Covance Clinical Research Manager - Sponsor Dedicated in Milan, Italy
This role is primarily accountable for the end to end performance 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.
The CRM could be responsible for a particular study for several countries in a cluster.
Responsibilities include, but are not limited to:
Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
Accountable for performance 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.
Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
Performs Quality control visits as required
Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
Responsible for creating and executing a local risk management plan for assigned studies
Ensures compliance with CTMS, eTMF and other key systems in assigned studies
Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (as appropriate)
Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
Country POC for programmatically outsourced trials for assigned protocols.
Serves local business needs as applicable in his/her country(If delegated can sign contracts and manage budgets)
Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies. GHH to be consulted as needed.
As a customer-facing role, this position will build business relationships and represent the company with investigators
Shares protocol-specific information and best practices across countries\clusters
Education / Qualifications
Bachelor degree in Science (or comparable)
Advanced degree, (e.g., Master degree, MD, PhD)
Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
5-6 years of experience in clinical project management of which 3 as CRA
Knowledge in Project/Site Management.
Strong organizational skills with demonstrated success required.
Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Head or CRD
Requires strong understanding of local regulatory environment
Strong scientific and clinical research knowledge is required
Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery
Job Number 2018-21099
Job Category Clinical Operations
Position Type Full-Time
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