Trial Master File (TMF) Study Owner
辉瑞（中国）研究开发有限公司
- 公司规模：10000人以上
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2012-09-07
- 工作地点：上海-浦东新区
- 招聘人数：4
- 学历要求：本科
- 职位类别：临床协调员 生物工程/生物制药
职位描述
Position Title: Trial Master File (TMF) Study Owner
Reports to: Group Lead CTPQ China
Assignment Duration: Permanent/Contractual
Zone / Line: China R&D Center (CRDC), Development Operations (DevOps)
Location: Shanghai, China
Career Ladder (Level): D1/D3 Predicted Grade(s):
Position Purpose
The Trial Master File Study Owner is the single point of contact for the Project Manager (and Study Team regarding the TMF. The TMF Owner is accountable to the Project Manager for all global trial master file responsibilities conducted internally as well as externally at Alliance Partners (APs) and CROs. Oversight includes ensuring standardization, training, quality, cost effectiveness, and timely clinical trial documentation across the clinical program. The clinical trial documentation must be consistent with the Trial Master File Specifications, submission/inspection readiness criteria and comply with applicable SOPs and other requirements. The TMF Owner will ensure the consistent use and application of standards. The TMF Owner will act as a TMF subject matter expert across all business partners in document content, technologies, and processes. The ultimate objective is to ensure a complete and accurate Trial Master File through documentation quality and consistency across programs.
Organizational Relationships:
Interfaces with, Development Operations, Business/Research Unit colleagues, APs and other partners, Partner Lines, and other TMF Owners to share lessons learned.
Reports to Group Lead CTPQ China
Partners with core team members to resolve document discrepancies, ensuring a supportive and collaborative relationship
Partners with other Development Operations and non-Development Operations functions and key stakeholders.
Resources Managed (budget and FTEs):
Manages relationships with APs and/or CROs. TMF Processing colleagues / contractors.
Primary Duties:
? Develops and assists with the implementation of the Trial Master File specifications.
? Ensure Trial Master File project specification details are consistent with program level plans and milestones.
? Ensure that performance against project specifications are in alignment with program strategy.
? Ensure that the Trial Master File specifications and inspection readiness strategy are consistent across the program and meet minimum standards.
? Ensure consistent use of standardized processes and technologies across programs.
? Serve as point of contact for internal and external audits of Trial Master File related processes and activities.
? Review document quality data and audit outputs to identify trends across the programs to ensure quality documentation.
? Ensure documentation flow across the program is within projected timelines and intervene to implement corrective actions.
? Actively identify continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis.
? Review metrics to monitor performance against targets to ensure program deliverables are being met and productivity is aligned with PFE expectations.
? Capture lessons learned and share across Business/Research Units and Programs
? Apply lessons learned to continuous improvement of documentation management practices within a program and Business Process Improvements (BPIs), as applicable
? Develop and maintain Business/Research Unit-specific knowledge base within document management practice
? Ensure consistency in vendor specifications and efficient utilization of appropriate vendors to achieve and maintain standardization and efficiency across programs.
? Serve as point of contact for providing responses to regulatory authorities with regard to documentation management activities for audits, regulatory submission issues, and product defense.
? Ensure that the program documentation supports the regulatory package requirements
? Serve as point of contact to Project Manager for document management strategy involving acquisitions of new projects.
? Work with Manager to develop resource strategies to achieve program goals effectively utilizingAPs and CROs.
Clinical Study Start-up/Study Conduct/Study Close-out
? Determine and review study specific TMF specifications to ensure quality and standardization is established per program and kept up to date as program/protocols progress.
? Assess impact of potential changes to TMF specifications prior to implementation; collaborate with Project Manager if modifications are necessary.
? For fully outsourced studies, provide project and documentation specific selection criteria for CTPQ components with a CRO. Support study team with CRO selection and help establish a contract/work order with the CRO for the document management pieces. For trials not outsourced, collaborate with study team to ensure complete Trial Master File specifications are in place.
? Review audit reports and document metrics for trends and to ensure that program document management deliverables are on target.
? Support the preparation of appropriate audit responses
? Support project team in the effective management of external vendors including CROs.
? Analyze error trends in documentation and provide feedback, to enable continuous improvement.
? Support study team to ensure document quality requirements are agreed to and met, prior to reporting.
? Ensure all timelines and quality goals are met.
? Support study team in addressing/reporting regulatory queries pertaining to document management.
? Ensure complete TMF is in place at time of study close/submission.
Training & Education Preferred:
In general, candidates for this job would have the following levels of experience:
Minimum of Bachelor's degree or equivalent required.
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 effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
Experience with the following applications types:
? Electronic documentation management systems
? Web based data management systems, as required
? Database utilization
Outstanding 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.
Extensive knowledge of vendor processes and best practices in document management is necessary.
Must be capable to build strong relationships with application and service providers.
Leadership, project management, resource management (staff and financial), administrative, and technical capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both internal and external to the organization.
Experience supporting regulatory submissions and inspections preferred.
Strong skills in negotiation and conflict resolution essential. Ability to remain calm and focused in high-stress situations 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
Hands-on experience with electronic documentation management systems.
Experience in management of medical/clinical study records and documentation
Experience/knowledge of ICH/GCP documentation requirements
Technical Competencies:
Competency Detail / Comments (specific skills, etc.)
? Document management expertise
? Organizational skills
? Communication skills
? Project/process management
? Clinical development process
? Administrative excellence
? Clinical/Scientific aptitude
? Technology management
? Budget / expense management
? Decision Making
? Problem solving ? 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
? Works independently. Receives 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 document collection and archiving, 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:
Competency Detail / Comments (specific skills, etc.)
? Collaborative, supportive
? Innovation
? Influencing
? Networking and Alliance Building
? Learning Organization
? Flexibility
? Tactical Thinking
? Teamwork
? Initiating and Implementing change
? Customer Focus
? Work successfully with others to ensure team effectiveness and demonstrate Pfizer values
? Explores, implements and utilizes novel, moderately complex methodologies; encourages and shares innovative approaches to build and maintain a competitive advantage
? Lobbies key internal and external stakeholders to ensure delivery of study goals
? Ability to influence and negotiate to achieve win-win solutions.
? Looks for opportunities for collaboration to help deliver study goals and acts upon them
? Contributes to a learning environment by sharing knowledge and best practice within and across study teams. Mentors other team members in core discipline.
? Responds positively and constructively to changing situations
? Develops and implements 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.
? Works collaboratively with group members and contributes to positive intra- and inter-team relationships both locally and globally; deliver on commitments to study team and line
? Advocates and encourages actions that improve existing approaches and systems.
? Proactively manages change by identifying opportunities and coaching self and others through the change
? Identifies and builds effective relationships with customers and other stakeholders.
Reports to: Group Lead CTPQ China
Assignment Duration: Permanent/Contractual
Zone / Line: China R&D Center (CRDC), Development Operations (DevOps)
Location: Shanghai, China
Career Ladder (Level): D1/D3 Predicted Grade(s):
Position Purpose
The Trial Master File Study Owner is the single point of contact for the Project Manager (and Study Team regarding the TMF. The TMF Owner is accountable to the Project Manager for all global trial master file responsibilities conducted internally as well as externally at Alliance Partners (APs) and CROs. Oversight includes ensuring standardization, training, quality, cost effectiveness, and timely clinical trial documentation across the clinical program. The clinical trial documentation must be consistent with the Trial Master File Specifications, submission/inspection readiness criteria and comply with applicable SOPs and other requirements. The TMF Owner will ensure the consistent use and application of standards. The TMF Owner will act as a TMF subject matter expert across all business partners in document content, technologies, and processes. The ultimate objective is to ensure a complete and accurate Trial Master File through documentation quality and consistency across programs.
Organizational Relationships:
Interfaces with, Development Operations, Business/Research Unit colleagues, APs and other partners, Partner Lines, and other TMF Owners to share lessons learned.
Reports to Group Lead CTPQ China
Partners with core team members to resolve document discrepancies, ensuring a supportive and collaborative relationship
Partners with other Development Operations and non-Development Operations functions and key stakeholders.
Resources Managed (budget and FTEs):
Manages relationships with APs and/or CROs. TMF Processing colleagues / contractors.
Primary Duties:
? Develops and assists with the implementation of the Trial Master File specifications.
? Ensure Trial Master File project specification details are consistent with program level plans and milestones.
? Ensure that performance against project specifications are in alignment with program strategy.
? Ensure that the Trial Master File specifications and inspection readiness strategy are consistent across the program and meet minimum standards.
? Ensure consistent use of standardized processes and technologies across programs.
? Serve as point of contact for internal and external audits of Trial Master File related processes and activities.
? Review document quality data and audit outputs to identify trends across the programs to ensure quality documentation.
? Ensure documentation flow across the program is within projected timelines and intervene to implement corrective actions.
? Actively identify continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis.
? Review metrics to monitor performance against targets to ensure program deliverables are being met and productivity is aligned with PFE expectations.
? Capture lessons learned and share across Business/Research Units and Programs
? Apply lessons learned to continuous improvement of documentation management practices within a program and Business Process Improvements (BPIs), as applicable
? Develop and maintain Business/Research Unit-specific knowledge base within document management practice
? Ensure consistency in vendor specifications and efficient utilization of appropriate vendors to achieve and maintain standardization and efficiency across programs.
? Serve as point of contact for providing responses to regulatory authorities with regard to documentation management activities for audits, regulatory submission issues, and product defense.
? Ensure that the program documentation supports the regulatory package requirements
? Serve as point of contact to Project Manager for document management strategy involving acquisitions of new projects.
? Work with Manager to develop resource strategies to achieve program goals effectively utilizingAPs and CROs.
Clinical Study Start-up/Study Conduct/Study Close-out
? Determine and review study specific TMF specifications to ensure quality and standardization is established per program and kept up to date as program/protocols progress.
? Assess impact of potential changes to TMF specifications prior to implementation; collaborate with Project Manager if modifications are necessary.
? For fully outsourced studies, provide project and documentation specific selection criteria for CTPQ components with a CRO. Support study team with CRO selection and help establish a contract/work order with the CRO for the document management pieces. For trials not outsourced, collaborate with study team to ensure complete Trial Master File specifications are in place.
? Review audit reports and document metrics for trends and to ensure that program document management deliverables are on target.
? Support the preparation of appropriate audit responses
? Support project team in the effective management of external vendors including CROs.
? Analyze error trends in documentation and provide feedback, to enable continuous improvement.
? Support study team to ensure document quality requirements are agreed to and met, prior to reporting.
? Ensure all timelines and quality goals are met.
? Support study team in addressing/reporting regulatory queries pertaining to document management.
? Ensure complete TMF is in place at time of study close/submission.
Training & Education Preferred:
In general, candidates for this job would have the following levels of experience:
Minimum of Bachelor's degree or equivalent required.
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 effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
Experience with the following applications types:
? Electronic documentation management systems
? Web based data management systems, as required
? Database utilization
Outstanding 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.
Extensive knowledge of vendor processes and best practices in document management is necessary.
Must be capable to build strong relationships with application and service providers.
Leadership, project management, resource management (staff and financial), administrative, and technical capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both internal and external to the organization.
Experience supporting regulatory submissions and inspections preferred.
Strong skills in negotiation and conflict resolution essential. Ability to remain calm and focused in high-stress situations 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
Hands-on experience with electronic documentation management systems.
Experience in management of medical/clinical study records and documentation
Experience/knowledge of ICH/GCP documentation requirements
Technical Competencies:
Competency Detail / Comments (specific skills, etc.)
? Document management expertise
? Organizational skills
? Communication skills
? Project/process management
? Clinical development process
? Administrative excellence
? Clinical/Scientific aptitude
? Technology management
? Budget / expense management
? Decision Making
? Problem solving ? 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
? Works independently. Receives 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 document collection and archiving, 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:
Competency Detail / Comments (specific skills, etc.)
? Collaborative, supportive
? Innovation
? Influencing
? Networking and Alliance Building
? Learning Organization
? Flexibility
? Tactical Thinking
? Teamwork
? Initiating and Implementing change
? Customer Focus
? Work successfully with others to ensure team effectiveness and demonstrate Pfizer values
? Explores, implements and utilizes novel, moderately complex methodologies; encourages and shares innovative approaches to build and maintain a competitive advantage
? Lobbies key internal and external stakeholders to ensure delivery of study goals
? Ability to influence and negotiate to achieve win-win solutions.
? Looks for opportunities for collaboration to help deliver study goals and acts upon them
? Contributes to a learning environment by sharing knowledge and best practice within and across study teams. Mentors other team members in core discipline.
? Responds positively and constructively to changing situations
? Develops and implements 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.
? Works collaboratively with group members and contributes to positive intra- and inter-team relationships both locally and globally; deliver on commitments to study team and line
? Advocates and encourages actions that improve existing approaches and systems.
? Proactively manages change by identifying opportunities and coaching self and others through the change
? Identifies and builds effective relationships with customers and other stakeholders.
公司介绍
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。
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。
联系方式
- Email：ChinaCPWTalent@Pfizer.com
- 公司地址：1 (邮编：200000)