Location: Milan, Italy - office based
Schedule: Full-Time, Permanent
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds….
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.
CROMSOURCE is an international CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.
Scope of the role:
The Project Manager will oversee a large Phase III onco-haematology study and will be responsible for assuring the coordination of the operational aspects and proper conduct of a clinical study, including compliance with ICH/GCP, Client policies and Standard Operating Procedures.
Main Job Tasks and 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
- 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
The Benefits of Working for TalentSource in Italy
- 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
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
If you would like to discuss the role before applying through the website @
Who will you be working for?
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, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Keywords: Clinical Project Manager, Project Manager, Project Lead, Project Leader, Study Manager, Project Coordinator, Clinical Research Manager, Clinical Team Manager, Clinical Lead, Clinical Operations Leader, PM, PL, SM, COL, COLA, CRM, CTM Junior, Contract Research Organisation, CRO, Outsourced, Pharmaco, Pharmaceutical, Phase III, Phase 3, Oncology, Haematology, Onco-Haematology, Rare Disease
Haematology, Oncology, Rare Disease, Clinical Lead, Clinical Project Manager, Clinical Research Manager, Clinical Study Manager, Clinical, Clinical Research Organisation, CRO