Study Start-Up Manager
5 ore fa
Job Description Summary Novartis seeks a dynamic and experienced SSO Study Start‑Up Manager (SSUM) to join our dedicated team. This pivotal position reports directly to the Study Start‑Up (SSU) Team Lead and leads the local Study Start‑Up teams for designated trials holding significant responsibilities within our organization ranging from trial and budget planning to ensuring on‑schedule completion of trial start‑up activities. Job Description Key responsibilities The SSUM is responsible for study planning SSU processes and activation of assigned projects ensuring compliance with Novartis standards GCP / ICH guidelines and regulatory requirements. Your duties will but not be limited to Steering all SSUs of assigned projects in close cooperation with the SSO Feasibility Manager SSO Site Partnership Manager and the global study team. Backing the country’s SSU strategy working closely with the SSO Study Start‑Up Team Lead SSO SSU Country Head and SSO Country Head Portfolio (Early & Late Stage). Collaborating with the SSO Country Head Portfolio SSO Portfolio Team Leads and the global study team to ensure the SSU schedules and results meet country commitments. Responsible for timely startup activities from country allocation to the Green Light stage (ready to initiate site) in assigned projects. Facilitating close collaboration with local IRBs / IECs and Health Authorities where necessary. Ensuring efficient startup activities including overseeing the preparation of initial / amendments submission packages and consent form reviews. Coordinating timely responses to deficiency letters working closely with local and global partners. Responsible for the timely accurate and high‑quality country TMF documents ensuring readiness for inspection while adhering to financial standards prevailing legislation ICH / GCP guidelines local / National Health Authorities regulations and Novartis standards. Essential requirements A degree in a scientific / healthcare discipline with experience in clinical operations or project management. Minimum of 5 years experience in clinical operations in a project management role and / or in monitoring clinical trials. Skilled in leading in a matrix environment without direct reports. Understanding of all aspects of clinical drug development with a specific emphasis on trial set‑up execution and monitoring. Proven problem‑solving skills and ability to handle complex issues. Understanding of the international aspects of the drug development process including solid knowledge of international standards (GCP / ICH) Health Authorities (FDA / EMEA) local / National Health Authorities regulations and Novartis standards. Employment Type: Full‑Time Vacancy: 1 #J-18808-Ljbffr
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Study Start Up Manager
7 giorni fa
Milano, Italia AstraZeneca A tempo pieno**Study Start-up Manager** 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. The **Study Start-Up Manager (SSU Manager)** is responsible at country level for...
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Study Start-Up Manager
4 settimane fa
Milano, Italia Novartis A tempo pienoJob Description Summary Novartis seeks a dynamic and experienced SSO Study Start-Up Manager (SSUM) to join our dedicated team. This pivotal position reports directly to the Study Start-Up (SSU) Team Lead and leads the local Study Start-Up teams for designated trials holding significant responsibilities within our organization ranging from trial and budget...
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Study Start-Up Manager
4 settimane fa
Milano, Italia Novartis A tempo pienoJob Description Summary Novartis seeks a dynamic and experienced SSO Study Start-Up Manager (SSUM) to join our dedicated team. This pivotal position reports directly to the Study Start-Up (SSU) Team Lead and leads the local Study Start-Up teams for designated trials holding significant responsibilities within our organization ranging from trial and budget...
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Study Start-up Manager
5 giorni fa
Milano, Italia Novartis A tempo pieno**Summary**: Novartis seeks a dynamic and experienced SSO Study Start-Up Manager (SSUM) to join our dedicated team. This pivotal position reports directly to the Study Start-Up (SSU) Team Lead, and lead the local Study Start-Up teams for designated trials, holding significant responsibilities within our organization, ranging from trial and budget planning to...
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Study Start Up Associate
2 settimane fa
Milano, Italia ICON Plc A tempo pienoStudy Start Up Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Study Start Up Associate I to join our...
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Senior Study Start-Up Manager – Clinical Trials
4 settimane fa
Milano, Italia Novartis A tempo pienoA global healthcare company seeks an experienced SSO Study Start-Up Manager in Milan to lead trial start-up teams and ensure compliance with regulatory standards. The ideal candidate has a degree in a scientific discipline and at least 5 years of experience in clinical operations. Responsibilities include planning and executing trial processes, collaborating...
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Senior Study Start-Up Manager
4 settimane fa
Milano, Italia Novartis A tempo pienoA global healthcare company seeks an experienced SSO Study Start-Up Manager in Milan to lead trial start-up teams and ensure compliance with regulatory standards. The ideal candidate has a degree in a scientific discipline and at least 5 years of experience in clinical operations. Responsibilities include planning and executing trial processes, collaborating...
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Study Start Up Associate
1 settimana fa
Milano, Italia Icon plc A tempo pienoSite Activation Specialist 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...
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Sso Study Start-up Country Head
2 giorni fa
Milano, Italia Novartis A tempo pieno100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine -...
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Clinical Start Up Manager Milan
2 settimane fa
Milano, Italia Resourcing Life Science A tempo pieno**Company Description** Our client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a Clinical Start up Manager office based in Milan. **Job Overview** - Leading...
