Description:**Location**: EU - Home based**Schedule**: Full Time, PermanentAre 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 sponsors in the EU, one of the most innovative pharmaceutical companies in the world.**Main Job Tasks and Responsibilities**:- Manages the development and planning of clinical projects,
interacting with the Sponsor and the Investigators and coordinating the project team members- 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 the 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 FeasibilityAssociate (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**:- University Degree in scientific, medical, or paramedical disciplines- Significant 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.G. Word, Excel, Outlook)- Willingness to travel**Our benefits when working 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 improvementThe Application ProcessWho will you be working for?About CROMSOURCE- CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, 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.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 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: 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.**Skills**:Clinical Project Manager, Clinical Trial Manager, clinical trials, CRO, Out
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