Adjudication Project Manager leading and overseeing adjudication processes and teams for clinical trials in Canada. Managing client relations and ensuring compliance with project budgets and timelines.
Responsibilities
Oversee conduct by project lead of all aspects of contracted adjudication start-up activities for assigned project(s)
Compiling adjudication committee membership, developing the Adjudication Committee Charter, developing the Site Manual, developing the Adjudication Services Operational Plan, Developing workflows and data capture forms and developing tracking tools and reports.
Developing and delivering project-specific training to stakeholder groups (e.g., Adjudication Services staff, project team members, client staff, adjudicators, sites).
Provide ongoing functional operational oversight of the project lead who is directly responsible for the Adjudication Services scope for assigned project(s).
Providing oversight of Adjudication Services team activities pertaining to: deliverables, procedures, timelines, scope of work, budget, quality, productivity and profitability.
Monitoring workflow and project status to ensure all deliverables and deadlines are met; making adjustments and escalating potential issues to relevant individuals, as appropriate.
Managing any vendors contracted to support Adjudication Services.
Reviewing and distributing event adjudication status reports and metrics to relevant stakeholders.
Providing input into client invoicing and vendor payment.
Serving as central point of contact and communications, representing Adjudication Services on assigned project(s).
Interfacing regularly with customers, both internal and external (including adjudicators).
Conducting and minuting Adjudication Services team meetings.
Coordinating, conducting and minuting relevant sessions of adjudication meetings.
Ensuring compliance with project budget, actively identifying out of scope work and escalating potential scope changes to appropriate individuals.
Ensure that project leads and team members operate in accordance with the Adjudication Services Operational Plan in place on assigned project(s).
Oversee execution of all aspects of the workflow pertaining to the processing of events for adjudication on assigned project(s).
Maintaining event tracking systems.
Event case processing: intake and triage, event linking, event de-activation, tracking, data entry, document processing (e.g. redaction of specified content), review of incoming event information for completeness and accuracy, content review, identification of missing required data and/or documents, generation of queries, Query review and closure/re-issue.
Ability to direct, manage, and coordinate the day-to-day efforts of multiple levels of staff.
Ability to work independently in a high visibility team leadership capacity, which includes effectively balancing multiple concurrent priorities in a fast-paced, complex setting.
Requirements
BS/BA Degree + 6 years relevant experience (or 6 years adjudication experience*), including at least 4 years of team leadership experience
MS/MA Degree + 5 years relevant experience (or 5 years adjudication experience), including at least 4 years of team leadership experience
RN + 4 years relevant experience (or 4 years adjudication experience), including at least 4 years of team leadership experience
Degree preferred (but not necessary) to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
Adjudication experience within a CRO or Pharma environment
Benefits
Frequent travel to clients/ site locations with occasional travel both domestic and international.
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