• Clinical Operations Manager

    Job Location(s) DE-Munich
    Job Number
    Job Category
    Clinical Operations
    Position Type
  • 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 in role

    Oncology experience preferred

    English fluent written and oral

    experience or ability/willingness to instruct and lead teams


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