Operations Manager, Clinical Research

Psicro; United States; On-site; USD 90,000 - 150,000; Full time

Job summary

Milestone One is seeking a Manager Operations to oversee the clinical trial operations at contracted sites within a defined country or region. The role provides leadership to Lead Site Coordinators and Site Coordinators, serving as a subject matter expert and escalation point for operational issues.

This position emphasizes staff development, process improvement, and continuous operational excellence in line with ICH GCP standards and MO1 procedures.

Qualifications

• Minimum 5 years of clinical on-the-job experience in a leadership position at a clinical research facility or network
• Knowledgeable in the full life cycle of clinical research from pre-award through close-out
• Fluent use of English
• Proficiency in MS Office
• Excellent communications skills
• Excellent management skills; experience managing remote staff preferred
• Accountable
• Team leadership skills
• Certifications: ICH GCP Training
• Associate degree in life sciences; business management degree or certification is a plus

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 and Site Coordinators, overseeing quality and results of their work
• Drives process improvement and standardization of clinical trial operations in alignment with ICH GCP and MO1 documents
• Creates a work culture environment that promotes process transparency, accountability, and continuous learning

Skills

English fluency

Communication skills

Management skills

Team leadership

Problem solving

Accountability

Education

Associate degree in life sciences

Business management degree or certification

Tools

MS Office

Job description

The Manager Operations is responsible for overseeing the operational conduct of clinical trials atcontracted medical institutions within a defined country or region in accordance with Milestone Onecontractual obligations. The Manager Operations provides leadership to Lead Site Coordinators andSite Coordinators, serving as a subject matter expert and escalation point for operational issues. Thisposition plays a key role in staff development, process improvement, and continuous operationalexcellence.

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.

• 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

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