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Job Details
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Clinical Research Manager

Business Type: Clinical Research Organisation
Job Type: Clinical Research
Job Level: Entry Level
Position: Full Time
Location: Italy
Reference: 69614
Closing Date: 20/09/21
Job Details:

My Client is a strongly innovative international CRO based in Milan. They provide biopharmaceutical, pharmaceutical and medical devices companies with qualified and talented professionals to accelerate the development and delivery of new therapies.
For results-driven and caring individuals who want to make a meaningful difference in the world, my client is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything they do, and transforming your career into a life-changing achievement. The client is looking for a Clinical Research Manager.
Primary Duties:
* Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT)
* Responsible for project management of the assigned studies:
o Proactively plans/drives/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 country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally
o Performs quality control visits as required
o Reviews Monitoring Visits Reports (MVRs) and escalates performance issues and training needs to CRA manager and /or functional vendor and internal management as needed
* Leads local study teams to high performance:
o Trains in the protocol other local roles
o Closely collaborates with and supports Clinical Research Associates (CRAs) as protocol expert
o 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 Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF) and other key systems in assigned studies
Escalates as needed different challenges and issues to Therapeutic Area (TA) Director / Clinical Research Director (CRD) / Clinical Quality Management (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)
* Shares protocol-specific information and best practices across countries/clusters
* Strong collaboration with local/cluster roles, experience in identifying and sharing best practices across clinical trials, countries, clusters
* Oversees accountability for country/cluster and site validations, site selection and recruitment in assigned protocols
* Country/cluster POC for programmatically outsourced trials for assigned protocols
* Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TAH and Regional Operations
* Lead and contribute to initiatives and projects adding value to the business and supporting the strategy
* Responsible for quality and compliance in assigned protocols in country/cluster
* Coordinate study Clinical Trial Coordinator (CTC), Clinical Trial Associates (CRAs), Clinical Operation Manager (COM)
* Contributes to CRM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required
* Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training
* Adheres to EP and Client SOPs and processes

Skills and Education:
* Bachelor''s degree in Science (or comparable) required; advanced degree (Master''s degree, MD, PhD) preferred
* 5-6 years of experience in clinical research
* CRA experience is a must

If this role sounds like something you would be interested in, please send your CV to my email address or via Linkedin.

If this role is not quite right for you but you would like to have a conversation about other roles, do not hesitate to connect with me.

NonStop Consulting Limited Posted by:: NonStop Consulting Limited (View all our vacancies)
Unless otherwise stated, if applying for a job, you must ensure that you are already authorised to work in the country in which the job is based
Posted: 13/09/2021 | NPJ Ref: 282516
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