东莞招聘

Responsibilities
Position: Manager, Trial Master File (TMF) Processing Center
Report To: Head of Pfizer Wuhan R&D Center (WRDC)
Zone / Line: Development Operations
Location: BioLake, Wuhan

Position Purpose

The Manager of TMF Processing Center manages staff responsible for critical functions related to ensuring the integrity of the Trial Master File (TMF). Functions include management of document flow/workload and the monitoring of metrics, and policies/procedures for all TMF documents. This includes scanning documents, processing of documents, user and retrieval support, quality metrics, day to day operations and management of associated staff. The TMF Manager, Processing Center 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

*Reports directly to Head of Pfizer Wuhan R&D Center
*Dotted line reporting relationship to the TMF Director

Resources Managed

*Manage direct reports and TMF Processing Center team members.

Major Duties

*Supervise the departmental staff in the daily handling of TMF documents. Organize and prioritize daily workload for receipt, preparation, and processing of documents received by the processing center.
*Ensure adequate training of staff on TMF procedures and policies related to document scanning and processing, quality metrics, and document retention for TMF documents.
*Evaluate and implement strategies to ensure consistent processes and procedures for the TMF application in collaboration with the TMF Director and TMF Process Owner.
*Implement organizational design and develop succession planning for group.
*Develop people, including recruitment, retention, and career development and performance management.
*Review metric dashboards, trending reports and quality sampling reports to understand the overall health of the TMF and identify issues and opportunities for re-training.
*Liaise with TMF Study Owners regarding the overall completeness and management of the TMF

Training & Education Preferred

*Minimum of Bachelor's degree or equivalent required.

Prior Experience Preferred

*Clinical Documentation Management and industry experience in order to have a thorough understanding of the processes associated with the conduct of clinical trials and document management 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:
- Hands-on experience with electronic documentation management systems
- Web based data management systems, as required
- Database utilization
*Experience in management of medical/clinical study records and documentation
*Experience/knowledge of ICH/GCP documentation requirements
*Previous experience leading/managing a group responsible for clinical document management and/or clinical study management function, or equivalent
*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.

Technical Competencies

*Document management expertise
- Extensive knowledge of clinical development process, including in depth knowledge and understanding of the principles of GCP
- Extensive knowledge of TMF and document requirements
- Working knowledge of electronic document management systems
- Understanding of the Trial Master File and its components
*Organizational skills
Work independently. Receive instruction primarily on unusual situations
Ability to organize tasks, time and priorities of self and others; ability to multi-task.
*Communication skills
Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally
*Project/process management
Ability to manage studies and processes to agreed quality and timelines
*Clinical development process
Knowledge of the clinical development process, understand concepts of Phase I-IV and principles of study design
*Administrative excellence
Attention to detail evident in a disciplined approach to document maintenance and management
*Clinical/Scientific aptitude
Understanding of scientific/clinical principles, and ability to work across different therapeutic areas
*Technology management
Extensive knowledge/understanding of technologies to support document collection and archiving, awareness of CFR 21 part 11
*Budget / expense management
Understands and has ability to efficiently manage budgets
*Decision Making
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.
*Problem solving
Ability to work in ambiguous situations within the team to identify and resolve complex problems.

Behavioral Competencies

*Quality Awareness
Ability to plan and implement activities to raise the quality of the department.
*Collaborative, supportive
Ability to encourage and convince other departments to review and improve quality
*Collaborative, supportive
Ability to encourage and convince other departments to review and improve quality
*Innovation
Work successfully with others to ensure team effectiveness and demonstrate Pfizer values
*Influencing
Explore, implement and utilize novel, moderately complex methodologies; encourages and shares innovative approaches to build and maintain a competitive advantage
*Networking and Alliance Building
Lobby key internal and external stakeholders to ensure delivery of study goals
*Learning Organization
Ability to influence and negotiate to achieve win-win solutions
*Flexibility
Identify opportunities for collaboration to help deliver study goals and acts upon them
*Tactical Thinking
*Teamwork
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
*Initiating and Implementing change
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.
*Customer Focus
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.

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.