Study Start-up Specialist I/ii, Peru

hace 2 semanas

Lima, Perú Novasyte A tiempo completo

Help create a healthier world: START RIGHT HERE AT IQVIA.

Proficiency in English, both verbally and written are necessary.

Please submit resume in English.

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.

KNOWLEDGE, SKILLS & ABILITIES:
- Knowledge of clinical research process related to study start-up and medical terminology- A basic understanding of Regulatory and Central/Local ethic submission processes for assigned countries- Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members- Excellent organizational and interpersonal skills- Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities- Ability to manage multiple competing priorities within various clinical trials- Working knowledge of current ICH GCP guidelines and applicable regulations- Ability to reason independently, assess and recommend specific solutions in clinical settings, and mentor administrative staff- Excellent verbal and written communication skills required in local language for assigned countries- Ability to work independently, prioritize and work with a matrix team environment is essential- Working knowledge of Word and Excel is required- Ability to travel periodically if needed

PHYSICAL REQUIREMENTS:
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech- Extensive use of keyboard requiring repetitive motion of fingers- Regular sitting for extended periods of time

MINIMUM RECRUITMENT STANDARDS:
- Bachelor’s degree (or equivalent), preferably in science or related field and 6 months - 4 years relevant experience. Specialist I needs at least 6 months experience and Specialist II needs at least 1.5 years experience related to study start-up and maintenance activities.- Equivalent combination of education, training and experience

LI-RW1

LI-Remote

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

  • Vertical Start Up

    hace 4 días

    Lima, Perú Mondelēz International A tiempo completo

    **Job Description**: **Are You Ready to Make It Happen at Mondelēz International?** **Join our Mission to Lead the Future of Snacking. Make It With Pride.** You plan, develop and execute capital projects by supporting technical developments, feasibility perspectives of engineering-related activities in supply chain and capital expense project execution to...

  • Specialist Field Service Technician Level Ii

    hace 10 horas

    Lima, Perú Sandvik A tiempo completo

    Las personas apasionadas crean cosas excepcionales. Somos Sandvik, grupo mundial fundada en 1862, pionero de la ingeniería de alta tecnología para la excavación y perforación de rocas, que ofrece soluciones que mejoran la productividad, la rentabilidad y la sostenibilidad para las industrias de fabricación, minería e infraestructuras. Es por ello,...

  • Service Delivery PM Peru

    Encontrado en: Talent PE C2 - hace 1 semana

    Lima, Perú Lenovo A tiempo completo

    Description and Requirements Service Delivery Specialist Responsible for the End-to-End Services in the country under scope Peru, having as key pillars service efficiency, cost control/reduction and Customer Satisfaction, interacting with other cross areas inside Services team such as Contact center, Logistics, Parts, Global Accounts and of...

  • Cfsp Cra 2

    hace 4 días

    Lima, Perú IQVIA A tiempo completo

    Job Overview Perform 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...

  • Peru Operations Specialist

    Encontrado en: Talent PE C2 - hace 1 semana

    Lima, Perú G Adventures A tiempo completo

    About UsG Adventures is the world’s largest small-group adventure travel company and we’ve been making epic travel memories happen on all seven continents for over 30 years.Our mission is simple: to change lives through travel. And not just our travelers’ either. Since day one, our tours have been built to establish meaningful relationships with local...

  • Chofer - Urgente

    hace 3 semanas

    Lima, Perú POP UP EIRL A tiempo completo

    **POP UP E.I.R.L**, empresa dedicada a la producción e instalación de material publicitario. Se encuentra en la búsqueda de nuevos talentos, para desempeñarse en la posición de **CHOFER** **Requisitos**: *Experiência mínima de 2 años en reparto *Categoría de brevete A2B *Disponibilidad para trabajar en horario completo. **FUNCIONES**: *Manejo de...

  • Short Term Rental Listing Specialist

    hace 3 días

    Lima, Perú Independent Recruiter A tiempo completo

    We're helping one of our clients, Midtown Stays, hire a Short Term Rental Listing Specialist. “Join a fun and quickly expanding team of professionals helping property owners better manage their Airbnbs.” Compensation: USD 4.5 - 7.5/hour. - Health insurance Location: Remote (for Brazil, Colombia, Ecuador, Peru, Bolivia, Uruguay, Paraguay, Argentina,...

  • Short Term Rental Listing Specialist

    hace 2 días

    Lima, Perú Independent Recruiter A tiempo completo

    We're helping one of our clients, Midtown Stays, hire a Short Term Rental Listing Specialist. “Join a fun and quickly expanding team of professionals helping property owners better manage their Airbnbs.” Compensation: USD 4.5 - 7.5/hour. - Health insurance Location: Remote (for Brazil, Colombia, Ecuador, Peru, Bolivia, Uruguay, Paraguay, Argentina,...

  • Senior Technical Specialist

    hace 6 días

    Lima, Perú ABB A tiempo completo

    **Senior Technical Specialist**: **Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and generations. Together, we are...

  • Resettlement Specialist

    Encontrado en: Talent PE C2 - hace 1 semana

    Lima, Perú HIAS A tiempo completo

    POSITION SUMMARY: HIAS seeks a Resettlement Specialist who will contribute toward promoting resettlement as a durable solution for at-risk refugee populations in Peru. The Resettlement Specialist will support the country-level implementation of the Equitable Resettlement Access Consortium (ERAC) program. ERAC is a program designed to identify local...

  • IT Helpdesk Support Specialist

    hace 4 días

    Lima, Perú Peru Process Solutions SRL A tiempo completo

    **IT HELPDESK SUPPORT SPECIALIST** PPS is a company that provides numerous off-shore services to our stateside affiliates (law firms). It specializes in offering workforce solutions backed by strong technological systems and a team focused on helping the final client. We focus on providing pre-litigation and discovery assistance in the form of case...

  • Bilingual Intake Specialist

    hace 7 días

    Lima, Perú eCustom Solutions A tiempo completo

    **Bilingual Intake Specialist (English & Spanish)** Are you fluent in both Spanish and English, with a passion for delivering exceptional customer service? Do you have a background in sales and a solid understanding of the legal industry? If so, we want to hear from you! eCustom Solutions is seeking a talented Bilingual Intake Specialist to join our dynamic...

  • Short Term Rental Listing Specialist

    hace 2 semanas

    Lima, Perú Worldwide Recruiter A tiempo completo

    We are looking for a Short Term Rental Listing Specialist on behalf of our client Midtown Stays. “(100% virtual) Join a fun and quickly expanding team of professionals helping property owners better manage their Airbnbs.” Compensation: USD 4.5 - 7.5/hour. + Health insurance Location: Remote (for Brazil, Colombia, Ecuador, Peru, Bolivia, Uruguay,...

  • Short Term Rental Listing Specialist

    hace 2 semanas

    Lima, Perú Worldwide Recruiter A tiempo completo

    We are looking for a Short Term Rental Listing Specialist on behalf of our client Midtown Stays. “(100% virtual) Join a fun and quickly expanding team of professionals helping property owners better manage their Airbnbs.” Compensation: USD 4.5 - 7.5/hour. + Health insurance Location: Remote (for Brazil, Colombia, Ecuador, Peru, Bolivia, Uruguay,...

  • Short Term Rental Listing Specialist

    hace 3 días

    Lima, Perú Worldwide Recruiter A tiempo completo

    We are looking for a Short Term Rental Listing Specialist on behalf of our client Midtown Stays. “Join a fun and quickly expanding team of professionals helping property owners better manage their Airbnbs.” Compensation: USD 4.5 - 7.5/hour. + Health insurance Location: Remote (for Brazil, Colombia, Ecuador, Peru, Bolivia, Uruguay, Paraguay, Argentina,...

  • Short Term Rental Listing Specialist

    hace 3 días

    Lima, Perú Worldwide Recruiter A tiempo completo

    We are looking for a Short Term Rental Listing Specialist on behalf of our client Midtown Stays. “Join a fun and quickly expanding team of professionals helping property owners better manage their Airbnbs.” Compensation: USD 4.5 - 7.5/hour. + Health insurance Location: Remote (for Brazil, Colombia, Ecuador, Peru, Bolivia, Uruguay, Paraguay, Argentina,...

  • Specialist-guest Experience

    hace 4 días

    Lima, Perú Marriott International, Inc A tiempo completo

    **Numéro de l'Emploi** 22198438 **Catégorie d'Emploi** Rooms & Guest Services Operations **Lieu** Fairfield Lima Miraflores, Calle Martin Dulanto 128, Lima, Peru, Peru AFFICHER SUR LA CARTE **Horaire** Full-Time **Situé à distance ?** N **Mutation?** N **Type de Poste** Non-Management Notre travail ne se limite pas à offrir à nos clients un...

  • Site Activation Manager

    Encontrado en: Talent PE C2 - hace 1 semana

    Lima, Perú IQVIA A tiempo completo

    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 teams ensuring that our...

  • Financial Planning

    hace 7 días

    Lima, Perú BCP A tiempo completo

    **FINANCIAL PLANNING & ANALYSIS SENIOR SPECIALIST** Queremos que tu talento se sume al del BCP, para seguir siendo el banco que todo el tiempo está innovando, es pionero y digital. Juntos tendremos la posibilidad de generar un impacto positivo en nuestro país, teniendo como objetivo que los peruanos logren transformar sus planes en realidad....

  • Specialist-property Admin

    hace 6 días

    Lima, Perú Marriott International, Inc A tiempo completo

    **Numéro de l'Emploi** 23005020 **Catégorie d'Emploi** Administrative **Lieu** Sheraton Lima Historic Center, Paseo de la Republica 170, Lima, Peru, Peru AFFICHER SUR LA CARTE **Horaire** Full-Time **Situé à distance ?** N **Mutation?** N **Type de Poste** Non-Management Les spécialistes de l’administration de la propriété jouent un rôle...