Study Start-up Cra

hace 2 semanas


Madrid, España Novartis A tiempo completo

The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs.
Proactive site preparation and early identification of real site needs and issues and close handover to execution CRA for all sites is key (from issue management to risk identification).
Accountabilities
- Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Study Start-Up Manager, SSO Feasibility Manager as well as SSO Site Partnership Manager
- Collaborates with SSO Study Start-Up Manager, SSO Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments
- Accountable for timely start-up activities from country allocation until site greenlight at assigned sites
- Conducts site selection visits, verifies site eligibility for a specific study
- Main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation
- Ensures that milestones (KPIs) and time schedule for study start-up are met as planned
- Facilitates the preparation and collection of site and country level documents
- Collects submission relevant site-specific documents (e.g., FD, CV, GCP certificates, DSL...) for all relevant site personnel within agreed timelines
- Supports SSU Manager in preparation of country-specific documents, e.g., ICF, patient facing materials, etc.
- Supports SSO Study Start-Up Manager and assigned sites in vendor set-up activities
- Prepare and finalize site specific documents for submission
- Negotiates investigator payments as needed
- Supports preparation of financial contracts between Novartis and investigational sites and investigators as needed
- Updates all systems until site Green Light on an ongoing basis
- Supports preparation of audits and inspections as applicable
- Supports reduction of formal site-specific IRB/IEC deficiencies

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

Skills and Experience Required
- A degree in scientific or health discipline, preferably with clinical operations experience
- Minimum 3 years’ experience in clinical operations in a monitoring / site management role
- Advanced understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
- Central/in-house monitoring or field monitoring experience is desirable
- Fluent in both written and spoken English, local language as needed

**Division**

Global Drug Development

**Business Unit**

GCO GDD

**Country**

Spain

**Work Location**

Madrid

**Company/Legal Entity**

Novartis Farmacéutica, S.A.

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No


  • Study Start-up

    hace 1 día


    Madrid, España Pivotal A tiempo completo

    We have an open position for a **STUDY START UP/REGULATORY ASSOCIATE** with at least 1-3 years of experience to join our Regulatory unit within the clinical operations department. **RESPONSIBILITIES**: Providing the list of documents necessary for initial submissions to CA and EC to request authorization Ensuring the documentation prepared for submission...

  • Senior Study Start-Up Lead

    Encontrado en: Talent ES C2 - hace 1 semana


    Madrid, España Caidya A tiempo completo

    Job Overview: The Senior Study Start-Up Lead (Sr. SSUL) will be involved in managing global and/or regional submission of global applications for clinical trials for studies executed by the Company on behalf of clients. The Sr.SSUL should be able to independently compile, review and approve CORE essential study documents and have solid understanding...

  • Senior Cra

    hace 1 día


    Madrid, España Meet Recruitment A tiempo completo

    40000 EUR - 55000 EUR - Madrid, Spain - Permanent **Overview**: This is a fantastic opportunity to join a Mid-sized but rapidly growing Madrid Based CRO, with sites and operations across the Europe, this organisation is having a period of great success and looking to really grow into a powerhouse CRO within the EU and US. Looking for a Senior CRA who will...


  • Madrid, España Novasyte A tiempo completo

    Job Overview 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, budget and resources. Essential Functions - Oversee the execution of Site Activation (including pre-award/bid defense activities)...

  • Study Nurse

    hace 1 semana


    Madrid, España IQVIA A tiempo completo

    Are you looking for an opportunity or a new challenge in Clinical Research? Do you want to work for an industry leading company? IQVIA is currently recruiting for a **Research/Study Nurse **to work at our site in Madrid to support conducting a clinical trial. This part time role (24 h per week) with an immediate start is planed for **1,5 years.** **Day to...

  • Study Nurse

    hace 1 semana


    Madrid, España Novasyte A tiempo completo

    Are you looking for an opportunity or a new challenge in Clinical Research? Do you want to work for an industry leading company? - IQVIA is currently recruiting for a Research/Study Nurse to work at our site in Madrid to support conducting a clinical trial. This part time role (24 h per week) with an immediate start is planed for 1,5 years.Day to day...

  • Lead Cra

    hace 5 horas


    Madrid, España Oracle A tiempo completo

    Lead CRA-2300052B **Applicants are required to read, write, and speak the following languages***: English **Preferred Qualifications** Cerner Enviza is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Cerner Enviza, you...

  • Lead Cra

    hace 5 horas


    Madrid, España Oracle A tiempo completo

    Lead CRA-2300021R **Applicants are required to read, write, and speak the following languages***: English **Preferred Qualifications** Cerner Enviza is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Cerner Enviza, you...

  • Cfsp Cra 1

    hace 6 días


    Madrid, España 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...


  • Madrid, España Boston Scientific Corporation A tiempo completo

    **Work mode**:Remote in Country**Onsite Location(s)**:Madrid, ES**#Boston Scientific** - For more than 40 years, Boston Scientific has been the world's leading medical device company dedicated to improving the lives of patients. Every day, we face the key challenges of the healthcare industry with innovative products, a culture of collaboration and a deep...

  • Cfsp Sr Cra 1

    hace 1 semana


    Madrid, España Novasyte A tiempo completo

    and therapeutic areas. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. - Administer protocol and related study training to...


  • Madrid, España ABBVIE A tiempo completo

    To enable AbbVie’ s emergence as a world class R&D organization, the position anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action ensuring successful protocol level execution of SMM deliverables involving start-up, execution, and close-out of studies. - Monitors...


  • Madrid, España Syneos - Clinical and Corporate - Prod A tiempo completo

    **Description** **Sr CRA I** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of...


  • Madrid, España AstraZeneca A tiempo completo

    At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. This role is responsible for ensuring the local implementation of the operational site relationship management...


  • Madrid, España ABBVIE A tiempo completo

    To enable AbbVie’ s emergence as a world class R&D organization, the position anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action ensuring successful protocol level execution of SMM deliverables involving start-up, execution, and close-out of studies. - Monitors...


  • Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Research Associate II** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the...

  • Sr Cra

    hace 1 semana


    Madrid, España Novasyte A tiempo completo

    Internal Job Description - Join us in our exciting journey!!- We currently require a motivated, creative and enthusiastic clinical trials professional to join our rapidly growing Site Management division.- As an experienced Clinical Research Associate, you could be looking to broaden your therapeutic, geographic or study exposure. Or perhaps you are looking...

  • Cra Ii

    hace 1 semana


    Madrid, España Ergomed A tiempo completo

    Job Description Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities,...


  • Madrid, España Morgan Philips Executive Search A tiempo completo

    Importante laboratorio multinacional farmacéutica, está buscando incorporar en su Departamento de Operaciones Clínicas un/a Oncology Global Project Manager. **Key Responsibilities**: - The Global Project Manager is accountable for delivering the committed part of all clinical interventional studies under their supervision according to agreed resources,...

  • Cra Ii

    hace 1 semana


    Madrid, España Ergomed A tiempo completo

    Job Description Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the studyIdentifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment...