Covance Clinical Operations Manager in Munich, Delaware

Job Overview

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

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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