Job Overview:
Responsible for providing coordination and support of projects operated by the Adjudication Services department, to ensure smooth delivery and achievement of the objective that all adjudication events are processed and submitted for adjudication within the agreed upon procedures, timelines, budget, and quality standards. This post holder is responsible for providing this service for client projects, either as a support function to the client project groups or as standalone business. This post holder operates under limited guidance by Adjudication Services project leadership and/or Adjudication Services management. This post holder is typically assigned to a number of concurrent projects which are typically moderate-to-high with respect to scale, scope, and complexity. It is the responsibility of the post holder to provide all clients, both internal and external with the appropriate quality of service in a safe and cost-effective manner.
Summary of Responsibilities:
- Operate in accordance with the Adjudication Services Operational Plan in place on assigned project(s).
- Perform processing of adjudication events. This includes but is not limited to:
- 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.
- Coordinate 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.
- Prepare event adjudication status reports and metrics.
- Conduct adjudication committee compilation processes. This includes but is not limited to:
- Identification and screening of potential adjudicators.
- Collection of signed Confidentiality Disclosure Agreements, CVs, completed Adjudicator Selection Questionnaires, signed Contracts from potential adjudicators.
- Provide mentoring and quality control for less experienced Adjudication Services staff, as appropriate.
- 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.
Qualifications (Minimum Required):
- Level of education required (or experience level which may be substituted for level of education):
- Non-Degree + 6 years relevant experience** (or 6 years adjudication experience*).
- Associate degree + 4 years relevant experience (or 4 years adjudication experience).
- BS/BA Degree + 2 years relevant experience (or 2 years adjudication experience).
- RN + 0 years relevant experience (0 years 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.
- Speaking: English and local language.
- Writing/Reading: English and local language.
- *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):
- High degree of accuracy with close attention to detail.
- Functions as a strong team player.
- Ability to work efficiently with limited guidance.
- Ability to effectively balance multiple concurrent priorities.
- Ability to present and share useful business information across departments and functions.
- Ability to anticipate and identify problems and take appropriate action to correct.
- Strong written and verbal communication skills. Knowledge of medical terminology.
- Knowledge of hospital documentation practices.
- Knowledge of Good Clinical Practice (GCP).
- Accurate math and spelling skills preferably with an aptitude for handling and proof-reading numerical data.
- Good keyboard skills with knowledge of MS Office and Windows applications beneficial.
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