17 publicaciones de empleo destacadas en senior java engineer remote, within eu (¡Están contratando!)

Site Readiness and Regulatory Specialist I
Fortrea —Buenos Aires, Buenos Aires
- Tiempo completo
Strategy & Execution Manager
FeverUp —Capital Federal, Buenos Aires
Postulación rápida
Senior Salesforce Platform Architect
サイネオス・ヘルス —Buenos Aires, Buenos Aires
Regulatory Affairs Officer, IQVIA Biotech
IQVIA —Buenos Aires, Buenos Aires
- Tiempo completo
2d
Strategic Event Operations Manager - Buenos Aires
FeverUp —Capital Federal, Buenos Aires
Postulación rápida
9d
R/SAS Statistical Programmer (hiring in Armenia, Hungary, Estonia, CR, Romania, Argentina, Brazil, or Columbia only)
サイネオス・ヘルス —Buenos Aires, Buenos Aires
Sr Tech Customer Success Analyst
サイネオス・ヘルス —Buenos Aires, Buenos Aires
13d
Operations Strategy Manager (Global Events)
FeverUp —Capital Federal, Buenos Aires
Postulación rápida
Digital Creative Lead
FeverUp —Buenos Aires, Buenos Aires
Postulación rápida
Growth Strategy Associate
FeverUp —Capital Federal, Buenos Aires
Postulación rápida
Growth Strategy Analyst
FeverUp —Capital Federal, Buenos Aires
Postulación rápida
Principal, Tech Custmr Success
サイネオス・ヘルス —Buenos Aires, Buenos Aires
Growth Strategy Manager
FeverUp —Buenos Aires, Buenos Aires
Postulación rápida
9d
Sr Clinical Development Operations Analyst (Client Engagement). Based in Serbia or Argentina
サイネオス・ヘルス —Buenos Aires, Buenos Aires
Site Contracts Specialist with clinical trials experience Home-Based in Argentina
サイネオス・ヘルス —Buenos Aires, Buenos Aires
3d
Performance Marketing Specialist, Mobile
Blockchain.com —Buenos Aires, Buenos Aires
Postulación rápida
Media Manager (Traditional Media)
FeverUp —Capital Federal, Buenos Aires
Postulación rápida
14d

Other jobs to consider

Find your next job by exploring related positions.

Front End Engineer - Remote
EventMobi —Buenos Aires, Buenos Aires
Work closely with product managers, designers, and senior engineers. Contribute to features within our Progressive Web App. Collaborate and Improve as a Team.
Technical Product Engineer - 100% Remote
Progressive Automations —Desde casa
Diploma/Degree in Electronics, Mechanical or Mechatronics Engineering or equivalent. Ability to stay calm and de-escalate when customers are stressed or upset.
Postulación rápida

Quiero recibir la alerta de empleo más reciente para senior java engineer remote, within eu

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

Site Readiness and Regulatory Specialist I

Fortrea -
Buenos Aires, Buenos Aires

Postulate ahora

Detalles del empleo

Tiempo completo

Descripción completa del empleo

Job Overview:

Primary contact with investigative sites during study maintenance and -when assigned-, site startup activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the timelines agreed with project management and Site Readiness team. Develop awareness of regulatory legislation, guidance, and practice in the assigned countries with the support from senior staff.

Summary of Responsibilities:

Develop awareness of regulatory legislation, guidance, and practice in the assigned countries with the support from senior staff.
Assist senior staff to compile, prepare, submit, and obtain approval of the submission documents to IRB/IEC/Third body/Regulatory Authority in accordance with local requirements.
Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).
Perform a review of final submission documents as applicable.
Organize communication related to the submissions/outcomes within Fortrea as applicable.
Escalate study issues appropriately and in a timely fashion.
Perform other duties as assigned by management depending upon country and situational requirements with proper supervision (if applicable).
In Country specific tasks (Global):
Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
Collect and track all the necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance.
Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines.
Update study documents when there are changes in study personnel/study amendments.
Ensure high quality documents are filed and systems are updated on an ongoing and timely basis, making Fortrea ready for an audit at any time.
Update status reports, applicable logs, and tracking systems as applicable for the projects with input provided by senior staff.
With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements.
May support / assist the contract negotiation process under supervision of an experienced colleague or line manager.
Proactively identifying and escalating to Submission Leads any risk to meeting deliverables.
Notify the Submissions Lead of hours identified as Out-of-Scope or over burn with the support of more senior specialists.
All other duties as needed or assigned.
Clinical Trials Information System (CTIS) tasks (specific centralized role for EU):
Upload of submission documentation to CTIS under supervision as applicable.

Qualifications (Minimum Required):

University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology).
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

Minimum 0 – 2 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines
Demonstrated basic understanding of the clinical trial process.

Physical Demands/Work Environment:

General Office Environment.

Learn more about our EEO & Accommodations request here .

Postulate ahora

Refiná tu búsqueda

senior java engineer remote, within eu empleos

Site Readiness and Regulatory Specialist I

Strategy & Execution Manager

Senior Salesforce Platform Architect

Regulatory Affairs Officer, IQVIA Biotech

Strategic Event Operations Manager - Buenos Aires

R/SAS Statistical Programmer (hiring in Armenia, Hungary, Estonia, CR, Romania, Argentina, Brazil, or Columbia only)

Sr Tech Customer Success Analyst

Operations Strategy Manager (Global Events)

Digital Creative Lead

Growth Strategy Associate

Growth Strategy Analyst

Principal, Tech Custmr Success

Growth Strategy Manager

Sr Clinical Development Operations Analyst (Client Engagement). Based in Serbia or Argentina

Site Contracts Specialist with clinical trials experience Home-Based in Argentina

Performance Marketing Specialist, Mobile

Media Manager (Traditional Media)

Other jobs to consider

Quiero recibir la alerta de empleo más reciente para senior java engineer remote, within eu

Related Searches

Herramientas para candidatos

Herramientas para empresas

Explorar

Mantente conectado