The Adjudication Process and Vendor Lead is a strategic global role critical to operationalizing adjudication, including the development of the Adjudication Lead role and associated processes.
The Adjudication Process and Vendor Lead will manage process performance and compliance, drive process improvements, ensure training/knowledge gaps are closed, and drive strategy for executing adjudication for study teams. The Adjudication Lead provides quality oversight to the Adjudication Vendor and their associated adjudication deliverables.
The Adjudication Process and Vendor Lead coordinates adjudication activities of a clinical trial from the Sourcing Strategy and Study Specification development for Requests for Proposals, Study start-up through Database release and inspection readiness to ensure timely delivery of quality adjudication data.
The Adjudication Process and Vendor Lead monitors adjudication vendor contracts for out-of-scope activities, approves Purchase Orders for Adjudication vendors and monitors budget spend for associated invoices. ROLE RESPONSIBILITIES
- Partner with the Lead Clinical Operations Process and Standards and Adjudication Leads on the roll-out and implementation of new processes, guidance documents, assessing learning gaps and opportunities within the organization.
- Is a Subject Matter Expert (SME) on assigned processes/SOPs and associated systems for stakeholders across the organization as well as to the relevant vendors.
- Identify quality goals, metrics, and standards for the adjudication organization in partnership with those above, supporting a culture of high quality by creating, updating, and improving tools used by Adjudication Leads to facilitate consistency and quality Adjudication metrics.
- Support strategic sourcing, vendor selection, assessment, onboarding, and monitor performance of Adjudication vendors in clinical trials.
- Lead a cross-functional support team to ensure vendor risk management, vendor issues management, and general GCP guidance are maintained for all relevant vendors within this service categories.
- Monitor and support compliance with sourcing and contracting.
- Ensure appropriate communication and oversight of Adjudication vendors.
- Support audit/inspections/litigation readiness and CAPA responses.
- Provide guidance and expertise to teams for required vendor onboarding and engagement activities.
- Act as functional line in QMS09 vendor assessments and onboarding.
- Define and assign curriculum to vendor resources; ensure systems access and compliance for vendor resources.
- Serve as core member of governance structure.
- Assist Contracting Organization with MSA and rate card negotiations.
- Monitor trends, SQEs, metrics related to time/ quality/ cost.
- Track volume and spend across preferred vendors.
- Maintain a minable database of issue escalation, CAPAs, remediation plans, and monitoring systemic deficiencies.
- This individual may be expected to work at the study level in the adjudication space as Adjudication Lead.
Training and Education
- 7+ years of clinical research experience and/or study management experience.
- Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
- A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology and experience with adjudication activities. In general, candidates for this job would hold the following levels of education/experience: BS/BSc/MS/MSc; a nursing diploma or associate degree in nursing may also be considered with extensive clinical trial experience.
- Demonstrated study management/leadership experience
- Demonstrated oversight of CROs/vendors
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Understands how to work with and drive vendor performance to meet deliverables
- Ability to interpret study level data & translate and identify risks
- Ability to proactively identify & mitigate risks around adjudication in study execution
- Country-level cultural awareness and strong interpersonal skills
- Keen problem-solving skills
- Excellent communication skills, both written and verbal. Must be fluent in English.
- Detail-oriented & possesses technical expertise (e.g., spreadsheets, metrics & data flow management).
Travel may be required, including Investigator Meetings, Vendor Kick Off Meetings and Vendor Re-set Meetings.
May be required to work outside of core business hours to support global trials or initiatives.
Work Location Assignment:Remote
As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Central Monitor is a highly technical study team member responsible for programmatically applying statistical tests to identify areas of risk in operational and clinical trial data in Pfizer's Risk Based Monitoring (RBM) model.
Activities typically include developing the Risk-Based Monitoring system (i.e. CluePoints) for applicable studies, ensuring key risk indicators (KRIs) and data quality assessment (DQA) properly defined and set up in the system to support the study, processing and reviewing study data in the system for the signal and action management, and follow up for the issue resolution. How You Will Achieve It
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.
- Set up and test RBM- Central Monitoring 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 system alignment with the protocol and adherence to ICH GCP, SOPs, corporate standards and regulatory requirements.
Data review Functions:
- Work with Study Team to define the issue resolution for the review of findings as signals and actions.
- 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 suggestions for signal and action management, and follow up with study team for the action resolutions.
- Work with Clinical Data Scientist (CDS) to ensure all signals 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.
- Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
- Provide technical expertise to set up and test study level Risk-based Monitoring system.
- Review study level system outputs to process for the signal and action management.
- 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 cross-functionally with key stakeholders and customers.
- Bachelor's Degree in a scientific or business related discipline.
- 3+ years' professional experience, ideally in data management/programming or other technical area.
- Demonstrated knowledge of clinical development including knowledge and understanding of the principles of GCP, particularly in relation to risk-based monitoring.
- Understanding of clinical trials.
- Awareness of relevant data standards, e.g. CDISC, CDASH, SDTM.
- Experience with or ability to learn programming in a clinical trial environment, e.g. SAS code, SQL query, R, Python, to extract and analyze operational and clinical trial data from various information systems.
- Ability to critically analyze, interpret, and summarize statistical output from risk-based quality management software, e.g. CluePoints
- Ability to manage tasks, time and priorities.
- Demonstrated effective verbal and written communication skills, including the ability to communicate in a remote team environment and adapt communications to audience.
- Master's degree.
- Relevant pharmaceutical industry experience.
- Experience with or ability to learn data visualization techniques, e.g. Spotfire, JReview, Tableau, PowerBI.
- Proficient experience using commercial clinical data management systems and/or EDC products.
Relocation assistance may be available based on business needs and/or eligibility.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.