Covance Clinical Operations Manager in Munich, Delaware
Performance: Accountable for performance and compliance for assigned
protocols in a country in compliance with ICH/GCP and country
regulations, policies and procedures, quality standards and adverse
event reporting requirements internally and externally.
Management: POC for assigned protocols between ROC and CO. Proactively
drives/tracks execution and performance of deliverables/
timelines/results to meet country commitments for assigned protocols.
Strong collaboration with local CO roles. Forecasts country resource
needs. Serves local business needs (signs contracts, manages
budgets as delegated)
External Customer Facing: Responsible for collaboration with functional
outsourcing vendors, investigators, and other external partners.
Oversees country and site validations, site selection and recruitment in
assigned protocols. Responsible for clinical trial education to sites.
Country POC for programmatically outsourced trials for assigned protocols.
Quality Oversight: Responsible for quality and compliance in assigned
protocols in country. Oversees CRAs and CTCs. Oversees training
compliance. Performs quality control visits. Reviews Monitoring Visits
Reports and escalates performance issues and training needs to functional
vendor and internal management as needed.
Internal Collaboration & Strategy: Collaborates internally with local PV,
Regulatory, GMA/GHH to align on key decisions in countries. Supports
local and regional strategy development consistent with long-term corporate
needs in conjunction with CRD and Regional Operations.
Education / Qualifications
degree in life sciences or equivalent experience in clinical research
Experience in role
Oncology experience preferred
English fluent written and oral
experience or ability/willingness to instruct and lead teams
Job Number 2018-20265
Job Category Clinical Operations
Position Type Full-Time
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