We are hiring an experienced Senior Clinical Project Manager, Italy - L to join our stellar team at CROMSOURCE in Italia.
Growing your career as a Full Time Senior Clinical Project Manager, Italy - L is an awesome opportunity to develop useful skills.
If you are strong in creativity, persuasion and have the right initiative for the job, then apply for the position of Senior Clinical Project Manager, Italy - L at CROMSOURCE today!
Description:
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
- 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
- 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
Benefits of working as a Senior Clinical Project Manager, Italy - L in Italia:
● Excellent benefits
● Opportunities to grow
● Advantageous package