Clinical Study Manager

Purpose of the Job

Contributes, with appropriate oversight, to all aspects of assigned clinical trials to deliver within timelines, budget, quality standards. May lead specific aspects of global clinical trial(s).

Main Duties

Contributes to all operational trial deliverables, under the oversight of the Global Trial Operations Director, according to timelines, budget, quality standards. Assigned responsibilities can include but are not limited to:

Contributing to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting, and publishing

Development of study tools, guidelines, and training materials;

Contributing to the development of clinical outsourcing specifications to facilitate bid process and selection of Contract Research Organizations (CROs); responsible for management of CROs;

Managing interactions with relevant line functions including data management, drug supply management, clinical development;

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;

Supporting forecast and management of drug supply;

Implementing operational issue and risk mitigation plans, highlighting potential risks and actions;

Organization and logistics of various trial advisory boards (e.g., data monitoring committee, steering committee)

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

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

Support the development, management, and tracking of trial budget working closely with the appropriate partners.

Accountable for accuracy of trial information in all trial databases and tracking systems.

Responsible for implementation of best practices and standards for trial management within OGD, including sharing lessons learned.

Job Qualifications

Advanced degree or equivalent education/degree in life science/healthcare is preferred.

PHD ≥3 years of experience，master degree ≥5 years of experience and bachelor ≥7 years of experience in clinical development.

Experience in managing cross-functional, global clinical trials; demonstrated capabilities in supporting operational aspects of clinical trial related activities.

Demonstrated ability to work either independently or in a team setting

Experience in planning, risk mitigation strategies, trial budget, clinical supplies, sample management, site selection, conduct and monitoring of clinical trials

Excellent communication, organization and tracking skills

Demonstrated ability to network and share knowledge and experience amongst colleagues.

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

Experience in oncology and/or hematology indications is preferable.

Fluent English (oral and written).