Study Management, Adjudication Lead

ROLE SUMMARY:

• The Adjudication Lead is the primary person accountable for program and study adjudication deliverables
  
• The Adjudication Lead has responsibility for managing adjudication activities for one or more studies or programs from study start up through database release
  
• The Adjudication Lead provides quality oversight to the Adjudication Vendor and their associated adjudication deliverables
  
• The Adjudication Lead drives 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 Lead will provide leadership to the teams in the setting of adjudication delivery milestones partnering with cross functional colleagues and/or Adjudication Vendor
  
• The Adjudication Lead is a critical member of the Study Team and will represent the adjudication vendor(s) on matters of adjudication
  
• The Adjudication Lead works with functional lines and directly with the adjudication vendor to resolve or triage adjudication issues
  
• The Adjudication Lead is the point person for adjudication vendor contracting and monitors contracts for out of scope activities and budget spend/invoices for assigned vendors
  

Responsible for oversight of all adjudication activities internally and at the adjudication vendor

• Provides Sourcing Strategy, input into Requests for Proposals, and for the selection of the adjudication vendor
  
• Contributes to study/protocol training & investigator meetings
  
• Responsible for adjudication vendor contracts and monitoring for out of scope activities and budget spend/invoices for assigned vendors
  
• Accountable for the delivery of adjudication activities against approved plans
  
• Leads inspection readiness activities related to adjudication
  

Adjudication Oversight

• Approves adjudication plans and documents
  
• Reviews metrics and case status tracking reports in partnership with cross functional colleagues
  
• Supports study/program level submission readiness
  
• Participates in vendor UAT and system set-up requirements review and approval
  

Study Team Interface

• Leads and oversees all elements of adjudication activities both internally and at the adjudication vendor to ensure delivery & compliance with all applicable Standard Operating Procedures and Quality Standards
  
• Works proactively with adjudication vendor and data management functions to ensure alignment on data flow and timely delivery
  
• Shares and escalates plan deviations to Clinical Study Team Lead (and study team) and drives/oversees mitigations
  
• Review adjudication vendor budget and WO as per Clinical Trial Budget.
  
• Provides ongoing assessment of subject enrollment to adjudication vendor to inform accurate resource planning of adjudication case processing
  
• Attend and contribute to adjudication vendor meetings
  

Subject Matter Expertise

• The Adjudication Lead will be responsible for the operational oversight of the adjudication vendor to include but is not limited to standards, continuous improvement, issue escalation/resolution, inspection readiness/quality assurance, performance feedback, review of metrics
  

• The Adjudication Lead will champion the implementation and use of harmonized, consistent processes, and excellence in adjudication deliverables related to cost-effective, timely, and high-quality clinical trial data according to agreed global goals
  

BASIC QUALIFICATIONS:

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.
  

Prior Experience

• Demonstrated study management/leadership experience
  
• Demonstrated oversight of CROs/vendors
  

PREFERRED QUALIFICATIONS:

• 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)
  

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Travel may be required, including Investigator Meetings, Vendor Kick Off Meetings and Vendor Re-set Meetings.

Adjudication Lead may be required to work outside of core business hours to support global trials or initiatives.

#LI-PFE

#LI-REMOTE

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