Jade (Xiu) Mao

Work History

Global Project Director

Tigermed Australia

05.2024 - Current

Oversees multiple of functional roles as project director or project manager for Start-up project manager, Clinical Team Lead to ensure all initial or amended trial information is submitted, approved and filed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trials.
Coordinate with clients with clinical and project management activities within timelines, quality and scope.
Liaises with managers to resolve functional resource and performance issues. Disseminates and agrees forecasted activities/FTE to all key team members.
Reporting to higher management team of Company for the progress of the studies regularly
Conduct the scope and contract management and review the financial metrics reports. Coordinate out-out-scope change approval and master service contract amendment change.
Support proposals for new and repeated business opportunities
Guide and instruct direct reports as line manager
Support optimization of SOPs and systems working as process owner and subject matter expert.

Associate Global Project Director

Tigermed Australia

06.2022 - 04.2024

Oversees multiple of functional roles as global project director or global manager for Start-up project manager and clinical operation team to ensure all initial or amended trial information is submitted, approved and filed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trials.
Coordinate with clients with clinical and project management activities within timelines, quality and scope.
Plans, oversees and conducts initial and ongoing project-specific training for the study team on clinical project specifics.
Analyzes data in metrics reports related to sites activation, monitoring, data retrieval and close out to identify issues and risks to clinical deliverables; develops contingency and mitigation plans to minimize risks; communicates risks & mitigation strategies to global project manager and functional Manager.
Liaises with managers to resolve functional resource and performance issues. Disseminates and agrees forecasted activities/FTE to all key team members.
Managing and overseeing the local vendors such as SMO, recruiting vendor, facility & equipment and translation vendor operationally and financially.
Reporting to higher management team of Company for the progress of the studies regularly
Conduct the scope and contract management and review the financial metrics reports. Coordinate out-out-scope change approval and master service contract amendment change.
Support and present in Biding Defence meetings

Associate Global Project Director

Tigermed Hangzhou

05.2021 - 05.2022

Lead and look after GPM’s work and performance
Oversees multiple of functional roles as regional project manager for Start-up project manager, Clinical Team Lead to ensure all initial or amended trial information is submitted, approved and filed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trials
Coordinate with clients with clinical and project management activities within timelines, quality and scope
Plans, oversees and conducts initial and ongoing project-specific training for the study team on clinical project specifics
Analyzes data in metrics reports related to sites activation, monitoring, data retrieval and close out to identify issues and risks to clinical deliverables; develops contingency and mitigation plans to minimize risks; communicates risks & mitigation strategies to global project manager and functional Manager
Liaises with managers to resolve functional resource and performance issues
Disseminates and agrees forecasted activities/FTE to all key team members
Managing and overseeing the local vendors such as SMO, recruiting vendor, facility & equipment and translation vendor operationally and financially
Reporting to higher management team of Company for the progress of the studies regularly
Conduct the scope and contract management and review the financial metrics reports
Coordinate out-out-scope change approval and master service contract amendment change
Support and present in Biding Defense meetings

Senior Project Manager

Syneos Health

1 1 - 04.2021

Oversees multiple of functional roles as regional project manager for Start-up project manager, Clinical Team Lead to ensure all initial or amended trial information is submitted, approved and filed in accordance with the trial protocol, local regulations, ICH-GCP
Coordinate with clients with clinical and project management activities within timelines, quality and scope
Analyzes data in metrics reports related to sites activation, monitoring, data retrieval and close out to identify issues and risks to clinical deliverables; develops contingency and mitigation plans to minimize risks; communicates risks & mitigation strategies to global project manager and functional Manager
Liaises with managers to resolve functional resource and performance issues
Disseminates and agrees forecasted activities/FTE to all key team members
Managing and overseeing the local vendors such as SMO, recruiting vendor, facility & equipment and translation vendor operationally and financially
Conduct the scope and contract management and review the financial metrics reports
Coordinate out-out-scope change approval and master service contract amendment change
Support and present in Biding Defense meetings
Support as buddy within project management team for new team members

Senior Project Manager

Covance Pharmaceutical Research & Development (Beijing) Co. Ltd

07.2018 - 08.2020

Oversees multiple of functional roles for Start-up project manager, Clinical Team Lead, Quality Control Lead, Quality Assurance lead, Regulatory Affairs Lead, Vendor Manager, Medical lead, contract manager to ensure all initial or amended trial information is submitted, approved and filed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trials
Coordinate with clients with clinical and project management activities within timelines, quality and scope
Coordinate Clinical activities on local multi-center trials
Liaise with US project Lead for a China client in one study involving countries as US and China
Analyzes data in metrics reports related to sites activation, monitoring, data retrieval and close out to identify issues and risks to clinical deliverables; develops contingency and mitigation plans to minimize risks; communicates risks & mitigation strategies to Project Director, Functional Manager, and other senior staff as needed
Liaises with managers to resolve functional resource and performance issues
Coordinate and oversee with regular tasks for Quality assurance, Quality control, Safety department, Regulatory Affairs department, Translation vendor, Vendor Management, Drug&Facility Vendor within scope of contract
Managing and overseeing the local vendors such as central labs, SMO, facility & equipment and translation vendor operationally and financially
Conduct the scope and contract management and review the financial metrics reports
Coordinate out-out-scope change approval and master service contract amendment change
Support and present in Biding Defense meetings

Project Manager

Covance Pharmaceutical Research & Development (Beijing) Co. Ltd

07.2017 - 06.2018

Oversees multiple of functional roles for Start-up project manager, Clinical Team Lead, Start-up Lead, Quality Control Lead, Quality Assurance lead, Regulatory Affairs to ensure all initial or amended trial information is submitted, approved and filed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trial
Coordinate with clients with clinical and project management activities within timelines, quality and scope
Plans, oversees and conducts initial and ongoing training for the study team on clinical project specifics
Coordinate Clinical activities on local multi-center trials
Analyzes data in metrics reports related to sites activation, monitoring, data retrieval and close out to identify issues and risks to clinical deliverables; develops contingency and mitigation plans to minimize risks; communicates risks & mitigation strategies to Project Director, Functional Manager, and other senior staff as needed
Liaises with Clinical Operations Managers to resolve clinical resource and performance issues
Disseminates and agrees forecasted activities/FTE to all key team members
Coordinate and oversee with regular tasks for Quality assurance, Quality control, Safety department, Regulatory Affairs department, Translation vendor, Vendor Management, Drug&Facility Vendor within scope of contract
Reporting to higher management team of Company for the progress of the studies regularly
Conduct the scope and contract management and review the financial metrics reports
Coordinate out-out-scope change approval and master service contract amendment change
Support as buddy within project management team for new team members

Project Manager

WuXi Clinical Development Services (Shanghai) Co., Ltd,

04.2016 - 06.2017

Plans, oversees and conducts initial and ongoing training for the study team on clinical project specifics
Coordinate Clinical activities on international multi-center trials and conduct site management activities after appropriate training including pre-study site visit, site initiation visits, site training and site routine monitoring visits
Supports the Clinical Research Associates (CRAs) with site monitoring activities and provides suggestions and solutions to site issues where applicable
Oversees the CRA and IHCRA to ensure all initial or amended trial information is submitted, approved and filed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trial
Analyzes data in metrics reports related to sites activation, monitoring, data retrieval and close out to identify issues and risks to clinical deliverables; develops contingency and mitigation plans to minimize risks; communicates risks & mitigation strategies to Project Director, Functional Manager, and other senior staff as needed
Liaises with Clinical Operations Managers to resolve clinical resource and performance issues
Disseminates and agrees forecasted activities/FTE to all key team members
Coordinate and oversee with regular tasks for safety department, Regulatory Affairs department, translation department, and third-party vendor (SMO) within scope of contract
Coordinate with clients with clinical and project management activities within timelines, quality and scope
Conduct the scope and contract management and review the financial metrics reports
Support and present in Biding Defense meetings

Clinical Team Manager

Wuxi PRA (Shanghai) Co., Ltd (former RPS)

01.2014 - 03.2016

Plans, oversees and conducts initial and ongoing training for the study team on clinical project specifics
Coordinate Clinical activities on international multi-center trials and conduct site management activities after appropriate training including pre-study site visit, site initiation visits, site training and site routine monitoring visits
Supports the Clinical Research Associates (CRAs) with site monitoring activities and provides suggestions and solutions to site issues where applicable
Oversees the CRA and IHCRA to ensure all initial or amended trial information is submitted, approved and filed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trial
Analyzes data related to sites activation, monitoring, data retrieval and close out to identify issues and risks to clinical deliverables; develops contingency and mitigation plans to minimize risks; communicates risks & mitigation strategies to Project Director, Functional Manager, and other senior staff as needed
Liaises with Clinical Operations Managers to resolve clinical resource and performance issues
Disseminates and agrees forecasted activities/FTE to all key team members
Coordinate and oversee with regular tasks for safety department, Regulatory Affairs department, translation department and third-party vendor (SMO) within scope of contract
Reporting to higher management team of Company for the progress of the studies regularly
Coordinate with clients with clinical and project management activities within timelines, quality and scope
Conduct the scope and contract management and review the financial metrics reports
Coordinate out-out-scope change approval and master service contract amendment change.

Clinical Team Lead

ReSearch Pharmaceutical Services, RPS

07.2013 - 12.2013

Coordinate Clinical activities on international multi-center trials and conduct site management activities after appropriate training including pre-study site visit, site initiation visits, site training and site routine monitoring visits
Supports the Clinical Research Associates (CRAs) with site monitoring activities and provides suggestions and solutions to site issues where applicable
Oversees the CRA and IHCRA to ensure all initial or amended trial information is submitted, approved and filed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trial
Analyzes data related to sites activation, monitoring, data retrieval and close out to identify issues and risks to clinical deliverables; develops contingency and mitigation plans to minimize risks; communicates risks & mitigation strategies to Project Director, Functional Manager, and other senior staff as needed
Coordinate CRA activities on the study in partnership with the Project Manager and their Clinical
Research Managers
Support project management in the development and review of study-related documents, i.e., protocol, "(electronic)" CRFs, and ICFs
Conduct site management activities after appropriate training including site training, site pre-study visit training, site initiation visit and site routine monitoring visits.

Senior Clinical Research Associate

ReSearch Pharmaceutical Services, RPS

02.2012 - 06.2013

Conduct site management and clinical operation activities on international multi center trials
Implement strategies to ensure timely subject recruitment
Essential records management
Insure that all the clinical research related records are veracity and integrity
Maintain customer and keep positive relationship with sponsor and investigator
Monitoring activities: site recruitment, selection, initiation, routing monitoring, and site close out visit
IP management, including IP supplies, storage, distribution, and return
Assist with investigator meeting activities including organization, preparation and attendance
Manage clinical trials including study budget management and identifying, assessing and contracting suppliers of Central Pharmacy and Regional Laboratory services
Conduct the re-source verification and quality control supporting activities to multiple studies

Clinical Research Associate II

PAREXEL CHINA CO., LTD

04.2010 - 01.2012

Conduct site management and clinical operation activities on international multi center trials
Implement strategies to ensure timely subject recruitment
Essential records management
Insure that all the clinical research related records are veracity and integrity
Maintain customer and keep positive relationship with sponsor and investigator
Monitoring activities: site recruitment, selection, initiation, routing monitoring, and site close out visit
IP management, including IP supplies, storage, distribution, and return
Assist with investigator meeting activities including organization, preparation and attendance
Manage clinical trials including study budget management and identifying, assessing and contracting suppliers of Central Pharmacy and Regional Laboratory services

Clinical Research Associate

PPD

06.2008 - 03.2010

Coordinates & monitors Clinical activities on multi center trials
Essential records management
Insure that all the clinical research related records are veracity and integrity
Maintain customer and keep positive relationship with sponsor and investigator
Monitoring activities: site recruitment, selection, initiation, routing monitoring, and site close out visit
IP management, including IP supplies, storage, distribution, and return

Summary

Overview

Work History

Global Project Director

Associate Global Project Director

Associate Global Project Director

Senior Project Manager

Senior Project Manager

Project Manager

Project Manager

Clinical Team Manager

Clinical Team Lead

Senior Clinical Research Associate

Clinical Research Associate II

Clinical Research Associate

Education

Master - Evidence-Based Medicine

Bachelor - Clinical Medicine

Skills

Certification

Therapeutic Area Expertise

Association Membership

Publications

Training

Summary Of Experience

Languages

Timeline

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