Local Study Associate Director Oncology

2 settimane fa

Milano, Italia AstraZeneca A tempo pieno

**Local Study Associate Director Oncology**

At AstraZeneca, we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve, no matter where you start with us.

Welcome to MIND (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 Associate Director **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 Associate Director 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 Associate Director 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 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.
- 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 at country level on study/ies and planned study milestones/key issues
- Update SMM Senior Director Oncology Lead/ 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 in efficient functioning of SMM department at country level.
- Prepare and maintain study budget at country level
- Liaise with Local Compliance Officer regar

  • Clinical Research Associate Oncology

    4 settimane fa

    Milano, Italia AstraZeneca A tempo pieno

    At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. As a **Clinical Research Associate (CRA)** in Italy, you will play a pivotal role in channelling our scientific...

  • Associate Director

    4 settimane fa

    Milano, Italia Willis Towers Watson A tempo pieno

    Associate Director - Milano, IT June 13, 2023 **ASSOCIATE DIRECTOR** **(SENIOR BUSINESS CONSULTANT LEAD)** In WTW we provide data-driven, insight-led solutions in the areas of people, risk and capital. Leveraging the global view and local expertise of our colleagues serving 140 countries and markets, we help to sharpen the strategy, enhance...

  • Associate Director

    2 settimane fa

    Milano, Italia Willis Towers Watson A tempo pieno

    We are on the lookout for a resourceful Associate Director to join our awesome team at Willis Towers Watson in Milano. Growing your career as a Full Time Associate Director is an incredible opportunity to develop useful skills. If you are strong in teamwork, critical thinking and have the right initiative for the job, then apply for the position of Associate...

  • Country Head of Oncology

    4 settimane fa

    Milano, Italia AstraZeneca A tempo pieno

    **About AstraZeneca Oncology Business Unit** At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality We’re all here to make an impact - to achieve our bold ambition of eliminating cancer as a cause of death. In the...

  • Clinical Research Associate Ii

    3 giorni fa

    Milano, Italia Psi A tempo pieno

    Job DescriptionAs a Clinical Research Associate at PSI Italy you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.Hybrid working arrangement in Milan area or homebased in other regions of ItalyResponsibilities:Conduct and report all types of...

  • Clinical Research Associate Ii

    3 giorni fa

    Milano, Italia Psi Cro A tempo pieno

    Job Description As a  Clinical Research Associate  at PSI Italy you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry. Hybrid working arrangement in Milan area or homebased in other regions of Italy Responsibilities: Conduct and report all...

  • Associate Director

    4 settimane fa

    Milano, Italia WTW A tempo pieno

    **ASSOCIATE DIRECTOR** **(SENIOR BUSINESS CONSULTANT LEAD)** In WTW we provide data-driven, insight-led solutions in the areas of people, risk and capital. Leveraging the global view and local expertise of our colleagues serving 140 countries and markets, we help to sharpen the strategy, enhance organizational resilience, motivate workforce and maximize...

  • Cra I

    4 settimane fa

    Milano, Italia Meet Recruitment A tempo pieno

    Competitive - Milan, Italy - Permanent **CRA I / II - Oncology focus - Global CRO** **Work model: Remote** **Locations: Italy** Are you willing to take your career to the next level in a market-leading global CRO, with a wider range of projects to learn from? As a CRA I or II, you could be looking to broaden your therapeutic, geographic, and study...

  • Clinical Research Associate Ii

    1 giorno fa

    Milano, Italia Psi Cro A tempo pieno

    PSI is a leading Contract Research Organization with more than 28 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description As a  Clinical Research Associate  at PSI Italy you will enjoy...

  • Associate Director

    4 settimane fa

    Milano, Italia WTW A tempo pieno

    **The Role** **ASSOCIATE DIRECTOR** We know how companies can unlock potential through effective risk management. Our clients rely on us to craft strategies to quantify, mitigate, and transfer risk, taking advantage of our specialist industry experience and unparalleled market know-how. The result is a new way of embracing risk that drives superior...

  • associate director

    2 settimane fa

    Milano, Lombardia, Italia WTW A tempo pieno

    The RoleASSOCIATE DIRECTORWe know how companies can unlock potential through effective risk management. Our clients rely on us to craft strategies to quantify, mitigate, and transfer risk, taking advantage of our specialist industry experience and unparalleled market know-how. The result is a new way of embracing risk that drives superior results.Responsible...

  • Associate Director

    2 settimane fa

    Milano, Italia Willis Towers Watson A tempo pieno

    The Role ASSOCIATE DIRECTOR We know how companies can unlock potential through effective risk management. Our clients rely on us to craft strategies to quantify, mitigate, and transfer risk, taking advantage of our specialist industry experience and unparalleled market know-how. The result is a new way of embracing risk that drives superior results....

  • Medical Evidence Advisor Oncology

    4 settimane fa

    Milano, Italia AstraZeneca A tempo pieno

    **Medical Evidence Advisor Oncology** At AstraZeneca we believe in the potential of our people, and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. Welcome to **MIND (Milan),** one of over 400 sites here at AstraZeneca....

  • Clinical Research Associate

    4 settimane fa

    Milano, Italia Excelya A tempo pieno

    Excelya is one of the leading CROs in Europe, founded in 2014 and headquartered in Paris. Our global team is composed of 900+ experts who understand the critical needs of clients and provide trial solutions across a broad spectrum of therapeutic areas. We take a one-team approach to work: our shared success is the result of collaboration at every stage of a...

  • Associate Director, Human Resources Italy

    4 settimane fa

    Milano, Italia Incyte Corporation A tempo pieno

    Overview: **Incyte Italy** has experienced significant growth as we strengthen our impact in hematology-oncology and establish a strong foothold in Dermatology. To maximize our ability to SolveOn, we are creating a new position in the Italian organization as Associate Director Human Resource to support the Italian team in its development and growth...

  • Project Director

    4 settimane fa

    Milano, Italia Turner & Townsend A tempo pieno

    Company Description At Turner & Townsend we’re passionate about making the difference. That means delivering better outcomes for our clients, helping our people to realize their potential, and doing our part to create a prosperous society. Every day we help our major global clients deliver ambitious and highly technical projects, in over 110 offices...

  • Study Coordinator

    4 settimane fa

    Milano, Italia Ospedale San Raffaele srl A tempo pieno

    L'IRCCS Ospedale San Raffaele, struttura clinica-scientifica-universitaria di rilievo internazionale e di alta specializzazione per diverse importanti patologie, sta ricercando uno/a Study Coordinator da inserire nel team sperimentale del Centro di Ricerca Cardiovascolare a supporto di un progetto ministeriale pluriennale sulla prevenzione cardiovascolare,...

  • Associate Director

    3 settimane fa

    Milano, Italia Currie & Brown Group Limited A tempo pieno

    Currie & Brown is one of the leading international physical asset management and construction consultancies, dedicated to advising clients worldwide with our expertise and experience in multiple sectors and services. We are differentiated by our people, innovation and reputation with a genuine global office network. Our people, from the first-day apprentice...

  • Associate Director

    3 settimane fa

    Milano, Italia Currie & Brown Group Limited A tempo pieno

    Currie & Brown is one of the leading international physical asset management and construction consultancies, dedicated to advising clients worldwide with our expertise and experience in multiple sectors and services. We are differentiated by our people, innovation and reputation with a genuine global office network. Our people, from the first-day...

  • Associate Director, Human Resources Italy

    3 settimane fa

    Milano, Italia Incyte Corporation A tempo pieno

    The Drive to Discover. The Experience to Deliver. Share with friends or Subscribe! Looking for a challenge and a chance to grow your career? Then Incyte is the pharmaceutical company for you. While our pipeline demonstrates the ability to compete with much larger pharmaceutical companies in selecting compelling targets and creating high-quality drug...