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Sr Adjudication Project Lead

Company: Labcorp
Location: Durham
Posted on: October 12, 2021

Job Description:

Job Overview:

  • Manage all aspects of contracted adjudication start-up activities, including but not limited to:
    • 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
    • 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 leadership for Adjudication Services scope of assigned project(s). This includes, but is not limited to:
    • Providing oversight of Adjudication Services team activities pertaining to: deliverables, procedures, timelines, scope of work, budget, quality, productivity and profitability.
    • Assigning project work to supporting team members.
    • 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).
    • Attending internal and client team meetings.
    • 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 team members operate in accordance with the Adjudication Services Operational Plan in place on assigned project(s).
  • Manage execution of all aspects of the workflow pertaining to the processing of events for adjudication. This includes, but is not limited to, oversight of procedures for:
    • 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.
    • Contacting site personnel to obtain missing data and/or documents.
    • Escalating open events for issue resolution and closure, in accordance with relevant Escalation Plan.
    • Completing First Review QC Checklists or Second Review QC Checklists (as appropriate), assembling dossiers.
    • Conducting event reconciliation processes.
  • May directly perform QC of assembled dossiers, complete Second Review QC Checklists (as appropriate).
  • Manage implementation of adjudicator workflows. This includes, but is not limited to:
    • Implementation of adjudicator disagreement resolution processes.
    • Implementation of re-review and re-adjudication processes.
    • Processing of adjudicator requests for additional documentation.
    • Processing of adjudicator notifications of potential un-reported events.
  • Perform periodic and final project file reviews and ensure any findings are addressed.
  • Provide mentoring and/or training for less experienced Adjudication Services staff, as appropriate.
  • May participate in bid defenses or other presentations.
  • Work in accordance with the Standard Operating Procedure (SOP) system, including departmental Work Instructions (WIs).
  • Build and maintain good working relationships within the Adjudication Services department and across functional units.
  • Any other duties as assigned by management.

Education/Qualifications:

Minimum Required:

 

Level of education required (or experience level which may be substituted for level of education):

 

  • BS/BA Degree + 4 years relevant experience** (or 4 years adjudication experience*), including at least 2 years of team leadership experience***
  • MS/MA Degree + 3 years relevant experience (or 3 years adjudication experience), including at least 2 years of team leadership experience
  • RN + 2 years relevant experience (or 2 years adjudication experience), including at least 2 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 includes direct experience receiving and processing events for adjudication, working to collect event data and documents required for adjudication, working within adjudication event tracking systems.

 

**Relevant experience includes experience in the pharmaceutical, biotechnology, CRO or ARO industry in related areas, such as:  Clinical, Safety, Data Management.

Experience:

Minimum Required:

  • Ability to work independently in a high visibility team leadership capacity, with limited guidance.
  • Functions as a positive, engaging and motivating team player.
  • Ability to effectively balance multiple concurrent priorities in a fast-paced, complex setting.
  • Ability to effectively manage multiple internal and external customers competing concurrently for attention, services and resources.
  • Ability to present and share useful business information across departments and functions.
  • Ability to anticipate and identify problems and take appropriate action to correct.
  • Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.
  • Strong customer focus.
  • Strong written and verbal communication skills. Able to express complex ideas and concepts.
  • Strong presentation skills.
  • Knowledge of medical terminology.
  • Knowledge of hospital documentation practices.
  • Knowledge of Good Clinical Practice (GCP).
  • Good understanding of clinical data capture and data analysis practices.
  • High degree of accuracy with close attention to detail and ability to perform effective quality control.
  • Good familiarity with MS Office and Windows applications beneficial.

Keywords: Labcorp, Durham , Sr Adjudication Project Lead, Other , Durham, North Carolina

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