Note: The job is a remote job and is open to candidates in USA. Milestone One is a Site Enabling Services organization that supports clinical study sites in stronger study delivery. The Operations Manager oversees the operational conduct of clinical trials, leads study coordination staff, and drives staff development, process improvement, and operational excellence.
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
Skills
- Associate degree in life sciences or similiar
- Certifications ICH GCP Training
- 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
- Effective problem solving and result oriented
- Accountable
- Team leadership skills
- Business Management degree or certification is a plus
- Minimum 5 years of clinical on the job experience, in a leadership position at a clinical research facility or Network experience is highly preferred
- Excellent management skills, experience managing remote staff preferred
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