Job Overview :
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.- Conduct adjudication committee compilation processes.
This includes, but is not limited to :
Prepare event adjudication status reports and metrics.
Identification and screening of potential adjudicators.
Collection of signed Confidentiality Disclosure Agreements, CVs, completed Adjudicator Selection Questionnaires, signed Contracts from potential adjudicators.
Work in accordance with the Standard Operating Procedure (SOP) system, including departmental Work Instructions (WIs).-
Any other duties as assigned by management.
Build and maintain good working relationships within Adjudication Services department and across functional units.
Provide mentoring and quality control for less experienced Adjudication Services staff, as appropriate.
Education / Qualifications :
Level of education required (or experience level which may be substituted for level of education) :
B.Sc / M.Sc Life Sciences or equivalent With 1 to 3+ years of relevant experience
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.