上海招聘

Responsibilities:

Job Purpose:
v Manages the implementation of Medical Data Review, both processes and application of the tools by Clinical Scientists, by providing on-site training, development of best practices, and dedicated support. The person in this position optimizes the implementation of Medical Data Review by being an integral member of the MDR support network.

Main Responsibilities:
Provides training for medical data review tools
Owns the scheduled training program and ad hoc on-the-job training
Provides class room training/ one on one training as required
Assists with the access process to medical data review tools and provides guidance
Ensures tool users understand the data source(s) used for report generation, and assists with identification of questionable or discrepant content (includes some UAT)
Contributes to the co-ownership of the standard training materials for MDR tools (e.g. J-Review)
Co-develops applied job aids to support end users in use of the tools (e.g. tips and tricks sheets)
Maintains real-time training attendance records
Updates materials as systems undergo changes and alerts end users of changes as they occur

Provides support for medical data review
Acts as a main point of contact for Clinical Scientists with questions on Medical Data Review processes and documentation
Acts as the main point of contact for CDM report developers and Informatics (e.g. for specification set up and UAT)
Acts as a main point of contact for teams engaging with CROs for MDR of external data and champions the standards used with vendors
Provides guidance and actually develops ad hoc report objects to support ongoing MDR
Actively solicits input from users to identify areas requiring additional support
Delivers desk-side first level system support to end users, and understands when resolution requires escalation
Participates in meetings with tools’ owners to ensure end users requirements are met
Co-maintains an on-line PDC communication/document repository

Tracks system compliance
Monitors tracking reports for tool compliance and performance of reports
Reviews and provides the Informatics team with regular updates on status and metrics using standard/automated reports

Provides input into the global development of best practice for MDR
Promotes knowledge sharing across the Function and within Therapeutic Areas to improve MDR best practice
Provides input into the development of best practices of MDR Tool use and advises on the optimal use of standard tools and templates
Proactively gathers change requests for new/different report objects or changes in processes or standard templates
Supports the set up and maintenance of report objects built per study for medical data review
Encourages and champions standard report objects wherever possible (cross program/TA)
Proactively incorporates learning and recommendations from users
Contributes to activities for improving and maintaining the quality and effectiveness of tools within Clinical Science.
Participates in local and/or global initiatives that focus on the tools
Makes recommendations for improvements to Informatics and Developers
Partners with end users in proposing creation/revision of report objects
Uses Informatics, Developers of tools for information and knowledge based resource
Shares information across the MDR Specialist team and MDR Network
Maintains oversight of external available tools and functionality

System support management
Reviews and approves relevant System Development Life Cycle documents
Contributes to future upgrades and assessment for improvements, new releases, replacement software
Provides proactive support in terms of communication regarding updates and best practice

Requirements:

Basic Skills -
Working knowledge of relational databases, electronic data capture, SQL and SAS
Evidence of ability to collate and interpret clinical science information and general knowledge of the drug development process
· University/College degree
· Evidence of sound computer skills
· Evidence of being able to deliver effective training
· Demonstrable critical thinking and problem solving skills
· Evidence of excellent communication, interpersonal skills
· Evidence of ability to multi task, organize and prioritize assignments efficiently
· Evidence of ability to work independently as well as part of a team
· Demonstrable understanding of clinical trials conduct preferred
· Preferably shows a working knowledge and experience of a data review tool

More Information related to This Position

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