Sr. Site Activation Specialist in Argentina

hace 5 meses

Buenos Aires, Argentina Novasyte A tiempo completo

The Sr. Site Activation Specialist will 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. Developing professional individual contributor who works under moderate oversight and supervision. Responsible for making recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area. Problems faced are general and may require understanding of broader set of issues but are not complex.

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 feasibility, site ID, 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 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 fesibility, site ID, regulatory and contractual documents for individual sites.
- Review, track and follow up the progress, the approval and execution of documents, questionnaires, CDA/SIF, 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 Life science or related field Req And
- 3 years’ of relevant experience working in the regulatory department in Argentina:

- Local and regional committees - Initial submission, Amendments, Response to Pending Issues.
- ANMAT and CCIS - Initial submission (EFCA1), list and calculation of medicines to be imported, Inclusion of centers (EFCA2), Amendments (EFCA3), Response to Pending Issues, IB Notification (EFCA4)
- ICF - Country and Site Specific Customization
- Essential Documents Collection
- TMF
- Update Trackers and Check lists.
- Advanced level of English
- Ability to work independently

LI-NRJ #LI-Hybrid

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

  • Sr. Site Activation Specialist in Argentina

    hace 5 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    The **Sr. Site Activation Specialist** will 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. Developing professional...

  • Sr. Site Activation Specialist

    hace 5 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Sr Site Activation Specialist Home Based - Argentina 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....

  • Site Activation Coordinator Based in Argentina

    hace 5 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    **Essential Functions** - Under general supervision, perform site activation activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness,...

  • Site Activation Specialist, External Commerce

    hace 6 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    **Site Activation Specialist for External Commerce (ComEx) - Homebased** **Essential Functions** - Responsible for importations and exportations - 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...

  • Site Activation Specialist, External Commerce

    hace 6 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Site Activation Specialist for External Commerce (ComEx) - Homebased Essential Functions - Responsible for importations and exportations - 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...

  • Site Activation Specialist

    hace 5 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    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...

  • Site Activation Coordinator

    hace 5 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    **Site Activation Coordinator** **Job Overview** Under general supervision, perform tasks at a country level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance...

  • Site Activation Coordinator

    hace 5 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

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

  • Global Site Activation Analyst in Latam

    hace 5 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Manages and executes the site identification process and performs regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements either at the global, regional, or country level. Prepares and manages site regulatory documentation; reviews and negotiates site regulatory documents and contracts with sites and...

  • Intern, Country Site Activation

    hace 5 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    **Pasantía Country Site Activation - Argentina** Part time, Office Based **Essential Functions**: - Under general supervision, perform site activation activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Local Teams and other departments as necessary. - Review...

  • Intern, Country Site Activation

    hace 5 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Pasantía Country Site Activation - Argentina Part time, Office Based Essential Functions: - Under general supervision, perform site activation activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Local Teams and other departments as necessary. - Review documents...

  • Assoc/site Activation Manager

    hace 7 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Internal Job Description - Calling all experienced Site Activation Managers- The Site Activation Manager (SAM) position within GSA team in IQVIA is our project manager for the start-up phase in charge of design and implementation of our strategy towards sites activation from award until open to enrolment. The SAM leads and oversees our country operations...

  • Mgr, Global Site Activation

    hace 5 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Job Overview Manages a regional work unit responsible for site activation. Sets goals and objectives for team members for achievement of short-term operational or tactical results. Essential Functions - Manages staff's delivery of site activation activities in accordance with organization’s policies and applicable regulations. Responsibilities include...

  • Fsp - Sr. Regulatory & Start Up Specialist

    hace 2 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    **Job Overview** The **Regulatory & Start Up Specialist** will 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...

  • Regulatory Specialist

    hace 4 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    {"h1": "Regulatory & Start Up Specialist at IQVIA", "p": "We are seeking a highly skilled Regulatory & Start Up Specialist to join our cFSP team in a Home Based role. As a key member of our team, you will be responsible for performing tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or...

  • Regulatory Specialist

    hace 4 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    Job OverviewThe Regulatory & Start Up Specialist will 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.Key...

  • Fsp - Regulatory and Start Up Specialist 2 - Arg

    hace 5 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    **Job Overview** The **Regulatory & Start Up Specialist 2** will 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...

  • Intern

    hace 5 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    **Pasantía International Commerce (ComEx), Country Site Activation - Argentina** Part time, Office Based (Retiro, CABA) Duración: 12 meses. **Essential Functions**: - Under supervision, support the Site Activation Specialist with importations and exportations. - Support External Commerce Team in the distribution, recollection and tracking of imported...

  • Reg & Start Up Specialist, Us Support, Cfsp

    hace 6 días

    Buenos Aires, Argentina IQVIA A tiempo completo

    **Regulatory & Start Up Specialist, cFSP - US Support** **Argentina - Full Home Based role** **Purpose**: The RSU Specialist 1 proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country: US. **Responsibilities** **Primary responsibilities include but are not...

  • Site Manager

    hace 6 meses

    Buenos Aires, Argentina Johnson & Johnson A tiempo completo

    At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130...