Location: Italy - Home based or Office based in Verona or Milano
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 internal team in Italy. This role is a full time permanent opportunity. 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 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 and properly coordinating the project team members
- 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, correspondence, etc.)
- May act as a Technical Specialist supervising the projects within specific therapeutic and technical areas
- Assure the proper timelines of the assigned projects
- Manage the budget for the project
- Monitor the workload and the performance of the project team
- Plan and monitor the tasks of the team in the specific areas
- 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
- Assist the Medical Monitor in preparing protocols, Case Report Forms and final Clinical Study Reports
- Deliver project specific trainings
- Organise and participate in Monitor and Investigator Meetings
- Organise or take part in the periodic project update meetings
- Provide project updates to the Sponsor, Senior Project Manager and Project Director/Leader as required
- Inform the Project Director/Leader about any issues
- Perform co-monitoring visits for the assigned clinical projects as necessary
- Act as a tutor for Project Coordinators and Project Manager I
- 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
- Proven experience in clinical project management activities, 5 plus years in the CRO/pharmaceutical industry including previous experience as a CRA or similar
- 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 Benefits of Working for Cromsource in Italy
- Meal vouchers
- Mobile phone if requested by the Line Manager
- Dedicated Line Manager
- Monthly meetings with the 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 email. If you have the requirements we need, you will be invited for phone interview as the first step.
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.
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.
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