Clinical Study Manager
The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to manage clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.
We currently offer the exciting opportunity to join the team as Clinical Study Manager in full-time and work home-based in Italy. In this role you will be accountable for the operational and scientific oversight, the set-up, execution and delivery of your assigned clinical trials at the local level.
MAIN RESPONSIBILITIES
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Plans and leads execution of day-to-day activities for the monitoring of a complex clinical study and communicates consistently with the clinical team providing project objectives, expectations, and status updates.
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Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
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Provides Project Oversight & Leadership for Clinical Deliverables
- Leads and manages the clinical teams
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Leads and supports the relevant staff (ie. local start-up staff, local and global regulatory affairs staff, inhouse clinical staff, etc) to drive successful activation of trial sites
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Monitors the quality of clinical activities and addresses quality issues with the appropriate team member
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Reviews and approves site visit reports within agreed turnaround times and ensures tracking, follow up, and resolution of site issues
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Works with the relevant staff to identify data related issues and risks to clinical activities; develops contingency and mitigation plans to minimize risks
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Creates and maintains project-specific plans, documents, and tools for the clinical team
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Supports the CRAs with site monitoring activities and provides suggestions and solutions to site issues
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Oversees the relevant regulatory and in-house clinical staff to ensure that all non-safety periodic updates, progress reports, and renewals, and/or end of study notifications are performed in accordance with the trial protocol, local regulations, ICH GCP, and any other processes or procedures governing the clinical trial
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Acts as coordinating manager to ensure consistency of training, processes, and systems-related activities as well as ad-hoc coordinating activities
REQUIRED SKILLS AND QUALIFICATIONS
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Bachelor degree in related discipline, preferably in life science
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Five or more years of experience in clinical research, including a minimum of 4 years project management experience or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job
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Good knowledge of international guidelines ICH GCP as well as relevant local regulations
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Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality
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Previous work experience in TA's: Oncology or Onco-hematology is required
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Good knowledge of the Drug Development Process
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Excellent knowledge of spoken and written English and Italian language.
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Good ability to learn and to adapt to work with IT systems.
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Effective decision-making is crucial for resolving challenges and ensuring alignment with overall study goals.
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Experience in monitoring study activities for compliance and inspection readiness.
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Strong interpersonal skills are vital for collaborating with internal teams, stakeholders, and external vendors.
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A deep understanding of clinical operations processes, including trial data collection and management, is paramount to ensuring successful study execution.
- Location in Milan and Rome is preferred.
Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be