ROLE RESPONSIBILITIES

General:

· Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.

· Assist to set up and test study level Risk-based Monitoring system.
· Execute communication plans & methods to meet study requirement.

· Assist to resolve conflicts, influence and communicate with key stakeholders and customers.

System setup Functions:

· Set up and test RBM system at study level to ensure system quality.

· Define key risk indicators (KRIs) in study system, and ensure consistency between the standard level and the study level.

· Ensure RBM system align with the protocol and adhere to ICH GCP, SOPs, corporate standards and regulatory requirements.


Data review Functions:

· Implement and maintain Quality Control related documentations for RBM related activities to ensure data completeness and accuracy.

· Assist to central monitoring activities including review system outputs, signal and action management.

BASIC QUALIFICATIONS:

· Bachelor's degree in a scientific or business related discipline required.

· 0-2 years of relevant working experience.

· Works independently, receives instruction primarily on unusual situations.

· Ability to organize tasks, time and priorities; ability to multi-task.

· Ability to communicate with internal & external stakeholders, locally and globally.

PREFERRED QUALIFICATIONS:

· Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design.

· Technical expertise in supporting clinical trials database development, data management, site monitoring, etc.

· 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.

· Familiar with the processes associated with clinical study management, data management, and regulatory operations.

· Knowledge of clinical trial database and its applications.

· Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.).

· Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

To apply please visit our website www.pfizercareers.com and search job Associate Central Monitor, Data Surveillance, Clinical Data Sciences id 4923613.