Job Overview :
Participate in all aspects of adjudication start-up activities, including but not limited to : o Compiling adjudication committee membership o Providing review and input into the Adjudication Committee Charter o Developing the Site Manual o Developing the Adjudication Services Operational Plan o Providing review and input into workflows and data capture forms o Providing review and input into development of tracking tools and reports o Developing and delivering project-
specific training to limited stakeholder groups (e.g. Adjudication Services staff, project team members, 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 suppolting 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.
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 : o Implementation of adjudicator disagreement resolution processes.
o Implementation of re-review and re-adjudication processes. o 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 :
Level of education required (or experience level which may be substituted for level of education) :
Non-Degree + 8 years relevant experience*
or 8 years adjudication experience*)
Associates Degree + 6 years relevant experience (or 6 years adjudication experience)
BS / BA Degree + 3 years relevant experience (or 3 years adjudication experience)
RN + 1 year relevant experience (or I year adjudication 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.
Ability to work independently in a team leadership capacity, with moderate guidance.
Functions as a positive, engaging and motivating team player.
Ability to effectively balance multiple concurrent priorities.
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.
Good customer focus.
Strong written and verbal communication skills. Able to express complex ideas and concepts.
Good presentation skills.
Knowledge of medical terminology.
Knowledge of hospital documentation practices.
Knowledge of Good Clinical Practice (GCP).
Basic 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.