Study Start Up Manager

hace 8 meses

Buenos Aires, Argentina Bristol Myers Squibb A tiempo completo

En Bristol Myers Squibb, nos inspira una sola visión: transformar la vida de los pacientes a través de la ciencia. En oncología, hematología, inmunología y enfermedades cardiovasculares, y una de las líneas de producción más diversas y prometedoras de la industria, cada uno de nuestros apasionados compañeros contribuye a innovaciones que impulsan cambios significativos. Aportamos un toque humano a cada tratamiento en el que somos pioneros. Únete a nosotros y marca la diferencia.

Purpose/Objective of the job
- Responsible for activities related to study start up and ongoing study document management
- Act as point of contact for local study teams and external stakeholders

Key Responsibilities and Major Duties
- Independently manages multiple country, study and site level deliverables during start-up and maintenance both within BMS and external business partners and vendors, when required.
- Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trial milestones
- Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents
- Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission.
- Prepare and perform submissions for Ethics Committees including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission).
- Collaborates with other internal roles in country feasibility and site selection.
- Collaborates directly with the BMS internal study teams, external site staff, country ethics committees/IRB to ensure tasks and priorities are aligned to the defined study timelines
- Prepare country Informed Consent Form (ICF) and manage country ICF template
- Review translation and customize with requistes to obtain Site ICFs
- Review and approval of Clinical Trial Package (CTP) documentation
- Update national registries as applicable
- Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management
- When applicable, conduct drug/IMP label review & translation
- Serves as expert on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and legal
- May support the collection and distribution of documents from / to sites including obtaining insurance certificates
- May support Health Authority inspection and pre-inspection activities
- May support audit preparation & Corrective Action / Preventative Action preparation for local related issues Senior Level Expectations:

- Serves as an SME for key investigational sites. Documents and maintains relevant information on the site’s structure, start-up processes, key contacts, etc (i.e., Site Playbook) for sharing with internal team members.
- Represents BMS in local (e.g. pharma association or HA driven) working groups around start up processes in the country
- Represents BMS in meetings discussing local requirements / repetitive questions from local Health Authority and Ethics Committees
- Proactively works with stakeholders (e.g. document template owners, GRS, CMC, CSO) to prevent questions from HA based on observed past questions.
- Constantly analyze the SSU process, looking for innovative ways to introduce efficiencies in order to speed-up start-up timelines, whilst maintaining quality.

**Requirements**:

- Bachelor's degree required preferably within life sciences or equivalent
- 5 years or more of industry related experience that includes significant experience in coordination of trial start-up activities and support to Health Authority / Ethic Committee submissions
- Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
- Thorough understanding of GCP, ICH Guidelines and Country regulatory environment
- In depth knowledge and understanding of clinical research processes, regulations and methodology
- Demonstrated organizational and planning skills and independent decision-making ability
- Strong organization and time management skills and ability to effectively manage multiple competing priorities
- Ability of critical thinking and risk analysis.
- Good verbal and written communication skills (both in English and local language)
- Knowledge of: Microsoft Suite / Clinical Trial Management Systems(CTMS) / Electronic Trial Master File (eTMF) / Document exchange portals

LI-hybrid

En todo el mundo, nos apasiona tener un impacto en la vida de los pacientes con enfermedades graves. Con el poder de aplicar nuestros talentos individuales y perspectivas diversas en una cultura incl

  • Sso Study Start-up Manager

    hace 7 meses

    Buenos Aires, Argentina Novartis A tiempo completo

    390776BR **SSO Study Start-Up Manager**: Argentina **About the role** 100,000. That’s how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients’ lives every day acting as a link between science and medicine. Envision the impact you could have! #GCO The SSO Study Start-Up Manager is...

  • Study Start Up Manager

    hace 8 meses

    Buenos Aires, Argentina Bristol Myers Squibb A tiempo completo

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Associate Study Start-up Manager, Argentina

    hace 7 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Unleash Your Potential It takes curiosity and intellectual courage to accomplish great things. It takes brave minds to bring powerful ideas to reality and transform healthcare. We are a diverse, global team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward. Join IQVIA and see where...

  • Study Start Up Associate I

    hace 1 semana

    Buenos Aires, Argentina Icon plc A tiempo completo

    Study Start Up Associate I JR093872 Site: Buenos Aires - Argentina At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and...

  • Study Start Up Lead

    hace 7 meses

    Buenos Aires, Argentina Novo Nordisk A tiempo completo

    Study Start up Lead **Category**:Clinical Development**Location**:Vicente Lopez, Buenos Aires, AR- Are you ready for a life-changing career at Novo Nordisk Argentina? Join us.- Working at Novo Nordisk is never just a job, it is an opportunity to have a life-changing career - you grow professionally.**The Position**Activities and Responsibilities** -...

  • Start-up Specialist

    hace 3 semanas

    Buenos Aires, Argentina Labcorp A tiempo completo

    Role Description Study-Start-Up/QC Specialist: Purpose: Study Start Up/QC Specialist is responsible for country study start up (SSU) activities and performing quality review of essential documents. The SSU/QC Specialist is responsible for overseeing and leading SSU activities in collaboration with country team members (CLM and CRA) with the objective to...

  • Study Start Up Associate I

    hace 7 meses

    Buenos Aires, Argentina ICON A tiempo completo

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing...

  • Study Start-up Manager, Argentina

    hace 7 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Unleash Your Potential It takes curiosity and intellectual courage to accomplish great things. It takes brave minds to bring powerful ideas to reality and transform healthcare. We are a diverse, global team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward. Join IQVIA and see where...

  • Senior Start-up Specialist

    hace 1 semana

    Buenos Aires, Argentina Labcorp A tiempo completo

    Provide expertise for local regulations, ICH/GCP and relevant study and Sponsor requirements.  When delegated by Start-up Country Manager (SUCM), oversee and ensure quality data and audit readiness.  Anticipate and prevent issues and service failures from developing in their study, escalating when appropriate, negotiating when required.  Ensure...

  • Study Start Up Associate Ii

    hace 7 meses

    Buenos Aires, Argentina ICON A tiempo completo

    Job Advert Posting At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by...

  • Study Start Up Associate Ii

    hace 7 meses

    Buenos Aires, Argentina ICON plc A tiempo completo

    Job Advert Posting At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by...

  • Study Start Up Associate

    hace 7 meses

    Buenos Aires, Argentina ICON plc A tiempo completo

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing...

  • Study Start Up Associate I

    hace 3 semanas

    Buenos Aires, Argentina ICON A tiempo completo

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • Study Start Up Associate I

    hace 7 meses

    Buenos Aires, Argentina ICON plc A tiempo completo

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing...

  • Country Study Operations Manager

    hace 9 meses

    Buenos Aires, Argentina Pfizer A tiempo completo

    The Country Study Operations Manager (cSOM) is responsible for regional/country level activities from study startup through conduct and study close. The cSOM will be assigned one or more studies and will be tasked with taking on several responsibilities in support of the larger Study Management deliverables. The cSOM partners with the Global Study Manager,...

  • Study Start Up Associate I/ii/sr

    hace 7 meses

    Buenos Aires, Argentina Icon plc A tiempo completo

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • Study Start Up Associate I

    hace 4 meses

    Buenos Aires, Argentina Icon plc A tiempo completo

    Study Start Up Associate I (Regulatory Submissions) - Argentina - Hybrid Scheme 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 At ICON, it’s...

  • Senior Study Start Up Associate

    hace 7 meses

    Buenos Aires, Argentina ICON A tiempo completo

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing...

  • Start-up Associate

    hace 1 semana

    Buenos Aires, Argentina Labcorp A tiempo completo

    Trial and site administration: - Tracking (e.g. essential documents) and reporting (e.g. Safety Reports) - Ensure collation and distribution of study tools and documents - Update clinical trial databases (CTMS) and trackers - Clinical supply & non-clinical supply management, in collaboration with other country roles - Manage Labeling requirements and...

  • Start Up Specialist

    hace 1 semana

    Buenos Aires, Argentina Labcorp A tiempo completo

     Serve as local expert in project start-up activities for a particular country or region.  Act as a ‘knowledge resource’ to mentor and train new hires and less-experienced department colleagues. Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and...