Would you like to apply your expertise to make an impact in a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you!

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenge. Working here means being entrepreneurial, thinking big and teaming up to make impossible a reality.

Welcome to Basiglio (Milan), one of over 400 sites here at AstraZeneca. The site provides a collaborative environment where everyone feels comfortable and able to be themselves, which is at the core of AstraZeneca’s priorities.

As a global science-led biopharmaceutical company, everything we do comes back to improving the health of our patients worldwide. We seek out new opportunities to do dynamic and significant work, and we encourage our people to continually foster new insights to find different ways of building ground-breaking medicines. This is why, today, we have an unparalleled product portfolio in Oncology, Respiratory and Cardio-Renal Metabolic diseases.

As Local Study Manager you will lead Local Study Teams (LSTs) at country level to deliver clinical studies according to agreed resources, budget and timelines complying with AstraZeneca procedural documents, international guidelines as well as relevant local regulations.

If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us.

MAIN DUTIES AND RESPONSIBILITIES

The Local Study Manager is responsible to ensure that proper sites are identified and qualified to conduct global clinical studies, set up and initiated, monitored, closed and documentation archived.

In addition to leading LST(s), the Local Study Manager is expected to perform accompanied site monitoring visits with CRAs as well as to perform monitoring visits where required.

The role broadly includes the following key components:

• Overall responsibility for the study commitments within the country, for timely delivery of data to required quality as per SMA
• Lead Local Study Team(s) consisting of CRAs, start-up specialists and study administrator(s).
• In collaboration with Associate Director(s),

- Lead and optimise the performance of the Local Study Team(s) at country level ensuring compliance with AstraZeneca Procedural Documents, ICH-GCP and local regulations and to update other study team members on study matters

- Lead development of Local Monitoring Plan as per Targeted Monitoring guidance from respective Study Team.

- Perform any required co-monitoring & QC visits with study monitor(s)

• Contribute to review of monitoring visit reports and pro-actively advice the Monitor(s) on study related matters.
• Proactively identify and facilitate resolution of complex study problems and issues.
• Organise regular Local Study Team meetings on an agenda driven basis.
• Report study progress/update to the Study Leader/Team.
• Contribute to patient recruitment strategy with CRAs, including regular communication with concerned Investigators as necessary.
• Communicate and co-ordinate regularly with National Co-ordinating Investigator/National Lead Investigator on recruitment and other study matters.
• Coordinate the process for selection of potential Investigators considering capability, competence, etc, of the Hospitals/sites.
• Plan and lead national Investigator meetings, in line with local codes
• Assist in forecasting study timelines, resources, recruitment, budget, study materials and drugs.
• Work in close coordination with Study Drug Coordinator to create a robust Drug Consumption Plan.
• Ensure timely preparation of country SMA and country Master Clinical Study Agreement.
• In collaboration with the local study team, ensure completeness of documents on country and site level, and ensure essential documents are sent to relevant site.
• Facilitate translation of documents (ICFs, patient diaries, participation cards, etc) through external providers.
• In collaboration with the Start-up tea ensure timely submission of proper application/documents to Ethics Committees.
• Work together with Regulatory Affairs to ensure timely delivery of proper application/documents for submissions to Regulatory Authority.
• Set up and maintain the study in the Clinical Trial Management Systems, at study country level
• Ensure accurate payments related to the study are performed.
• Participate in training and coaching new members of the Local Study Team.
• Ensure that all study documents are ready for final archiving and sign-off.
• Plan and lead activities associated with audits and regulatory inspections in liaison with Line Manager, and Clinical Process Manager
• Provide input to process development and improvement
• Provide regular information to SMM Director/Associate Directors at country level on study/ies and planned study milestones/key issues
• Update SMM Director/ Associate Directors about the performance of the CRAs
• Managing all activities and Account relationship according with Company Values, Code of Conduct, Guidelines/Internal procedures and Italian legislation

ADDITIONAL RESPONSIBILITIES

• Assist SMM Director/ Associate Directors in efficient functioning of SMM department at country level.
• Prepare and maintain study budget at country level
• Liaise with Local Compliance Officer regarding payments to Investigators to ensure these are in accordance with local requirements
• Timely preparation and support to process of registration of applicable clinical studies in country-specific or regional websites
• Ensure that clinical and operational feasibility assessment of Study Design Concept and Clinical Study Protocol is performed to highest quality
• Support SMM region in initiatives as agreed with SMM Director/ Associate Directors

ESSENTIAL REQUIREMENTS

• University degree or equivalent, preferred in biological science or healthcare-related field
• Minimum 3 years-experience in Clinical Operations or other related fields (Medical Affairs-led studies or Academic-led studies)
• Fluent knowledge of spoken and written English and Italian
• Excellent knowledge of international guidelines - ICH-GCP
• Good knowledge of relevant local regulations
• Good medical knowledge in relevant AstraZeneca Therapeutic Areas
• Excellent knowledge in Clinical Operations and understanding of the Clinical Study Process
• Excellent knowledge/experience of the Monitoring Process
• Good understanding of the Study Drug Handling Process and Data Management Process
• Leadership capabilities
• Excellent project management and organisational skills

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application!

The recruitment team will evaluate your profile (qualifications, skills and experience), and review your CV to determine whether your skills and experience match the job profile.

Only shortlisted candidates matching the job profile will be contacted for an interview. If you are recently being involved into a recruitment process for a similar professional role within our Company, we will evaluate our previous feedback to arrange an interview.

Date Posted

28-lug-2021

Closing Date

15-ago-2021

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.