Overview
Location: Milan, Italy - office based
Schedule: Full-Time, Permanent
TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE) is searching for a Clinical Project Manager to join one of our partner companies - an Italian pharmaceutical company, based in Milan. Scope of the role includes overseeing a large Phase III onco-haematology study and coordinating the operational aspects and proper conduct of a clinical study, including compliance with ICH / GCP, Client policies and Standard Operating Procedures.
Responsibilities

Accountable for study execution, tracking and management of study delivery
May manage feasibility
Tracks Regulatory and EC submissions, with medical team
Maintains the global study budget, ensuring cost effectiveness and addressing and escalate issues as appropriate
Ensures set up and maintenance of all systems in order to plan and implement the study and track progress
Ensures appropriate clinical trial supply strategy is implemented and managed
Develops recruitment plan, manages risk, monitors progress and implements contingencies as required
Ensures efficient streamlined processes are in place to deliver study to plan and ensure safety of patients and completeness / integrity of data
Ensures adherence to Good Clinical Practice and all applicable local and international regulations
Ensures for timely delivery of scientifically and operationally robust study documents
Ensures development, review, finalisation and delivery of high quality key clinical study documents in order to meet study timelines
Ensures accurate maintenance and archiving of study records
Ensures global feasibility of site contractual agreements
Accountable for site and monitor training in operational aspects of the study
Ensures monitoring and site personnel are familiar with all study-specific processes, procedures and systems and that training is adequately documented. Manages CRAs at the clinical level
Ensures continuous direct contact with in-country personnel to provide ongoing operational support
Accountable for study related communications and for resolution or escalation of operational issues

Education and Experience

Educated to degree level (biological sciences, pharmacy or other health related discipline preferred)
Substantial experience in Clinical Research including previous Global Study Management experience

Skills

Competent in written and oral English
Excellent interpersonal, verbal and written communication skills
Client focused approach to work
Excellent team leadership skills
Ability to motivate both individually and collectively
Excellent problem solving capability through early identification
Demonstrate, appreciation and understanding of finance and budgeting issues
Excellent computer literacy

Benefits

Meal vouchers
Mobile phone if requested by the Line Manager
Dedicated Line Manager
Monthly meetings with line manager
Full performance and development process with end of year reviews
Team events and end of year party
Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
Employee satisfaction survey - your feedback is important for continuous improvement

Application Process
Who will you be working for?
About CROMSOURCE
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.
About TalentSource Life Sciences
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whils
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