Operations Manager, Clinical Research

Milestone One; United States; On-site; USD 110,000 - 160,000; Full time

Job summary

Milestone One is a Site Enabling Services organization; a Manager Operations is sought to oversee the operational conduct of clinical trials at contracted sites within a defined country or region. You will lead Lead Site Coordinators and Site Coordinators, acting as SME and escalation point for operational issues.

This role emphasizes staff development, process improvement, and adherence to ICH GCP and MO1 documents, with focus on feasibility assessment, budgeting, study activation timelines,

Qualifications

• Associate degree in life sciences; business management degree or certification is a plus.
• ICH GCP Training certification is required.
• Minimum 5 years of clinical experience in a leadership position at a clinical research facility or network preferred.
• Fluent English.
• MS Office proficiency.
• Valid category B driver's license.
• Excellent communications skills and management capabilities; remote staff experience preferred.
• Effective problem solving and results orientation; accountable.
• Team leadership skills.

Responsibilities

• Assess feasibility of research protocols by reviewing clinical, operational, and resource requirements and recommending suitable trials for the medical institution.
• Monitor the progress of budget negotiations and study activation timelines to support timely site readiness.
• Manage the team of (Lead) Study Coordinators, oversee 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.
• Drive 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.
• Create a work culture environment that promotes process transparency, accountability, and continuous learning.

Skills

Leadership

Communication

Problem solving

Team leadership

Accountability

Education

Associate degree in life sciences

Business Management degree or certification

ICH GCP Training Certification

Tools

MS Office

Job description

Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery.

Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery.

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.