长沙招聘

Responsibilities
Position Title: Database Manager (CDS)
Zone / Line: CDS, CRDC/WRDC
Location: Shanghai/Wuhan, China
Career Ladder (Level):D1 - D3

Position Purpose
The Database Manager (DBM) works with Technical Process Lead (TPL), Alliance Partners, and Central/Analytical labs and the Clinical Assay Group (CAG) to manage and support one or more areas of activities related to database setup/study start up, electronic data processing, PK/PD data handling, lab references and data management for all assigned studies. Areas of activity include but are not limited to: developing data collection tools/instruments for paper or electronic study, processing and loading external data, evaluating new data providers for qualification, coordinating data file transferring, and managing documents from internal customer/external vendors. DBMs should familiar their supported systems (data management system, EDC, etc) and able to troubleshoot and provide rapid response for all database issues. DBM may also support data management in writing data listing and reporting for data quality check

Organizational Relationships:

*Direct reporting relationship to Technical Operation Group Lead within the technical operations in CDS/CRDC/ WRDC.
*Strong Partnerships with DM within Pfizer and technical functions with Alliance Partners and vendors.
*Partnership with other related functions as needed.

Resources Managed (budget and FTEs):
NA

Primary Duties:

General:
*Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
*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 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.

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 and PK/PD data acquisition.
*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 preparing the lab portion of the protocol or attend study team/lab vendor meeting and telecoms when needed.
*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 Analyst/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

EDC/Application Support Functions
*Provide EDC user/ application support
*Liaise with EDC provider for the system performance, implementation, maintenance and upgrades
*Involving the EDC system validation activities, when assigned
*Manage for study/site access in the EDC system
*Manage all the study setup and close-out activities
*Maintain user training records for the EDC system at Pfizer

DM Process and Support Functions
*Define, improve, and implement Pfizer DM processing
*Provide training for data management in CDS (CRDC and WHRDC)
*Support all DM activities from study setup, conduct and close-out
*Setup and Maintain department training curriculum for CDS (CRDC and WHRDC)

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 supplier


Training & Education Preferred:
*Bachelor's degree or equivalent experience in a scientific discipline is required.


Prior Experience Preferred
*Technical expertise and business experience in supporting clinical trials 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.


Technical Competencies
1.Data management expertise
*Knowledge of clinical development process including knowledge and understanding of the principles of GCP
*Knowledge of data management processes and principles in area of responsibility: Clinical 2.Database Development (especially as it relates to electronic data acquisition and supporting technologies)
*Organizational skills
*Works independently, receives instruction primarily on unusual situations
*Ability to organize tasks, time and priorities; ability to multi-task
3.Communication skills
*Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally
4.Technology management
*Knowledge/understanding of technologies to support data acquisition and data management
*Knowledge/understanding of tracking systems, document management systems; awareness of CFR 21 part 11
5.Problem solving
*Ability to work in ambiguous situations within teams to identify and articulate complex problems

Pfizer Senior Leader Core Competencies
1.Collaborative, supportive
*Ability to work successfully with others to ensure team effectiveness
2.Innovation
*Explores moderately complex methodologies; encourages and shares innovative approaches to build and maintain a competitive advantage
3.Influencing
*Lobbies key internal and external stakeholders to ensure delivery of project goals
4.Networking and Alliance Building
*Looks for opportunities for collaboration to help deliver project goals
5.Learning Organization
6.*Contributes to a learning environment by sharing knowledge and best practice within and across project teams
*Mentors other team members in core discipline
7.Flexibility
*Responds positively and constructively to changing situations
8.Tactical Thinking
9.*Develops and implements short- and mid-term study plans to deliver project team goals with limited support
10.Teamwork
*Ability to work independently and within a team
*Shows respect and support for all team members
*Works collaboratively with group members and contributes to positive intra- and inter-team relationships both locally and globally
*Delivers on commitments to project team
11.Initiating and Implementing change
*Advocates and encourages actions that improve existing approaches and systems.
12.Customer Focus
*Identifies and builds effective relationships with customers and other stakeholders.

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。