Covance is searching for Clinical Research Manager for our sponsor in Munich, to be office based.
Performance: Accountable for performance and compliance for assigned
protocols in a country in compliance with ICH/GCP and country
regulations, company policies and procedures, quality standards and adverse
event reporting requirements internally and externally.
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 functionaloutsourcing vendors, investigators, and other external partners.
Oversees country and site validations, site selection and recruitment in
Responsible for clinical trial education to sites.
Country POC for programmatically outsourced trials for assigned protocols.
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.
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