Pfizer Tech Sup, TMF Study Owner in Wuhan, China
Why Patients Need You Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
What You Will Achieve It is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility. You will play an important role in processing, reviewing and receiving clinical data and records and from therapeutic groups as well as internal and outside investigators. You will ensure that accurate, timely, and consistent data reaches the clinical teams and other groups. You will be relied on for data management plans, including data preparation and validation activities, among others.
As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing important deliverables on time. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.
It is your commitment and hard work that will help make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Manage own time to meet agreed targets; develop plans for work activities on own projects within a team.
Serve as Data Manager for one or more clinical trials assuming responsibility for Data Monitoring and Management (DMM) activities.
Ensure operational excellence in collaboration with partners and colleagues for application of standards and develop data cleaning reports in support of the data review plan.
Ensure operational excellence across all Data Monitoring and Management (DMM) deliverables.
Set-up and test data review listings to verify the quality and completeness of data as specified in Data Management Plan by reviewing data attributes populated by general users.
Ensure lessons learnt during the study are documented and shared with other study teams to facilitate cross-study learning.
Build good relationships with local and global SMEs from different fields, leverage their expertise in areas such as systems and process and proactively identify issues and work to create solutions.
Subject Matter Expert to and single point of contact for the Project Manager (PM) or equivalent and Study Team to ensure a complete and accurate TMF through documentation quality and consistency across clinical trials and programs.
Accountable to the PM or equivalent for all global Trial Master File responsibilities conducted internally as well as externally at Alliance Partners (APs) and Contract Research Organizations (CROs).
To provide crucial TMF quality support to the Study Team and to establish a proactive quality-focused partner-relationship with the Study Team.
3+ years' experience
Demonstrated knowledge of data management processes and principles
Experience with web based data management systems
Working knowledge of electronic document management systems
Knowledge of International Conference on Harmonization and more specifically Good Clinical Practices
Thorough understanding of the processes associated with clinical study management and regulatory operations
Ability to manage tasks, time and priorities
Demonstrated effective verbal and written communication skills and adapt communications to audience
Relevant pharmaceutical industry experience
Experience using data visualization tools
Proficient experience using commercial clinical data management systems and/or EDC products
Awareness of regulatory requirements and relevant data standards
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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