Are you an experienced Clinical Project Manager in either Verona or Milan, looking to join a great company with a reputation for looking after their employees and having a great work-life-balance. This is a permanent, full-time position within our internal CRO.
The ideal candidate will have proficient experience within oncology clinical trials, as well as be able to work cross-functionally to ensure quality, budget and timelines are met. You will be the central point of communication for all clinical trial related activities to assure trials are conducted on time and budget, while being fully GCP, ICH and SOP compliant.
The PM may act as Project Leader and as Clinical Team Leader in Stand-alone Monitoring/Start up projects. Major Accountabilities:
Requirements and skills:
- Management of global, multi-center clinical projects: oncology, rare diseases, medical device, respiratory and ophthalmology to budget, time and quality and to sponsor high levels of satisfaction and provides regular updates to key stakeholders.
- Collaborates, 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…)
- Ensures set-up and maintenance of all systems in order to plan and implement the study and track progress
- Has oversight of the local authorities approval activities undertaken by the team and is knowledgeable in the submission process in force in the country(ies) of work. Tracks Regulatory and IRB submissions
- Supports site feasibility efforts and study start-up activities including budget/contract negotiations and ensures global feasibility of site and oversight of the contractual agreements
- Accountable for study related communications and for resolution or escalation of operational issues with all related project members and departments
- Ensures development, review, finalisation and delivery of high quality key clinical study documents in order to meet study timelines
- Manges 3rd party vendors (centralized lab exams, drug shipments, documents shipment, etc.)
- May assist the Medical Monitor in preparing protocols, Case Report Forms (CRFs) and final Clinical Study Reports (CSRs)
- Monitors the workload and the performance of the project team, planning and assigning tasks for the team and if necessary, performs co-monitoring visits
- Organises and participates in Monitor's and Investigator's Meetings and any project specific trainings
- Acts as mentor for Project Coordinators and has some oversight of Clinical Trial Assistants
- May be involved in preparing SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)
Who will you be working for? About CROMSOURCE:
- Educated to degree level (biological sciences, pharmacy or other health related discipline preferred) or relevant experience in a medical/nursing field
- At least 3 years of experience as a Clinical Project Manager, preferably within a CRO environment
- Preferably experience in Oncology
- Experience of monitoring clinical trials to ICH/GCP
- Excellent interpersonal, verbal and written communication skills (in English)
- Ability to motivate both individually and collectively
- Excellent problem solving capability through early identification
- Willingness to travel
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. 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 @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002289
or contact Alessandra.Bolognani@cromsource.com 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 management, project manager, oncology, clinical trials, CRO, Verona
Skills: Oncology, Project Management Location: Italy, Verona Share:
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