PSI CRO AG

Regional Clinical Operations Manager

PSI CRO AG

full-time

Posted on:

Location Type: Remote

Location: BulgariaGermany

Visit company website

Explore more

AI Apply
Apply

About the role

  • Take end-to-end operational responsibility for clinical research projects within the assigned region.
  • Ensure effective execution of clinical trials in line with study protocols, timelines, quality standards, and regulatory requirements.
  • Oversee site qualification process and ensure smooth study start-up, including site contracting support, site activation, and coordination with internal and external stakeholders.
  • Lead, manage, and support regional teams of operational and BD staff.
  • Act as a mentor and escalation point for coordinators facing operational challenges.
  • Proactively manage risks, troubleshoot operational bottlenecks, and lead local resolution
  • Collaborate closely with internal global teams to ensure alignment, clear communication, and seamless project execution.
  • Monitor operational KPIs, prepare progress reports, and implement corrective actions where needed.
  • Represent Milestone One in operational discussions with sponsors, partners, and at selected industry meetings.

Requirements

  • Minimum 5 years of experience in leading clinical trial operations within an SMO or CRO
  • Proven hands-on experience in managing clinical trial operations, including site start-up, contracting processes, and ongoing site management.
  • Strong understanding of clinical trial logistics, investigational product handling, and supply management.
  • Demonstrated experience in leading and developing teams of study coordinators or operational staff.
  • Ability to independently manage and resolve complex, real-time operational issues.
  • Excellent organizational, communication, and stakeholder management skills.
  • Fluent English
  • Experience working in an international and cross-functional environment.
Benefits
  • Flexible work arrangements
  • Professional development

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical trial operationssite start-upcontracting processessite managementclinical trial logisticsinvestigational product handlingsupply managementrisk managementKPI monitoringprogress reporting
Soft skills
leadershipmentoringproblem-solvingcommunicationstakeholder managementorganizational skillsteam developmentcollaborationindependent managementtroubleshooting