17 publicaciones de empleo destacadas de associate manager, customer supply en buenos aires, b (¡Están contratando!)

Local Study Associate Director - FSP
Parexel —Buenos Aires, Buenos Aires
Senior - Cloud Platform Engineer
PwC —Buenos Aires, Buenos Aires
- Tiempo completo
Clinical Supply Chain Manager ** open to several EMEA & LATAM countries (Homebased) **
サイネオス・ヘルス —Buenos Aires, Buenos Aires
8d
Chef Corporativo - Buenos Aires, Argentina
Minor Hotels Europe & Americas —Buenos Aires, Buenos Aires
Postulación rápida
Dynamics 365 CRM & ERP + Jira IT Project Manager PTE
ITC WORLDWIDE —Buenos Aires, Buenos Aires
Postulación rápida
Sr CRA I
Fortrea —Buenos Aires, Buenos Aires
- Tiempo completo
Senior Frontend Engineer
Canals —Buenos Aires, Buenos Aires
- Tiempo completo
Client Services Associate - Software - Tax Solutions
S&P Global —Buenos Aires, Buenos Aires
Senior - Auditoria Externa Contable
PwC —Buenos Aires, Buenos Aires
- Tiempo completo
Sales Analyst – Commercial Insights (Argentina & Chile)
Energizer —Martínez, Buenos Aires
- $16.404.200 - $44.006.800 por año
- Tiempo completo
Postulación rápida
2d
Junior Software Engineer
Canals —Buenos Aires, Buenos Aires
- Tiempo completo
E-Commerce Inventory Recovery and Unfulfillable Specialist (Amazon)
Lago —Buenos Aires, Buenos Aires
- Tiempo completo
Postulación rápida
Senior Software Engineer - Argentina
Canals —Buenos Aires, Buenos Aires
- Tiempo completo
Senior Cloud Engineer - DevOps & DevSecOps (English)
BETSOL —Buenos Aires, Buenos Aires
- Tiempo completo
Postulación rápida
IBM Guardium Engineer
Insside Ciberseguridad —Buenos Aires, Buenos Aires
- Tiempo completo
Postulación rápida
3d
Clinical Trial Assistance (Administrative) - Buenos Aires
サイネオス・ヘルス —Buenos Aires, Buenos Aires
Analista de atención al cliente I
Avient —Lomas de Zamora, Buenos Aires
- Tiempo completo
Postulación rápida
1d

More jobs to discover

Find similar jobs that you might be interested in.

Senior - Cloud Platform Engineer
PwC —Buenos Aires, Buenos Aires
Diseñar, construir y mantener infraestructura basada en Azure utilizando módulos de Terraform (recursos IaaS y PaaS), tanto para nuevos proyectos como para…
1001 - Platform Engineer · Senior · Remoto · LATAM
Darwoft —Buenos Aires, Buenos Aires
Colaborar con equipos de desarrollo, DevOps, arquitectura, seguridad y producto. Cualquier actividad profesional adicional deberá ser informada previamente y no…
Postulación rápida
14d

Quiero recibir la alerta de empleo más reciente para associate manager, customer supply en buenos aires, b

Al ingresar a tu cuenta, aceptas las Condiciones del servicio de SimplyHired y das tu consentimiento a nuestra Política de privacidad y Cookies.

Local Study Associate Director - FSP

Parexel -
Buenos Aires, Buenos Aires

Postulate ahora

Detalles del empleo

Descripción completa del empleo

The Local Study Associate Director (LSAD) leads Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.

The LSAD may perform site monitoring as needed to support the flexible capacity model.

The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

Trial and Site Administration

Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies.
Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with client Procedural Documents, ICH-GCP and local regulations.
Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
Plans and coordinates applicable to local drug activities (from local purchase or reimbursement to drug destruction).
Sets up and maintains the study in CTMS at study country level and local websites as required by local laws and regulations.
Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
Reviews monitoring visit reports (as required and following Client SOPs) and pro-actively advises the monitor(s) on study related matters.
Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
Proactively identifies risks and facilitates resolution of complex study problems and issues.
Organizes regular Local Study Team meetings on an agenda driven basis.
Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders.
Reports study progress/update to the Global Study Associate Director/ Global Study Team including Site Management and Monitoring (SMM) Lead.
Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
Develops, maintains and reviews risk management plans on country study level; proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.
Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
Plans and leads National Investigator meetings, in line with local codes, as required.
Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and client Procedural Documents.
Plans and leads activities associated with audits and regulatory inspections in liaison with Clinical Quality Associate Director (CQAD) and QA.
Provides input to process development and improvement.
Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.
Updates Line Managers about the performance of the CRAs/CSAs.
Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
Collaborates with local Medical Affairs team.
Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management

Document Management

Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant client SOPs and local regulations.
Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with Client SOPs.
Ensures completeness of the eTMF and ensures essential documents are uploaded in a timely manner to maintain the eTMF “Inspection Ready”.
Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.

Regulatory and Site Start Up Responsibilities

Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organized at country level.

Budgeting, Agreements and Payments

Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in client clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head).
Ensures timely preparation of local Master Clinical Study Agreement (CSA) (including site budget) and amendments as needed.
Ensures accurate payments related to the study are performed according to local regulations and agreements.

Skills (Essential):

Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
Excellent project management skills.
Excellent team building and interpersonal skills.
Excellent organizational skills.
Excellent verbal and written communication skills.
Excellent ability to prioritize and handle multiple tasks.
Excellent attention to detail.
Proficient in written and spoken English language required.
Fluency in local language(s) required.
Good negotiation skills.
Good ability to learn and to adapt to work with IT systems.

Knowledge and Experience (Essential):

Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).
Good knowledge of international guidelines ICH GCP as well as relevant local regulations.

Knowledge and Experience (Desirable):

Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
Good knowledge of the Drug Development Process.
Excellent understanding of the Clinical Study Process including monitoring.
Very good understanding of the Study Drug Handling Process and the Data Management Process.
Good intercultural awareness.

Education:

Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.

#LI-REMOTE

Postulate ahora

Refiná tu búsqueda

associate manager, customer supply empleos en buenos aires, b

Local Study Associate Director - FSP

Senior - Cloud Platform Engineer

Clinical Supply Chain Manager open to several EMEA & LATAM countries (Homebased)

Chef Corporativo - Buenos Aires, Argentina

Dynamics 365 CRM & ERP + Jira IT Project Manager PTE

Sr CRA I

Senior Frontend Engineer

Client Services Associate - Software - Tax Solutions

Senior - Auditoria Externa Contable

Sales Analyst – Commercial Insights (Argentina & Chile)

Junior Software Engineer

E-Commerce Inventory Recovery and Unfulfillable Specialist (Amazon)

Senior Software Engineer - Argentina

Senior Cloud Engineer - DevOps & DevSecOps (English)

IBM Guardium Engineer

Clinical Trial Assistance (Administrative) - Buenos Aires

Analista de atención al cliente I

More jobs to discover

Quiero recibir la alerta de empleo más reciente para associate manager, customer supply en buenos aires, b

Related Searches

Herramientas para candidatos

Herramientas para empresas

Explorar

Mantente conectado