Pfizer Tech Supervisor, DM in Wuhan, China
Ensure that all data components are conducted in compliance with GCP, relevant SOPs, and regulatory requirements.
Ensures Conformance to the applicable Pfizer Data Standards.
Perform complete data management activities from SSU to Study closeout to Study Data Reporting.
Support relevant continues improvement initiatives in data management.
Including all hands on Data Management responsibilities
Develop the Data Management Plans (DMP) to ensure data completeness and accuracy.
Support CDS to deliver data management deliverables in term leading the daily DM activities
Accountable for the implementation of all data activities for the responsible studies.
Review protocols to ensure the data collection, database and reporting requirements can be met and are standardized
Responsible to develop the database / CRF as well as DMP following the final protocol and applicable standard.
Provide technical oversight, guidance and coordination for all the data management activities
Produce and track metrics as a tool to ensure that data management deliverables are on target.
Implement and promote the use of consistent, efficient and quality processes to meet timelines and deliverables.
Assist in the development and implementation of new TA clinical data standards
Ensure clear and timely communication with study team members to enable continuous improvements during the study
Proactively plan, assess workload, and prioritize activities to ensure study timelines are met
Ensure lessons learnt during the course of the study are documented and shared with other study teams to facilitate cross-study learning
Technical Skill Requirements
Demonstrated knowledge of clinical development process including knowledge and understanding of the principles of GCP
Demonstrated knowledge of data management processes and principles in area of responsibility.
Works independently, receives instruction primarily on unusual situations
Ability to organize tasks, time and priorities; ability to multi-task
Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally
Ability to work in ambiguous situations within teams to identify and articulate complex problems
Demonstrated knowledge of clinical development and regulatory submission processes and requirements.
Knowledge/proficiency/understanding of technologies to support data acquisition, computerization and data validation, computer systems life cycle technology
Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.
- Bachelor degree or equivalent in a natural/medical science, data management or related discipline.
Preferred Additional Experience
Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design
Previous experience within a data management role, understanding key processes and principles associated with role including CRF design, database set-up, edit check specification, DMPs and data cleaning activities
Knowledge of clinical trial database and its applications
Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.