Regulatory & Start Up Specialist 2, Cfsp

hace 7 días

Desde casa, México IQVIA A tiempo completo

**Regulatory & Start Up Specialist, c**FSP.**

Location: Mexico - Full home based

**Job Overview**

This position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a **point of contact for investigative sites and the study team members.** This includes supporting **site qualification**, site level regulatory green light and site **maintenance/close-outs**.

**Essential Functions**
- Participate in development of in-house model process documents.
- For assigned sites and countries, serve as a primary site contact for end-to-end study activity.
- Participate in all assigned Study Site Management study team meetings, providing cross-functional teams with detailed updates related to study and site activity.
- Utilize systems and tools to track assigned activities and produce reports and metrics as needed.
- Oversee essential document collection, tracking & review.
- Support the collection of country and site level intelligence
- Support Ethics Committee and Regulatory Authority submissions
- Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate or maintain sites for a study as appropriate.

**Qualifications**
- Bachelor’s Degree in Business Administration, Finance, science or related field or work experience equivalent.
- Minimum of three years of relevant experience in the biopharmaceutical/CRO industry, **including experience in EC submission in US.**
- Fluent English: written and oral communication skills
- Ability to negotiate complex contract and payment terms.
- Goal oriented, self-starter with proven ability to work independently.
- Able to proactively identify issues and provide potential solutions for resolution.
- Detail oriented.
- Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
- Good interpersonal skills

  • Regulatory & Start Up Specialist, Cfsp

    hace 2 semanas

    Desde casa, México IQVIA A tiempo completo

    We are looking for a **Regulatory & Start Up Specialist** to join our cFSP team in a Home Based role!**Location**: Argentina & México**What You´ll Do**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...

  • Regulatory & Start Up Specialist 2, Cfsp

    hace 5 días

    Desde casa, México IQVIA A tiempo completo

    **Regulatory & Start Up Specialist, c**FSP.**Location: Mexico - Full home based**Job Overview**This position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a **point of contact for investigative sites and the study team members.** This includes supporting **site qualification**, site level...

  • Local Start Up Specialist

    hace 2 semanas

    Desde casa, México Allucent A tiempo completo

    These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in...

  • Fsp - Regulatory and Start Up Specialist Mex

    hace 3 días

    Desde casa, México IQVIA A tiempo completo

    We are looking for a **Regulatory & Start Up Specialist** to join our FSP team in a Home Based role!**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...

  • Regulatory & Start Up Specialist I - Central Hub

    hace 3 semanas

    Desde casa, México IQVIA A tiempo completo

    **Job Overview**Perform country-level tasks related to Site Activation (SA) activities at a global scope, ensuring compliance with local and international regulations, standard operating procedures (SOPs), project requirements, and budgetary guidelines. This role may also involve maintenance activities.**Essential Functions**:- Serve as Single Point of...

  • Sr Study Start-up Specialist

    hace 2 semanas

    Desde casa, México IQVIA A tiempo completo

    **BASIC FUNCTIONS**: Responsible for the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED) and Investigator Site Files (ISF) during start-up. Work with both internal and external teams to assure good communication, regarding documentation processing. Assure documents maintained are following International...

  • Study Start-up Specialist/manager

    hace 3 días

    Desde casa, México IQVIA 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...

  • Cfsp Cra 2

    hace 5 días

    Desde casa, México IQVIA A tiempo completo

    Job OverviewPerform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.Essential Functions- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with...

  • Regulatory and Start Up Clinical Research Spec

    hace 3 días

    Desde casa, México IQVIA A tiempo completo

    Job OverviewPerform 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...

  • Regulatory Specialist 2, Fsp

    hace 4 semanas

    Desde casa, México IQVIA 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,...