Advisor- Compliance Process, Training & Systems (CPTS), Country Clinical Operations (Hong Kong & China)

Job description

·  Job facts

Position Purpose

The role of CPTS advisor is to implement Hong Kong and China CPTS strategy in line with the global CPTS direction and to provide GCP expertise to country clinical operations team in order to ensure delivery of fit for purpose processes, system and training, enabling efficient and GCP compliant delivery.

Main Accountabilities & Responsibilities

·Make decision around CPTS deliverables and take ownership to drive impactful results

·Deliver CPTS tactics to enable clinical operations is inspection ready

·Embed a continuous improvement culture in clinical operations

·Facilitate cross-country alignment, information sharing and best practices

·Build influential partnership with key internal, external and regional stakeholders to ensure business needs are met

·Identify risk/issues and ensure effective management by accountable functions

·Anticipate the need of country clinical operations and implement changes in strategy

·Provide GCP, process, system and training expertise and take lead for continuous improvement initiatives

·Escalate local needs that may require global solutions

·Develop and maintain local CPTS business process

·Support local audit and inspections and ensure CAPA are effectively implemented

·Oversight of FSP partnership

·Coordinate with stakeholders to ensure staff are effectively trained and support per job scope and requirement

Requirements

·Bachelor degree (or equivalent) in a science discipline

·Experience working in clinical operations management in drug development setting

·Effective leadership, influencing, communication skills and teamwork

·Expert knowledge of ICH GCP and local regulatory requirements

·Good language skills in English and Chinese (Mandarin & Cantonese)

Roche is an equal opportunity employer.
Research & Development, Research & Development > Drug Safety

·  Who we are

At Roche, 98,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer.