Local Study Manager - Italy - Home Based

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out at a country level in accordance with ICH-GCP and applicable local regulations. Maintain the quality and scientific integrity of clinical trials at a country level and Collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables within the country• Planning, management and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST)

The role:

• Accountable for study deliverables in that country.
• Leads country-level operational planning and supports site selection within region
• Ensure relevant systems are updated to enable accurate reporting of study progress and milestone deliverables
• Ensure key stakeholders are kept informed of study progress e.g. GCTM, DOM
• Contribute to development of study-specific materials – e.g. monitoring plan, study specific training documents.
• Provides input into the Country Operational Plan (COP) and partner with the DFM and GCTM to ensure regional delivery of the Global Study Operational Plan (GSOP)
• Support and contribute to Trial Management Teams (TMTs), agenda driven presence at meetings and daily huddle as required
• Communicate country status (including timelines and deliverables) to key stakeholders (e.g. TMT, GCTM, Program Managers) and ensures updates to relevant systems
• Contributes to site-level goal setting and study-specific deliverables for clinical sites within their country
• Coordinates cross-functional review of issues escalated directly from sites or via the CRA and facilitates resolution
• Oversight and monitoring of applicable vendor activities eg. laboratories and equipment provisioning
• Monitor the execution of the clinical study against timelines, deliverables and budget for that country
• Monitor country enrolment and retention and act on deviations from plan. Identify barriers to enrolment and support recruitment and retention strategic solutions.
• Monitor and act upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate
• Monitor and review country/regional trends
• Contribute to the study-level forecast for investigational product, support study level accountability and reconciliation across multiple countries, management of ELE process
• Identify and facilitate resolution of cross-functional study-specific issues
• Provide updates regarding the study budget and obtain approval for budget deviations for clinical sites (outside of range)
• Escalate any issues related to delivery, timelines or budget to GCTM or TMT lead if appropriate
• Execute regulatory agency inspection readiness activities (e.g. TMF review, story board generation)
• Participate in cross-functional task forces/process improvement groups
• Assign and oversee deliverables of study support staff e.g. Study Management Associate, CTS
• Member of the Global Clinical Studies Team (GCST)

To be successful in the role, you will have:

• BA/BS/BSc
• 4 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)
• Advanced knowledge of global clinical trial management
• Clinical trial processes and operations
• Extensive knowledge of ICH/GCP regulations and guidelines

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

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