What are the responsibilities and job description for the Associate Central Monitor, Risk Based Monitoring, DMM position at Pfizer?
The Associate Central Monitor is supporting the completeness, quality and integrity of the subject data in the clinical trial database under Risk Based Monitoring (RBM) model. The areas of activity include but are not limited to: developing Risk-Based Monitoring analytics system for applicable studies, ensuring key risk indicators (KRIs) properly defined and set up in the system to support the study. The Associate CM supports risk based monitoring activities and complies with regulations, applicable Standard Operating Procedures (SOPs) and Processes at all times and is familiar with supported systems (RBM system, etc.).
How You Will Achieve It
General:
- Assist the manager 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 analytics system
- Help 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 analytics 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 analytics 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 central monitoring activities including review system outputs, signal and action management.
Qualifications
Must-Have
- Bachelor’s degree or above of equivalent experience in a scientific or business related discipline required.
- 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
Nice-to-Have
- 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 requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
