PSI CRO

Global CRO delivering on-time patient enrollment

Operations Manager - Clinical Research

Clinical Research OperationsPosted on Nov 9

Full-timeTaipei City, TaiwanNo salary listedRemote

About the Job

Requirements

An associate degree in life sciences is required; a business management degree or certification is a plus.
ICH GCP training certification is required.
A minimum of five years of clinical on-the-job experience is required.
Knowledge and direct experience across the full life cycle of clinical research activities, from pre-award through closeout, are required.
Fluent use of English is required.
Proficiency in Microsoft Office is required.
A valid category B driver’s license is required.
Experience managing remote staff is preferred.
Strong communication, management, problem-solving, results-oriented, accountability, and team leadership capabilities are required.

Responsibilities

Assess research protocol feasibility by reviewing clinical, operational, and resource requirements and recommending suitable trials for the medical institution.
Monitor budget negotiation progress and study activation timelines to support timely site readiness.
Manage the team of Lead Study Coordinators and Study Coordinators; oversee the quality and results of their work through monitoring and follow-up of study-related reports, timesheets, site trackers, and other operational tools.
Drive process improvement and standardization of clinical trial operations in alignment with ICH GCP, regulatory requirements, and MO1 Controlled Documents; contribute to developing operational guidelines, templates, and procedures.
Create a work culture that promotes process transparency, accountability, and continuous learning.

Desired Qualifications

A business management degree or certification is a plus.
Leadership experience at a clinical research facility or network experience is highly preferred.
Experience managing remote staff is preferred.

Job Description

The Manager Operations is responsible for overseeing the operational conduct of clinical trials at

contracted medical institutions within a defined country or region in accordance with Milestone One

contractual obligations. The Manager Operations provides leadership to Lead Site Coordinators and

Site Coordinators, serving as a subject matter expert and escalation point for operational issues. This

position plays a key role in staff development, process improvement, and continuous operational

excellence.

SCOPE OF RESPONSIBILITIES

Assesses feasibility of research protocols by reviewing clinical, operational, and resource requirements and recommending suitable trials for the medical institution.
Monitors the progress of budget negotiations and study activation timelines to support timely site readiness.
Manages the team of (Lead) Study Coordinators, oversees the quality and results of their work by monitoring and follow-up of study related reports, timesheets, site trackers and other operational tools to ensure satisfactory performance of the Milestone One team.
Drives process improvement and standardization of clinical trial operations in alignment with ICH GCP, regulatory requirements, MO1 Controlled Documents, by contributing to the development of operational guidelines, templates, and procedures.
Creates a work culture environment that promotes process transparency, accountability, and continuous learning.

Qualifications

Associate degree in life sciences or similiar. Business Management degree or certification is a plus.
Certifications ICH GCP Training
Minimum 5 years of clinical on the job experience, in a leadership position at a clinical research facility or Network experience is highly preferred.
Knowledgeable and direct experience in the full life cycle of clinical research activities from pre-award through close out.
Fluent use of English
Proficiency in MS Office
Valid category B driver’s license
Excellent communications skills
Excellent management skills, experience managing remote staff preferred.
Effective problem solving and result oriented
Accountable
Team leadership skills

Additional Information

If you want to join a developing company where people matter, you're independent and accountable, Milestone One is the right place for you.

About the Company

PSI CRO

Global CRO delivering on-time patient enrollment

PSI CRO is a global contract research organization that handles clinical trials for multiple therapeutic areas, with a focus on enrolling patients on schedule and delivering studies on time. Its services span feasibility assessments, trial planning, site selection, patient recruitment, and multi-continent trial execution across 50+ countries, backed by medical doctor resources dedicated to accurate timeline predictions. Unlike many CROs, PSI emphasizes predictable enrollment and on-time project delivery, aiming for high client satisfaction and repeat business through a pragmatic, no-nonsense approach. The company’s goal is to be regarded as the best CRO in the world by both clients and employees, achieved through reliable timelines, strong execution, and low staff turnover.

Company size: 1,001-5,000
Company stage: Not listed
Total funding: Not listed
Headquarters: Switzerland
Founded: 1995

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