Debiopharm
biopharmaceutical
ClinicalOperationalSpecialist(COS)
“Clinical Operational Specialist (COS) at Debiopharm. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. Manage Clinical Trial Team meetings, prepare minutes, and follow up on outstanding actions.. Ensure all delegated operational trial deliverables are met according to timelines, budget, operational procedures, and quality standards.”
What You'll Achieve.
ensuring high quality and precision from trial setup through to archiving; ensuring constant audit readiness
Industry & Context.
What They're Looking For.
Must Have
3 years in the pharmaceutical industry, preferably in clinical research, Highly organized with the ability to prioritize multiple tasks in a matrix organization, collaborative, flexible, proactive, very good communication
Nice to Have
Fluent in French or other European languages are a plus
What You'll Do.
Manage Clinical Trial Team meetings
and follow up on outstanding actions.
Ensure all delegated operational trial deliverables are met according to timelines
operational procedures
and quality standards.
Collect and track trial status such as enrolment and timelines to monitor the trial progress and to update the relevant internal/external boards (e. g.
Development Leadership Team
and Leadership Team).
Collaborate with TMF Specialists to set up
and archive the Trial Master File
ensuring constant audit readiness.
Manage & oversee IRB/IEC submission plans
set up clinical trial insurance
and oversee vendor systems set up/management such as IRT.
Assist with CRO/vendor oversight/tracking
invoice reconciliation
and purchasing order generation.
Prepare materials for investigator meetings
and internal newsletters.
How You'll Work.
Team & Collaboration
Manage Clinical Trial Team meetings; Collaborate with TMF Specialists; Assist with CRO/vendor oversight/tracking; Partner with teams across disciplines
Communication Scope
very good communication; Prepare materials for investigator meetings, advisory boards, and internal newsletters.
Process & Methodology
Trial Coordination, Trial management, Reporting, Operational Setup, Vendor Oversight
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