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