Description:
Location: Home or office based in Verona or Milan, Italy

Schedule: Permanent, Full-time

Do you want to join a team that is passionate about making a difference in drug and medical device development? CROMSOURCE, a growing CRO, are looking for a dynamic person to join our in-house team. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.

As a Clinical Project Manager I you will be responsible for managing the clinical projects ensuring quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines and other applicable regulations.

Main Tasks and Responsibilities

• Manage and coordinate the assigned clinical projects
• Manage all project specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.)
• Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators under the supervision of the Project Manager II or Senior Project Manager
• Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned
• Knowledgeable in the application process for clinical studies, in force in the country/ies of work.
• Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondance, etc.)
• May act as a Technical Specialist supervising the projects within specific therapeutic and technical areas
• Assure the proper timelines of the assigned projects
• Coordinate the Clinical Research Associates and Clinical Monitors activity
• Collaborate with he Clinical Trial Administrators and Clinical Research Associates in terms of local authorities approval activities
• Collaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)
• Collaborate with the CTAs in archiving activities
• Deliver project specific trainings in function of expertise
• Organise and participate in Monitor and Investigator Meetings
• Take part in the periodic project update meetings
• Inform the Project Manager II and Senior Project Manager of any issues
• Perform co-monitoring visits for the assigned clinical projects as necessary
• Maintain relationships with the Sponsor, including providing project updates
• Prepare the SOPs relating to clinical research activities in collaboration with the Quality System Unit
• Collaborate in complying and enforcing Company procedures

Education and Experience Required

• University Degree in scientific, medical or paramedical disciplines
• Experience in clinical project management or coordination activities in the CRO/pharmaceutical industry
• Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
• Fluent in English and local language(s)
• Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
• Willingness to travel

The Application Process

Once you have submitted your CV, you will receive an acknowledgement email. If you have the requirements we need, you will be invited for phone interview as the first step.

If you would like to discuss the role before applying through the website @ www.cromsource.com/careers/job-vacancies please contact careers@cromsource.com for more information.

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.

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: Project Manager, Clinical Project Manager, Project Coordinator, Junior Project Manager, Junior Study Manager, Study Management Associate, Project Management Associate, CRO, Clinical Research Organisation, Contract Research Organisation, Clinical, Drugs, Medical Devices, Medical Device, Project Management, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, Belgium

Skills: Clinical Project Manager Location: Italy Share:

LinkedIn Facebook Twitter Email