Job Summary

The incumbent will be a highly competent, self-motivated individual who can support clinical research studies in all phases. The individual should possess good judgment with well-developed critical thinking and super attention to detail skills.

Required to perform tasks for projects according to timelines for the designated workflows, which may have multiple studies overlapping in the timeframe. Primary responsibility for clinical review to assure data completeness, consistency, logic and medical accuracy, patient safety and protocol compliance. Have general knowledge of clinical review of case content that includes source documents, such as procedure reports, hospitalization summaries, narratives, CIOMS, and AE coding. Provide clinical support in project meetings; Support study close out activities. Assists with the clinical aspects of charter development; be aware of the MedDRA preferred terms listings for the protocol's indication.

Job Description

Responsibilities

Adjudication / Endpoint Workstream Planning and Execution

• Ensures optimal program productivity and efficiencies.
• Become a Subject Matter Expert (SME) with the process currently in use; be able to describe to study teams and other key departments how their study will interact with the adjudication vendor;
• Describe the expectation and importance of adjudication between the vendor to the CRO;
• Become an active “extended team member” to multiple studies at the same time; Being extremely organized to discuss with studies at different timepoints.
• Working with senior management, biostats and safety physicians when prioritization of deliverables are requested.
• Preparing meaningful metrics and reports for senior leadership, as well as study teams to make them aware of urgency and/ or details; Provide updates to internal teams; reporting on critical project status, risks, escalations and achievements.
• Triage, resolve or escalate study issues to the Study Manager, Global Team Lead and CSPV.
• Read, understand and adhere to Daiichi Sankyo GSOPs related to Adjudication and Independent Review Committees.
• Contributes to Adjudication Operations team by exploring new opportunities to add value and repeat the key processes consistently.

Adjudication Committee

• Provide clinical administrative support to the committee. This may include preparing meeting agendas, and training materials to be used for new members.
• Collect documents from the members, related to general regulatory processes, i.e. CVs, financial disclosures, professional journals, etc.
• May review and oversee AC members payments requests.

Adjudication Documentation

• Provide oversight of the creation and filing of Charters, Plans, Site Manuals, Quick Reference guides; Provide insight to which documents are translated for global use, Reconcile the Adjudication documents in the TMF by compound and protocol. Identify and resolve issues with the reconciliation.
• Support analysis of study site ILD adjudication metrics reports to identify potential areas of concern, trends, missing eDC pages, issues with image uploading; bring to the attention of the Study Team / CRO; offer solutions
• Track study site start-up recruitment, enrollment, expansion into additional countries and use of replacement sites; be aware of study’s milestones and timelines.
• Participate in ILD Adjudication training at Investigator Meetings, Site Initiations, global CRA trainings; make recommendations for better communication with sites and coordinators;
• Analyze reports from the electronic adjudication system, searching for outstanding query ranges; discrepancies in dates or adverse event terms.

Qualifications

Education Qualifications

• Master's degree with 3+ years of relevant experience or Bachelor's degree with 5+ years relevant experience is required

Experience Qualifications

• Knowledge of ICH/GCP and regulatory guidelines/directives preferred
• Knowledge of Adjudication process and working with adjudication committees and/or Independent Review Committees preferred

Travel Requirements
Ability to travel up to 10% of the time. Position that may require occasional travel (global).