Sr. Associate Central Monitor, Risk Based Monitoring, DMM
ROLE SUMMARY**
The Sr. Central Monitor is responsible for ensuring the completeness, quality and integrity of clinical trial data in Pfizer's Risk Based Monitoring (RBM) ecosystem. The areas of activity include but are not limited to: developing Risk-Based Monitoring system for applicable studies, ensuring key risk indicators (KRIs) are properly defined and configured to support the study, processing and reviewing study data for risk signals and action management, and following up through issue resolution.
The Sr. Central Monitor ensures risk-based monitoring activities comply with regulations, applicable Standard Operating Procedures (SOPs) and processes at all times. S/he will be the translator between the technical team and study team, delivering end to end support of clinical trials risk-based approaches.
**ROLE RESPONSIBILITIES**
General:
+ Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
+ Use clinical trial process experience to translate study risks into technical specifications that will support monitoring in a risk-based approach.
+ Review RBQM system output to tell a compelling story of operational and data risk for study team action.
+ Plan and execute communication plans & methods to ensure customer satisfaction and enable improvements to be implemented during the course of a study.
+ Able to resolve conflicts, influence and communicate with key stakeholders and customers.
+ Implement quality oversight/control steps implemented in the central monitor activities.
+ Use project management skills to independently oversee the on-time execution of study deliverables.
System setup Functions:
+ Review protocols to ensure the set-up, review and reporting requirements can be met and are standardized.
+ Provide technical oversight, guidance and coordination for all the central monitor activities.
+ Define RBM system requirements at the study level to ensure quality and study objectives are supported.
+ Define appropriate study-specific key risk indicators (KRIs).
+ Ensure RBM system align with the protocol and adhere to ICH GCP, SOPs, corporate standards and regulatory requirements.
Data review Functions:
+ Work with Study Team to define the issue resolution for the reviewing findings as signal and action.
+ Develop, implement and maintain Quality Control related documentation for RBM related activities to ensure data completeness and accuracy.
+ Perform central monitoring activities including review system outputs, propose suggestion for signal and action management, and follow up with study team for the action resolution.
+ Work with Clinical Data Scientist to ensure all signal and actions are properly mitigated and RBM systems properly released.
+ Ensure lessons learnt during the course of the study are documented and shared with other central monitors/ study teams to facilitate cross-study learning.
**BASIC QUALIFICATIONS:**
+ Bachelor's degree or above or equivalent experience in a scientific or business related discipline required.
+ 3 - 5 years working experience in the clinical development fields.
+ Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design.
+ Previous experience within clinical trials, understanding key processes and principles associated with clinical database set-up, external data flow, and site monitoring activities.
+ Knowledge of clinical trial databases and all clinical trial data sources.
+ Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.).
Technical Skill Requirements:
+ Technical expertise and business experience in supporting clinical trials such as obtained through database development, data management, site monitoring, etc.
+ Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations.
+ Project management skills and technical capabilities as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
+ Self-motivated with an ability to organize tasks, time and priorities; ability to multi-task.
+ Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally.
+ Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.
**PHYSICAL/MENTAL REQUIREMENTS**
+ Primarily an office-based position involving sitting, walking to meetings, making presentations, etc.
**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.
Work Location Assignment: Remote/Hybrid.
**/#LI-PFE**
The annual base salary for this position ranges from $78,000.00 to $130,000.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments.Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.
Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
**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. This position requires permanent work authorization in the United States.
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