Senior Study Start Up Specialist, Iqvia Biotech

hace 17 horas

Rosario, Argentina IQVIA A tiempo completo

Rosario, Argentina | Full time | Home-based | R1505002

Job available in additional locations

Job Overview
Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions
- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
- Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
- Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.

**Qualifications**:

- Bachelor's Degree Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
- 3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience.
- In-depth knowledge of clinical systems, procedures, and corporate standards.
- Good negotiating and communication skills with ability to challenge, if applicable.
- Effective communication, organizational, and interpersonal skills.
- Ability to work independently and to effectively prioritize tasks.
- Ability to manage multiple projects.
- Knowledge of applicable regulatory requirements, including local regulations,, SOPs and company’s Corporate Standards.
- Understanding of regulated clinical trial environment and knowledge of drug development process.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.

  • Research and Development Manager

    hace 1 semana

    Rosario, Argentina Nuestras A tiempo completo

    We are hiring Research and Development Manager - Seeds and Biotech Traits to join the Bioceres Seeds team! The position will Lead the R&D team, and manage R&D activities globally, in order to develop new products and technologies in seeds and biotech traits, while optimizing process and bringing innovation. **Crops**: Row crops in general, with main focus...

  • Remote Travel Specialist: Create Seamless Journeys

    hace 4 horas

    Rosario, Argentina Hjbtravels A tiempo completo

    A global travel agency is seeking a Remote Travel Specialist to help clients navigate their travel experiences from planning to return. This role requires excellent communication skills and a background in customer service. Responsibilities include responding to client inquiries, assisting with travel modifications, and providing up-to-date destination...

  • Technical Support Specialist

    hace 3 semanas

    Rosario, Argentina StratifyIQ A tiempo completo

    Job Summary : Join our team as a Technical Support Specialist, providing exceptional remote support. You'll review and update support tickets, troubleshoot issues, and ensure prompt resolutions while documenting processes. Ideal candidates have technical support experience, excellent communication skills, and proficiency with CRM / ticketing systems. This...

  • Technical Support Specialist

    hace 1 día

    Rosario, Argentina StratifyIQ A tiempo completo

    Job Summary: Join our team as a Technical Support Specialist, providing exceptional remote support. You'll review and update support tickets, troubleshoot issues, and ensure prompt resolutions while documenting processes. Ideal candidates have technical support experience, excellent communication skills, and proficiency with CRM/ticketing systems. This role...

  • Remote Travel Specialist

    hace 1 día

    Rosario, Argentina Hjbtravels A tiempo completo

    As a Remote Travel Specialist, you will be an essential part of our team, guiding clients through every stage of their journey—from the moment they plan their trip to their safe return home. Your role is to ensure a seamless, stress-free experience by assisting with travel arrangements, answering questions, managing updates, and resolving any challenges...

  • Remote Travel Specialist

    hace 4 horas

    Rosario, Argentina Hjbtravels A tiempo completo

    As a Remote Travel Specialist, you will be an essential part of our team, guiding clients through every stage of their journey—from the moment they plan their trip to their safe return home. Your role is to ensure a seamless, stress-free experience by assisting with travel arrangements, answering questions, managing updates, and resolving any challenges...

  • Remote Travel Specialist

    hace 4 horas

    Rosario, Argentina HJB Travels A tiempo completo

    As a Remote Travel Specialist, you will be an essential part of our team, guiding clients through every stage of their journey—from the moment they plan their trip to their safe return home. Your role is to ensure a seamless, stress‑free experience by assisting with travel arrangements, answering questions, managing updates, and resolving any challenges...

  • Remote Travel Specialist

    hace 4 horas

    Rosario, Argentina Hjbtravels A tiempo completo

    As a Remote Travel Specialist, you will be an essential part of our team, guiding clients through every stage of their journey—from the moment they plan their trip to their safe return home. Your role is to ensure a seamless, stress-free experience by assisting with travel arrangements, answering questions, managing updates, and resolving any challenges...

  • Senior Business Analyst Top U.s. Web Development..

    hace 2 días

    Rosario, Argentina Prometeo Talent A tiempo completo

    **Halo Media** is seeking a **Senior** **Business Analyst **to help our teams deliver with high quality and on time. You will also deliver amazing digital products by working closely with other engineers and UI/UX designers. We encourage talented individuals of all backgrounds to apply. **Role Responsibilities** Clarifying a business idea. To understand...

  • QA Specialist: Manual

    hace 1 día

    Rosario, Argentina We Clone You A tiempo completo

    Invisible Expert Marketplace OverviewJoin to apply for the QA Engineer Specialist role at Invisible Expert Marketplace. Design, develop, and maintain comprehensive test plans, test cases, and testing frameworks for both manual and automated testing. Execute complex manual testing tasks and contribute to automation initiatives. QA Analyst Language QA Analyst...