Senior Clinical Project Manager - Italy

I’m partnered with a global CRO who is looking for a Senior Clinical Project Manager based in Italy.

The Senior CPM will act as a matrix leader for the global clinical operations team under the supervision of the Clinical Operations Manager and will be accountable for the timely execution of specific tasks within the protocols.

Responsibilities:

• Conduct feasibility, pre-study visits, site initiation visits, monitoring visits and/or close out visits as necessary
• Ensure that the monitoring team is trained on study specific procedures and aspects
• Coordinate and oversee project activities
• Manage the vendors involved in the study
• Ensure that the monitoring activities are conducted as well as regularly reviewing the activity of monitoring, remote monitoring, contact and telephone contact reports
• Update and check the Trial Master File (TMF) of the studies within Switzerland as well as ensuring that the site TMF are checked by the monitoring team according to CRO and Sponsor procedures

• Coordinate and oversee project activities
• Organize project activities and evaluate timeframes
• Manage the administrative aspects of studies
• Manage study materials (re-supply/drug expiration/re-labelling of drugs, various materials)
• Prepare study specific procedures and tools (if applicable)
• Prepare feasibility questionnaires (if applicable)
• Manage the vendors involved in the study
• Review and approve the Investigator’s Folder and Trial Master File prototype
• Verify compliance with operating procedures
• Ensure that the monitoring activities are conducted as per monitoring plan requirements
• Review monitoring, remote monitoring, contact and telephone contact reports
• Send regular updates to the Sponsor
• Ensure that the enrollment curve is on track and take actions in case of under-performance
• Check compliance with timeframes, quality and contractual requirements
• Propose and guarantee the implementation of action plans that resolve issues and/or improve processes
• Properly and timely escalate relevant issues to his/her direct superior and to the Clinical Team (if applicable)
• Update/check the Trial Master File of the studies (country) according to CRO and/or Sponsor procedures
• Ensure that the site TMF are checked by the monitoring team according to CRO and/or Sponsor procedures
• Keep track of terminating studies and do the final check of the completeness of TMFs
• Maintain contacts with clinical staff as necessary
• Manage relationships with Data Centers
• Perform co-monitoring visits with CRAs, if necessary
• Coordinate/participate in Investigator’s Meeting, Monitor’s Meeting and project meetings
• Participate in periodic meetings held by the Sponsor to plan activities
• Plan and hold study specific meetings with CRAs, as necessary
• Ensure that the monitoring team is trained on study specific procedures and aspects
• May act as Clinical Project Leader for international projects
• Collaborate to on-boarding of new associates and act as a mentor of junior staff
• Collaborate in establishing and maintaining SOPs related to Clinical Operations Unit
• Enter all the information required in the TRACK system on an ongoing basis

Moreover, the Senior Clinical Project Manager can conduct Feasibility, Pre-study Visit, Site Initiation Visit, Monitoring Visit or Close out visit as necessary (e.g. back-up or directly allocated to the site) if the CPM is compliant with local minimum requirements for monitoring.

Requirements

• Degree in a scientific field
• In depth knowledge of GCP and techniques for the monitoring of clinical trials
• At least 5 years working as a Clinical Project Manager
• Fluent in English and Italian
• Able to coordinate all the activities related to the management of local and international projects including managing interventional clinical trials, monitoring of clinical trials, and guaranteeing the security of information; preferably in CRO environment
• Work independently under the supervision of the Head of Clinical Operations Unit and Clinical Operations Manager
• Ability to interact with personnel properly and to manage the monitoring activities of CRAs (if required)

If you are interested in discussing this role in further detail, please don’t hesitate to apply or reach out to me: Roxanna.keshavarz@rbwconsulting.com / +44 1273 952187