JOB TITLE: SENIOR CLINICAL PROJECT MANAGER, ITALY - P

Description.
Location.
Italy - Home or office based       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, is recruiting for a Senior Clinical Project Manager to join their clinical operations team.
This is a permanent opportunity in Italy.
You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.
As a Senior Clinical Project Manager, you will be responsible, for oversight of assigned clinical projects ensuring the quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines, and other, applicable regulations.
You may also act as Project Director/Leader, depending on the complexity of the projects.
Previous experience with respiratory and oncology trials is preferred.
A minimum of 3 years of experience with a CRO is needed.
Join our team and help us deliver clinical trials that will improve patients' lives.
Main Tasks and Responsibilities.
Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators, and coordinating the project team members.
Oversees the application process for clinical studies, in force in the country(ies) of work.
Verifies the assigned project activities plan and timelines and the related critical state.
Manages the budget of the project.
Participates in Monitor's and Investigator's Meetings Provides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.
Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the Sponsor.
Supervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulations.
Undertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levels.
May provide oversight and mentoring for junior staff assigned to the projects.
Supervises the archiving activities.
Supervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc…) Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs), and final Clinical Study Reports (CSRs) Performs, if necessary, co-monitoring visits for the assigned clinical projects.
May act as Feasibility Associate (FEA) after appropriate and documented training.
May prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU) Arranges and collaborate with the assigned Clinical Research Department Director, in identifying the project-specific training of the project team and in delivering them.
Education and Experience Required.
University Degree in scientific, medical, or paramedical disciplines with 3 years of experience Significant 3 years of experience in clinical project management 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.
., Word, Excel, Outlook) Willingness to travel.
The Benefits of Working in Italy.
· Meal vouchers · Mobile phone if requested by the Line Manager · Dedicated Line Manager   Who will you be working for?                                      About CROMSOURCE                       CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since , 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 can 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 all personnel the clear tools needed to manage both internal and client processes with the same methodology.
The success of these core values is evidenced by our below-industry average turnover rates.
The Application Process                   Once you have submitted your CV, you will receive an acknowledgment that we received it.
If you have the requirements we need, you will be invited for a 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 @ http://www.
romsource.
om/careers/job-vacancies please contact [email protected] for more information.
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, 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, Respiratory, Oncology, Ophthalmology Skills.
Clinical Project Manager, Clinical Study Manager, Clinical Trial Manager, Senior Clinical Project Manager, clinical trials, CRO, Medical Devices, Study Management Location.
Italy