上海招聘

Responsibilities:

Primary Responsibilities and Accountabilities:
1) Operational Support: Ensure Consistency of the implementation and interpretation of local PDGA Quality Standards by Risk Analysis and Knowledge Sharing.

l Provides timely and accurate guidance to local PDGA staff on the effective implementation of ICH.GCP, RO/GNE SOPs, regulations and guidelines.
l Communicates changes to regulatory or local requirements or new PD/PDG/local PDGA procedures and policies to all staffs members.
l Conducts and reports Process and Training Reviews and oversight activities.
l Assists local PDGA Line Management, as requested, by proposing action plans to improve clinical trial processes.
l Recommends and implements, as appropriate, process improvements to facilitate the achievement of local PDGA quality standards and improve efficiencies.
l Interacts with other departments within PD, as required, to encourage knowledge sharing and input on the development of global and local SOPs/guidance and quality standards, where required.
l Provides input and expertise to local PDGA through participation as a proactive member of the global Affiliate Process and Training network and liaises appropriately with the local PDGA Affiliate Process & Training Manager and/or Regional Affiliate and Process Training (RAPT) Head as applicable, in an effort to ensure consistency, efficiency and communication across local PDGA and/or across all countries and regions as applicable.
l Shares best practice and escalate issues to the local PDGA Affiliate Process & Training Manager and/or Regional Affiliate and Process Training (RAPT) Head or Subject Matter Experts (SME) as appropriate.
l Supports the Implementation of global, regional and local initiatives.

2) Process Management: Ensures local PDGA Processes, Supporting Documents and Forms are in alignment with Global and local Roche/GNE SOPs and Regulatory requirementsand are consistently applied, implemented and documented.

l Recommends, reviews, revises, writes, and maintains, as required, new Local SOPs/guidance to compliment Roche-GNE SOPs, local regulatory and business requirements based on gaps identified during regulatory inspections and internal reviews and audits. Develop and maintain process tools, such as checklists.
l Ensures continuous improvements in alignment with the business needs and quality standards.
l Participates as a global SME on Global Process development teams, if applicable.

3) Training: Supports the delivery of effective training programs for local PDGA Staff to ensure the integrity of the conduct of Roche-GNE Clinical Trials in compliance with global and local requirements.

l Ensures the local training curriculum is aligned with the PDGA Training Grid, TPS, PDQ and local needs.
l Assists local PDGA staff members in maintaining and/or improving quality standards through the ongoing development of new training modules based on identified training gaps.
l Prepares and organize orientation training program to local PDGA new staff.
l In conjunction with global training partners, provide input into training programs to be delivered to local PDGA staff, as applicable. Where required, participate as a global/regional trainer for the implementation of the training program.
l Ensures training interventions are documented within a learning management system.

4) Quality and Risk Management.
l Provides Audit/Inspection support to local PDGA team, as needed.
l Ensures CAPAs are in alignment with local and global SOPs and regulatory requirements.
l Ensures best practices and experiences from audits and inspections are shared across the local PDGA, as required.
l Collaborates with local PDGA staff in the review and assessment of Quality Risk Management (QRM) reports for compliance related questions and mitigation plans.
l Ensures the local PDGA is Inspection Ready.
l Promotes the identification of risks affecting study conduct in the country and the development of plans to mitigate and/or address issues.

Requirements:

Qualification and Experience:
· Education/Qualifications: At least bachelor degree or equivalent in a biomedical/pharmacy/nursing/healthcare discipline.
· Relevant working experience: 3 years or above clinical research experiences in a global pharmaceutical company/CRO. Experience in GLP/GMP or Clinical Quality Assurance would also be considered and is a plus.
· Language: Good command of written and verbal English, Mandarin.
· Computer skill: Knowledge of general Microsoft Application.
· Other skills and/or competence: Good analytical, communication, interpersonal, organizational planning and presentation skills. Demonstrates ability to seek innovative solutions. Self-motivated and result driven.
Others: Local/International Travel, Outside Office Hours, may be required.

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