Operations Manager, Clinical Research

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.

Company 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.