.

Data and Document Process Functions:
? Enter clinical data into clinical database with minimal errors based on quality standards and maintain an acceptable level of productivity to assist in meeting project deadlines.
? Perform data entry (1st & 2nd pass), including corrections to ensure that data entered into database accurately reflects the data recorded on the CRF or according to project guidelines as assigned.
? Fulfill requirements for tracking or documenting work processed.
? Perform QC in accordance with data entry guideline and other project specific documents by comparing data listings to the data source (CRFs/hard copy documentation/scanned images) to establish accuracy rate.
? Resolve e-task and clean up Index Review queue on a daily basis.
? Communicate with Data Managers of all Pfizer Studies via e-mail and GCDStrack ticket to clarify standard eclipse process or execution of their request.
? Setup eclipse study specific structure and perform QC in accordance with ESS worksheet and give feed back to SSU with timelines for business continuity.
? Provide PGRD/PGP Submission Compilation Group with Case record documentation within given timelines.
? Ensure documents are properly labelled by drug, protocol, investigator, and subject, and that site personnel are aware of the requirements for submitting documents to Development Operations.
? Perform CRT & CXT QC in accordance with submission assembly guideline.
? Participate in the manual review of clinical data and identification and documentation of data errors, omissions and inconsistencies.
? Coordinate destruction of outdated, unnecessary confidential internal CDM and study specific documentation and prepares data for archiving.
? Follow instruction on document process and complete assignment in a timely matter.
? Perform other clinical trial data and document processing tasks as necessary to meet the needs of business.

Database Design Functions:
? Design, create and test clinical database to ensure database quality.
? Define investigator center assignments and patient positions in study database, and ensure consistency between the tracking database and the study database.
? Ensure data collection tools and databases align with the protocol and adhere to ICH GCP, SOPs, corporate standards and regulatory requirements.

eData Processing & PK/PD Functions:
? Work with Study Team to define the electronic data, PK/PD data, lab tests, and lab codes.
? Develop Data File Specifications, PK/PD Definition Files, and translator programs, create test plan, conduct UAT testing, load eData files, and maintain documentations for electronic data receipt
? Request reconciliation files from vendors and process files to retain the blind for PK/PD data management review.
? Work with Central/Analytical labs and Clinical Assay Group to troubleshoot issues related to sample collection, data transfer and management.

Medical Lab Functions:
? Coordinate data management and vendor interaction related to lab tests coding, unit conversion, and normal ranges setting for lab data integration, review, and reporting.
? Assist project teams in lab reference range page design, screen testing, and QC.
? Provide scientific knowledge and training about lab testing and clinical database to study teams, internal/external lab vendors when needed.
? Enter lab normal range, unit, unit conversion into EDC or data management system

Data extract and reporting/visualization Functions:
? Write, test and validate edit check programs to support data management in data cleaning and reviewing.
? Evaluate/Develop/implement data review tools or data visualization tools to support data management and clinical data review.
? Provide ad hoc reports requested from study teams and management for data quality, performance, progress and timeline.
? Integrate study data from various sources for data management and data cleaning
? Work closely with study teams, other DBMs and vendors

Randomization Functions
? Create, test, validate, distribute, maintain, update and archive Randomization Schedule for CRDC study
? Setup treatment schedule in data management system or EDC
? Support all breaking blind activities ( unexpected or planned study close) for CRDC study
? Liaise with pharmaceutical team for the drug tested.

Technical Skill Requirements
? Technical expertise and business experience in supporting clinical trials data entry, database development, data acquisition, medical lab data collection (lab tests, units, and normal ranges), etc.
? Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations.
? Project management skills and technical capabilities as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
? Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills.


Qualifications (i.e., preferred education, experience, attributes)
? Bachelor’s degree or above of equivalent experience in a scientific discipline required.

Preferred Additional Experience
? Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design
? Previous experience within a database management role, understanding key processes and principles associated with role including CRF design, database set-up, edit check specification, data transfer activities
? Knowledge of clinical trial database and its applications
? Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.)

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。