Global Trial Manager (Taiwan Home-Based)

As a Global Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Job Purpose

Contributes, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team.

What you will be doing:

Contributes to all operational trial deliverables, under the oversight of the (Associate) Global Trial Director, according to timelines, budget, operational procedures,  quality /compliance and performance standards. Assigned responsibilities can include but are not limited to :

•   Development of specific sections of the protocol and related documents;

•   Development of study tools, guidelines and training materials;

•   Organization and logistics of various trial advisory committees  (e.g. Data

Monitoring Committee, Steering Committee);

•   Ensuring trial information/results are reported within relevant trial

repositories and tracking systems (e.g. trial results registries);

•   Supporting forecast and management of drug supply for sponsor and

comparator drug products in collaboration with internal stakeholders;

•   Contributing to development of clinical outsourcing specifications  (as

required) to facilitate bid process  and selection of Contract Research

Organizations (CROs); managing interface with CROs in cooperation  with

outsourcing management and line functions; ensuring vendors meet

quality standards; contributing to the development/amendment of

vendor contracts;

•   Contributing to the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan in collaboration with the trial data manager, trial statistician, statistical programmer and clinical development representative;

•   Implementing issue resolution plans;

•   Acting as point of contact for all site-related issues and procedural questions;

•   Managing interactions with relevant line functions including data management, drug supply management, clinical development and Sponsor Country Pharma Organizations;

•   Ensuring proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.

2.   Resource Management:

•   Supports the Global Trial Director with the development, management

and tracking of the trial level life cycle budget incl forecast, and annual

cost targets.

3.   Core member of the global cross-functional Clinical Trial Team (CTT); participate and report study progress and issues/resolution plan at the CTT meeting; write CTT meeting minutes. Organize and chair trial sub teams within the scope  of his/her delegated responsibilities. Extended member of the Global Clinical Team (GCT).

4.   As member of the CTT, contribute to defining the Data Review Plan; participate

in data review as specified in the Data Review Plan.

5.   May contribute to talent development through active participation in onboarding and training activities. May participate in GDO Trial Management initiatives and working groups.

6.   Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s) and within clinical program(s) and franchise, including sharing lessons learned.

You are:

• 2-4 years of experience in clinical development. Involvement in cross-functional, multicultural and international clinical trials; demonstrated capabilities in supporting operational aspects of clinical trial related activities.

• Excellent communication, organization and tracking skills.

• Proven ability to work either independently or in a team setting, to meet goals by managing compliance, budget and timelines.

• Proven networking skills and ability to share knowledge and experience amongst

colleagues.

• Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process.

• Basic knowledge of appropriate therapeutic area.

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.