Site Activation Specialist in Brazil

3 semanas atrás

São Paulo, Brasil IQVIA Tempo inteiro

Under moderate supervision, the Site Activation Specialist executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level.
Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project timelines.

Essential Functions
• With moderate oversight and supervision, serve a Single Point of Contact (SPOC) to perform feasibility, site activation and some maintenance 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, consistency and accuracy, under guidance of senior staff.
• Prepare site documents, reviewing for completeness and accuracy.
• Inform team members of completion of regulatory contractual. and other documents for individual sites.
• Distribute completed documents to sites and internal project team members.
• Update and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
• Review, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents. Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.

Qualifications
• Bachelor's Degree Life sciences or a related field
• 1 - 2 years of experience in clinical research regulatory and the following particular experience:

CEP/CONEP - initial submission for Main Site and remaining sites, amendments to Main Site and Remaining sites, Notifications; ICF - Review and adaptation of local requirements (Country customization); ANVISA (MoH) - Initial DEEC Submission, Substantial Protocol Amendments, FAEC Update (Anvisa Clinical trial Form), annual study report (DEEC), Annual Safety Report (DDCM)

• Advanced level of English skills

• Great communication skills and ability to work in a team.

#LI-NRJ

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

  • Site Activation Specialist in Brazil

    4 semanas atrás

    Sao Paulo, Brasil IQVIA Tempo inteiro

    Under moderate supervision, the **Site Activation Specialist **executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level. Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites...

  • Site Activation Specialist in Brazil

    3 semanas atrás

    São Paulo, Brasil IQVIA Tempo inteiro

    Under moderate supervision, the Site Activation Specialist executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level. Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites...

  • Site Activation Coordinator in Brazil

    3 semanas atrás

    São Paulo, Brasil IQVIA Tempo inteiro

    Job Overview Under general supervision, perform tasks at a country level associated with contracts for 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 activities. Essential...

  • Sr. Site Activation Specialist for Contracts in

    4 semanas atrás

    Sao Paulo, Brasil IQVIA Tempo inteiro

    **Job Overview** Under general supervision, **perform tasks at a country level associated with contracts for 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 activities. **Essential...

  • Site Activation Specialist

    Há 3 dias

    São Paulo, Brasil IQVIA Tempo inteiro

    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 activities. Essential Functions • Under...

  • Site Activation Specialist

    3 semanas atrás

    Sao Paulo, Brasil IQVIA Tempo inteiro

    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 activities. Essential Functions - Under general...

  • Site Activation Specialist

    4 semanas atrás

    Sao Paulo, Brasil Novasyte Tempo inteiro

    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...

  • Assoc. Site Activation Manager

    1 semana atrás

    São Paulo, Brasil IQVIA Tempo inteiro

    Associate Site Activation Manager – Sponsor Dedicated Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work and resources. You will: Oversee the execution of Site Activation and Maintenance...

  • (Assoc) Global Site Activation Analyst in LATAM

    3 semanas atrás

    São Paulo, Brasil IQVIA Tempo inteiro

    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...

  • Activation Marketing Specialist

    4 semanas atrás

    Sao Paulo, Brasil 3M Tempo inteiro

    **Job Description**: - Activation Marketing Specialist - Transportation Safety Division_ - ._ Collaborate with 3Mers innovators around the world As an Activation Marketing Specialist you will play a key role in the definition, activation and execution of the business plan and marketing plan that allows you to boost the generation of demand for the TSD in...

  • Sales Specialist

    4 semanas atrás

    São Paulo, Brasil Wayzim Technology Co., Ltd. Tempo inteiro

    Position Summary:Wayzim is seeking a Sales Specilist or Sales engineer in Brazil. The primary role of the Sales Specialist is to bring the customer

  • Associate Site Contract Specialist

    4 semanas atrás

    Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local/accepted process. - Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with company contractual considerations, client contractual considerations, established process with...

  • Fsp Site Activation Partner

    4 semanas atrás

    Sao Paulo, Brasil Parexel Tempo inteiro

    The Site Activation Partner is responsible for leading or supporting operational activities from startup to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Client standards. **Clinical Trial Site Activation** - Initiate and coordinate...

  • Customer Success Specialist

    1 semana atrás

    São Paulo, Brasil Cropin Tempo inteiro

    Location: Brazil Job Summary The Senior Specialist will proactively engage with customers to provide strategic and tactical guidance to them in order

  • Site Identification Specialist

    4 semanas atrás

    Sao Paulo, Brasil PSI CRO Tempo inteiro

    **Company Description** PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. **Job Description** Home-based position in...

  • Regulatory Specialist 1

    2 semanas atrás

    São Paulo, Brasil IQVIA Tempo inteiro

    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...

  • Customer Relations Legal Specialist

    Há 4 dias

    São Paulo, Brasil Deutsche Lufthansa AG Tempo inteiro

    Tasks This is what your tasks as Customer Relations Legal Specialist for Brazil look like: Management and quality control of all legal and NEB (ProCon, consumidor.gov, etc.) customer lawsuits and claims received. Monitoring & coordination of cases (internal/external stakeholders) Ensure proper handling of payments and filing of complete...

  • Site Relationship Partner

    4 semanas atrás

    Sao Paulo, Brasil Pfizer Tempo inteiro

    The Site Relationship Partner is the main Pfizer point of contact for investigative sites; accountable for through a study life cycle; accountable for site start-up activities through site activation; accountable for building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies. The...

  • Customer Support Specialist

    4 semanas atrás

    Sao Paulo, Brasil LeanIX Jobs Tempo inteiro

    LeanIX enables organizations to continuously transform. Our platform helps to efficiently organize, plan, and manage IT landscapes, supporting 1000+ customers with SaaS Management, Enterprise Architecture Management, and Value Stream Management. We are looking for a Customer Support Specialist, based in our Sao Paulo, Brazil who will help evaluate and...

  • Sales Engineer(Based In Brazil)

    Há 5 dias

    São Paulo, Brasil RETEC International Tempo inteiro

    Responsibilities:1.Responsible for the Brazil market research and formulate the marketing strategy; 2.Responsible forsales tasks in Brazil and other