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.
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
If you want to join a developing company where people matter, you're independent and accountable, Milestone One is the right place for you.
Skills Required
- Associate degree in life sciences or similar
- ICH GCP training / certification
- Minimum 5 years clinical on-the-job experience in a leadership position
- Knowledge and direct experience across full lifecycle of clinical research from pre-award through close-out
- Fluent English
- Proficiency in MS Office
- Valid category B driver's license
- Excellent communication skills
- Excellent management skills
- Experience managing remote staff
- Network experience
- Business Management degree or certification
- Effective problem solving and result orientation
- Accountable with team leadership skills
What We Do
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com
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