Sr Site Mgr 1, Real World Evidence

hace 4 semanas

Bogota, Colombia Novasyte A tiempo completo

Job Overview

Responsible for remote site monitoring activities 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
- Serves as an in-house CRA responsible for site management on assigned sites.
- Performs study evaluation, initiation, remote monitoring, and close out visits remotely as appropriate. May monitor and/or co-monitor at sites when needed.
- Collaborates with field CRAs on assigned sites.
- Mentors and provides guidance and training to other in-house CRAs as necessary.
- Serves as a primary contact between IQVIA and the investigative site on assigned sites and ensures proper documentation of site management communications.
- Serves as back-up to assigned field CRAs and/or in-house CRAs
- In collaboration with the assigned field CRA, performs routine site management activities, including site training, assistance with site questions, patient recruitment and retention management, study supplies management, and other activities needed to ensure that assigned sites are conducting the study(ies) as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
- Collaborates with assigned field CRAs to resolve and document outstanding site issues/action items
- reviews the quality and integrity of patient data at assigned sites through the remote review of electronic case report form (CRF) data. Ensures timely transmission of clinical data from assigned study sites and works with sites to resolve data queries
- Assists with final data review and query resolution through database lock. Inclusive of patient profile and data listings review
- Assists with the development of the Integrated/Clinical Data Review Plan for assigned studies
- Assists with the development of patient profile and data listings for review during data cleaning activities
- Assists with the development of risk assessment thresholds and recommended actions for Key Performance Indicators (KPIs) for a study or program
- Makes recommendations about adjustments to KPIs and data analytics reviewed to ensure output continues to be appropriate.
- Designs data analytics to assess risk and works with appropriate functional department/vendor to program the designed reports
- assists with and attends (as needed) Investigator Meetings on assigned studies
- Authorized to request site audits for reasons of validity
- performs other duties as requested by Management.
- May assist in the creation of Risk-Based Quality Management process and documentation plans for data surveillance analyses. Ensure that risk-based quality trial management processes are performed to identify, assess, control, communicate and review study risk.
- May help ensure timely and appropriate site payments and updates the clinical team as required to ensure proper timing and amount of payments.

**Qualifications**:

- Degree in scientific discipline or health care (preferred).
- Minimum of 3 years clinical research experience (regulatory and monitoring responsibilities) required.
- Good written and verbal communication skills including good command of English language.
- Good organizational and problem-solving skills.
- Ability to manage multiple priorities within various clinical trials.
- Ability to reason independently to assess and recommend specific solutions in clinical settings.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Ability to understand electronic data capture including basic data processing functions.
- Familiarity with current International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and applicable regulations to the conduct of clinical research.
- Ability to mentor other employees.

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

  • Real World Evidence Consultant

    hace 3 semanas

    Bogota, Colombia Novasyte A tiempo completo

    Join our Team as a Real World Evidence Consultant to provide high quality, on-time input to client projects in the life sciences field. Assignments range in complexity from basic analysis and problem solving to assisting in the development of more complex solutions. The essential functions you would be in charge of are: - Design and implement systematic...

  • Real World Evidence Consultant

    hace 3 semanas

    Bogota, Colombia IQVIA A tiempo completo

    Join our Team as a** Real World Evidence Consultant **to provide high quality, on-time input to client projects in the life sciences field. Assignments range in complexity from basic analysis and problem solving to assisting in the development of more complex solutions. **The essential functions you would be in charge of are**: - Design and implement...

  • Account Mgr., Retail Sales

    hace 1 semana

    Bogota, Colombia Epson America, Inc A tiempo completo

    **Responsible for**: - Supervises the promotion of the Epson products through the retail channels, assuring the inventory maintenance at national level, supervise the trainings teaching to the channels with a high service grade and communication with the clients and with the company, in order to promote the product sale on detecting any opportunity of...

  • Evidence Synthesis Associate Consultant

    hace 2 semanas

    Bogota, Colombia Novasyte A tiempo completo

    Join our team as an Evidence Synthesis Associate Consultant supporting rigorous analyses and critical appraisals of published medical evidence across a wide range of diagnostic, prognostic, therapeutic, and other clinical interventions, as well as drafting reports. This professional will also provide technical expertise on evidence synthesis methods,...

  • Sr Site Activation Coordinator

    hace 4 días

    Bogota, Colombia IQVIA A tiempo completo

    **Job Overview** The Sr Site Activation Coordinator will give support to **Argentina**. 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....

  • Sr/site Activation Coordinator

    hace 2 meses

    Bogota, Colombia IQVIA A tiempo completo

    **Join us as a Sr Site Activation Coordinator!** **Job Overview** Under general supervision, perform tasks at a country/region 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...

  • Evidence Synthesis Associate Consultant

    hace 3 semanas

    Bogota, Colombia IQVIA A tiempo completo

    Join our team as an **Evidence Synthesis Associate Consultant** supporting rigorous analyses and critical appraisals of published medical evidence across a wide range of diagnostic, prognostic, therapeutic, and other clinical interventions, as well as drafting reports. This professional will also provide technical expertise on evidence synthesis methods,...

  • Sr Site Activation Coordinator

    hace 3 semanas

    Bogota, Colombia Novasyte A tiempo completo

    Job Overview Under moderate supervision, 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;...

  • Real Estate Coordinator

    hace 4 semanas

    Bogota, Colombia Future In-Site Realty Associates, Inc. A tiempo completo

    Job Title: Real Estate Coordinator We are a Commercial Real Estate Brokerage in the USA focusing on representing clients on Buying/Selling/Leasing their Child Care property. As one of the most experienced brokers in the child care industry, we are shifting gears from representing one client, to representing many clients. Job Responsibilities: - Use Google...

  • Real Time Analyst Manager

    hace 3 semanas

    Bogota, Colombia IntouchCX A tiempo completo

    About IntouchCX IntouchCX is a global leader in customer experience management, digital engagement, and AI and automation solutions. We immerse ourselves in your world with curiosity, creativity, and innovation to deliver exceptional results. For over 20 years, we have scaled with soul to become a disruptive industry leader by building trusted long-term...

  • Real Estate Coordinator

    hace 4 semanas

    Bogota, Colombia Future In-Site Realty Associates, Inc. A tiempo completo

    Job Title: Real Estate Coordinator We are a Commercial Real Estate Brokerage in the USA focusing on representing clients on Buying/Selling/Leasing their Child Care property. As one of the most experienced brokers in the child care industry, we are shifting gears from representing one client, to representing many clients. Job Responsibilities: - Use Google...

  • Mgr Regional Sales Ii

    hace 3 semanas

    Bogota, Colombia The Manitowoc Company A tiempo completo

    Have you been looking for the chance to use your expertise to make a real difference in an organization? Manitowoc Cranes* is seeking a **Mgr. Regional Sales II **to join our team! **This position is responsible for mobile crane business (new/used) in Colombia, Peru and Argentina region. Accountable for market share grow and revenue goals set in yearly...

  • Sr Mgr Tech Support

    hace 3 semanas

    Bogota, Colombia Optum Global Advantage A tiempo completo

    **Número de la requisición**: 2170042 **Categoría de la vacante**: Tecnología **Ubicación**: Bogotá, Distrito Capital de Bogotá Compartir This Senior Manager Tech Support oversees the whole IT support structure and leadership in all transactional and fundamental need for flawless business operations execution for Optum Colombia. A Sr. Manager with...

  • Client Onboarding Sr Grp Mgr

    hace 4 semanas

    Bogota, Colombia Citi A tiempo completo

    The Colombia Hub TTS Onboarding head manages a team of managers responsible for the end-to-end client experience within onboarding, which includes account opening, account maintenance and product implementations for the Institutional Clients Group. This Client Onboarding Sr Grp Mgr must have a good understanding of the industry, direct competitors' products...

  • Canada World School

    hace 4 semanas

    Bogota, Colombia Canada World School A tiempo completo

    **About us** Our goal is to is to empower students globally to reach their full potential and achieve their aspirations through education. We offer the Ontario Secondary School Diploma (OSSD) to schools and language learning institutes around the world, allowing students to earn their high school diploma from the comfort of their own homes and communities....

  • Canada World School

    hace 4 semanas

    Bogota, Colombia Canada World School A tiempo completo

    **About us** Our goal is to is to empower students globally to reach their full potential and achieve their aspirations through education. We offer the Ontario Secondary School Diploma (OSSD) to schools and language learning institutes around the world, allowing students to earn their high school diploma from the comfort of their own homes and communities....

  • Real Estate Podcast Host

    hace 2 meses

    Bogota, Colombia Ardor SEO A tiempo completo

    **The Icons of Real Estate is hiring a Podcast Host with experience in sales and real estate!** Do you have a knack for sales? Do you enjoy talking to people? Do you have your Real Estate License or have an interest in Real Estate? This is the perfect position for you! **Key Skills Required**: - Exceptional Communication Skills (English speaking) -...

  • Sr. Data Engineer

    hace 3 semanas

    Bogota, Colombia Devlane A tiempo completo

    Hello there! We are Devlane, a software development company with presence across all of LATAM, that’s currently offering staff augmentation services to clients around the world, with a special focus in North America. With us, you’ll have a real opportunity to shine and leave a footprint on the project you are assigned to since most of our clients are...

  • Bd & Sales Mgr I

    hace 4 días

    Bogota, Colombia Cencora A tiempo completo

    - What you will be doing - Versión 3.0/BOG/JUN2020 Job Description (_Descripción de puesto)_ POSITION TITLE (_TÍTULO DE LA POSICIÓN_): BD & Sales Mgr I Representative - (cargo: Gerente de I de desarrrolo de Negocios y ventas)_ COUNTRY _(_PAÍS_)_: Colombia (_Colombia _) DEPARTMENT _(_ÁREA_)_: Sales _(Ventas)_ (RESUMEN DE LA POSICIÓN): Under broad...

  • Site Activation Coordinator in Colombia

    hace 2 semanas

    Bogota, Colombia Novasyte A tiempo completo

    The Site Activation team performs tasks at a region 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 feasibility or maintenance activities. What we require: - Perform site...