南京招聘

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.

简历收集邮箱：zhihong.jiang@pfizer.com

辉瑞公司（Pfizer Inc.）创建于1849年，迄今已有160多年的历史，总部位于美国纽约，是目前全球***的以研发为基础的生物制药公司。辉瑞致力于运用创新的科学技术以及全球资源来改善每个生命阶段的健康和福祉。
我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
2012年辉瑞公司全年合计收入590亿美元，研发投入78亿美元。辉瑞在全球拥有9万多名员工，59家生产基地，业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。
目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域，同时其卓越的研发和生产能力处于全球领先地位。
在人类和动物药品的发现、开发和生产过程中，辉瑞始终致力于奉行严格的质量、安全和价值标准。每天，分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。
辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作，支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来，辉瑞一直努力为人们提供更好、更优质的服务。
辉瑞生物制药目前在华上市的创新药物已超过50个，其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗，辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。
辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓，并以其优异的品质深受广大消费者的青睐；辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.