Operations Manager - Clinical Research

About Milestone One

Milestone One is a Site Enabling Services organization headquartered globally in Zug, Switzerland. The company focuses on addressing the needs of clinical study sites with the mission of enhancing study delivery effectiveness.

Job Overview

The Operations Manager will oversee the conduct and management of clinical trials across contracted medical institutions within a designated country or region. This role ensures adherence to contractual commitments and provides leadership to Lead Site Coordinators and Site Coordinators. Serving as a subject matter expert and escalation point, the Operations Manager plays a pivotal role in staff development, process refinement, and the pursuit of operational excellence.

Key Responsibilities

• Evaluate the feasibility of research protocols by analyzing clinical, operational, and resource needs, advising on appropriate trials for each medical institution.
• Track budget negotiation progress and study activation timelines to facilitate prompt readiness of sites.
• Lead and supervise the team of Lead Study Coordinators and Site Coordinators, ensuring quality and compliance through monitoring reports, timesheets, site trackers, and other operational tools.
• Advocate and implement process improvements and standardization aligned with ICH GCP guidelines, regulatory standards, and company protocols by contributing to the development of operational procedures and templates.
• Foster a workplace culture emphasizing transparency, accountability, and continuous learning.

Qualifications and Skills

• Associate degree in life sciences or a related field; business management certifications or degrees are advantageous.
• Certification in ICH GCP training is required.
• Minimum of five years’ clinical experience, preferably in a leadership role within clinical research facilities or networks.
• Comprehensive understanding and direct involvement in the entire clinical research cycle from pre-award phase through study closeout.
• Fluency in English language.
• Proficiency with Microsoft Office applications.
• Possession of a valid category B driver’s license.
• Exceptional communication and management skills, with experience managing remote teams preferred.
• Strong problem-solving capabilities and a results-driven approach.
• Demonstrated accountability and team leadership abilities.

Additional Information

Milestone One offers a dynamic work environment for independent, responsible individuals who value accountability and want to contribute to a growing company where people are prioritized.