长沙招聘

Responsibilities
Position Purpose(ADM02):
The Registry Quality Control Head manages staff responsible for critical functions related to ensuring the integrity of the Registry. Functions include management of Quality Control and data entry workload and the monitoring of metrics, and policies/procedures for all Registry data attributes This includes running Quality Control reports; review of potential data quality issues; entry, modification or deletion of data attributes; quality metrics collection; day to day operations and management of associated staff. The Registry Quality Control Head will also create, maintain and assume accountability for a culture of high customer service using tools to facilitate communication, clarity of workload balance, and alignment within and across functional lines.

Organizational Relationships(ADM02):
Reports directly to the Head - Wuhan Research and Development Center
Dotted line reporting relationship to the Registry Business Process Owner

Resources Managed (budget and FTEs) (ADM02):
25 Data Stewards

Major Duties (ADM02):
General
oSupervise the departmental staff in the daily management of Quality Control Reports. Organize and prioritize daily workload for review of the reports and discussion with study teams on needed corrections, as well as data entry into the CTMS as needed.
oEnsure adequate training of staff on Registry/CTMS procedures and policies related to Registry Data Quality guidelines and quality metrics.
oEvaluate and implement strategies to ensure consistent processes and procedures for the CTMS application in collaboration with CTMS Council Chair and the Registry Process Owner.
oImplement organizational design and develop succession planning for group.
oDevelop people, including recruitment, retention, and career development and performance management.
oReview metric dashboards, trending reports and quality sampling reports to understand the overall health of the Registry and identify issues and opportunities for re-training.

Training & Education Preferred(ADM02):
In general, candidates for this job would have the following levels of experience:

Minimum of Bachelor's degree or equivalent required.

Clinical Trial Management System and industry experience in order to have a thorough understanding
of the processes associated with the conduct of clinical trials and data entry operations.

Project management, resource management, administrative, and technical capabilities are required, as
well as a strong background in managing and leading people. Effective verbal and written communication
skills in relating to colleagues and associates both inside and outside the organization.

Experience with the following applications types is preferred:
*Clinical Trial Management Systems
*Web based data management systems, as required
*Database utilization

Excellent English verbal and written communications skills, combined with outstanding listening skills are
required.

History of achievement in a customer service role with demonstration of meeting customer needs and
concerns.

History of achievement in building strong customer relationships.

Experience supporting regulatory submissions and inspections preferred.

Strong skills in negotiation and conflict resolution essential. Ability to remain calm and focused in a high
stress situation is very important.

Strong background in provision of high levels of customer service evidenced by positive feedback from
customers

A sound knowledge of working across international boundaries and cultures.

Prior Experience Preferred(ADM02):
Hands-on experience with Clinical Trial Management Systems
Experience with medical/clinical study records and documentation
Experience/knowledge of ICH/GCP requirements
Previous experience leading/managing a group responsible for Clinical Trial Management Systems and/or clinical study management function, or equivalent
Detail / Comments (specific skills, etc.)
*Extensive knowledge of clinical development process, including in depth knowledge and understanding of the principles of GCP
*Extensive knowledge of Clinical Trial Management Systems and data requirements
*Understanding of the Registry and its components

*Work independently. Receive instruction primarily on unusual situations
*Ability to organize tasks, time and priorities of self and others; ability to multi-task.

*Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally

*Ability to manage studies and processes to agreed quality and timelines

*Knowledge of the clinical development process, understand concepts of Phase I-IV and principles of study design

*Attention to detail evident in a disciplined approach to document maintenance and management

*Understanding of scientific/clinical principles, and ability to work across different therapeutic areas

*Extensive knowledge/understanding of technologies to support data attribute collection, awareness of CFR 21 part 11

*Understands and has ability to efficiently manage budgets

*Ability to make complex decisions that require choosing between multiple options and have the potential to impact the delivery of the program/project and resource on the program/project.

*Ability to work in ambiguous situations within the team to identify and resolve complex problems.

Behavioral Competencies(ADM02):
Detail / Comments (specific skills, etc.)

*Ability to plan and implement activities to raise the quality of the department.
*Ability to encourage and convince other departments to review and improve quality.

*Work successfully with others to ensure team effectiveness and demonstrate Pfizer values

*Explore, implement and utilize novel, moderately complex methodologies; encourages and shares innovative approaches to build and maintain a competitive advantage

*Lobby key internal and external stakeholders to ensure delivery of study goals

*Ability to influence and negotiate to achieve win-win solutions.

*Identify opportunities for collaboration to help deliver study goals and acts upon them

*Contribute to a learning environment by sharing knowledge and best practice within and across study teams. Mentors other team members in core discipline.

*Respond positively and constructively to changing situations

*Develop and implement short- and mid-term study plans to deliver study team goals with limited support

*Ability to work independently and within a team; shows respect and support for all team members.

*Work collaboratively with group members and contribute to positive intra- and inter-team relationships both locally and globally; deliver on commitments to study team and line

*Advocate and encourage actions that improve existing approaches and systems.
*Proactively manage change by identifying opportunities and coaching self and others through the change

*Identify and build 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。