Study Start-up
hace 3 semanas
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 to ECs and CA is in compliance with Spanish regulations
Collection of essential documents necessary for ECs approval from each selected site
Ensuring the final budget agreed with PI and other Departments (if applicable) is included in the draft CTA to be submitted to ECs
Preparing ECs and CA submission packages in line with local requirements
Performing submissions through the OsSC and according to Spanish regulations
Submission of answers to ECs and CA queries, when applicable
Contract and budget negotiation with sites
At least 1-3 years of experience in Regulatory/start-up in clinical trials.
Sound knowledge of GCPs/ICH and international/local regulations
Updated knowledge of national/international regulations relative to clinical Trial Start Up Procedures.
Previous experience in/with:
- Preparation of the request for clinical trials authorization- Competent Authority (CA) and EC/REC/HRA and R&D submissions- Contract and budget negotiation with sites as needed- Fluent in English- Team Management- Good knowledge of Office (Word, Excel and Powerpoint)- Above all, we appreciate motivation, excellent team player, and independent and well-structured way of working
-
Study Start-up Clinical Research Associate
hace 1 mes
Madrid, España Novartis A tiempo completo395138BR **Study Start-Up Clinical Research Associate (Remote)**: Spain **About the role** **Location**:This is a remote, field based role with an average number of 2/3 site visits per week across Spain. As our **Study Start-Up CRA** your role has a high impact for Novartis. This exciting role covers everything from early identification of real site needs...
-
Senior Study Start-up Lead
hace 1 mes
Madrid, España Caidya A tiempo completo**Job Title: Senior Study Start-Up Lead (SSUL)** **Job Location**: Madrid, Spain**Job Overview**: Job Duties and Responsibilities: - Act as a SSU lead for the assigned countries and regions, participating directly at kick-off meetings, sponsor calls, providing the client with procedural and legal guidance, and study updates and advice as how to respond to...
-
Associate Study Start-up Manager
hace 1 mes
Madrid, España Novasyte A tiempo completoAssociate Study Start-Up Manager IQVIA Biotech 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...
-
Project Manager Start Up
hace 1 mes
Madrid, España Labcorp A tiempo completo**Project Manager Start Up, EMEA, Remote** Helping our clients make their clinical trials a success by orchestrating the efforts of top-talented Clinical Research Teams. As **Project Manager Start Up** your principal responsibility is to oversee and manage the start-up through maintenance phase of domestic and/or international clinical trials. This...
-
Senior Study Start-Up Lead
hace 4 semanas
Madrid, España Caidya A tiempo completoJob 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...
-
Local Study Associate Director
hace 1 mes
Madrid, España AstraZeneca A tiempo completoAt 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. To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according...
-
Regulatory and Start Up Manager
hace 4 días
Madrid, Madrid, España IQVIA A tiempo completoJob OverviewDirect 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. Fluent in Spanish and English.Essential Functions Oversee the execution of Site Activation (including...
-
Regulatory and Start Up Manager
hace 5 días
Madrid, España IQVIA A tiempo completoJob 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. Fluent in Spanish and English. Essential Functions Oversee the execution of Site Activation...
-
Associate Project Manager Start Up
hace 24 minutos
Madrid, España Fortrea A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Clinical Research Coordinator
hace 6 días
Madrid, España IQVIA A tiempo completoAre you looking for an opportunity in Clinical Research? Do you want to work for an industry leading company. If so, come and join us - IQVIA are looking for a Clinical Research Coordinator/ Study Nurse. This part-time (24 hours) role, is planned for 11 months and is to support the site in Sanlucar der Barrameda in conducting a clinical trial in the field...
-
Sr Site Contracts Lead
hace 1 mes
Madrid, España Syneos Health Clinical A tiempo completo**Description** **Senior Site Contracts Lead - Europe based** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical...
-
Oncology Cra
hace 1 mes
Madrid, España AstraZeneca A tiempo completoAt 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. The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites...
-
Clinical Research Associate II
hace 2 días
Madrid, España Allucent A tiempo completoAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Clinical Research Associate II (CRAII) to join our A-team (hybrid*/remote). As a CRAII at Allucent, you will independently...
-
Clinical Research Associate II
hace 2 días
Madrid, España Allucent A tiempo completoAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Clinical Research Associate II (CRAII) to join our A-team (hybrid*/remote). As a CRAII at Allucent, you will independently...
-
Clinical Research Coordinator
hace 4 días
Madrid, España IQVIA A tiempo completoAre you looking for an opportunity in Clinical Research? Do you want to work for an industry leading company. If so, come and join us - IQVIA are looking for a Clinical Research Coordinator. This part-time (24 hours) role, is planned for 11 months and is to support the site in Majadahonda in conducting a clinical trial in the field of Cardiology . ...
-
Clinical Research Coordinator
hace 38 minutos
Madrid, España IQVIA A tiempo completoAre you looking for an opportunity in Clinical Research? Do you want to work for an industry leading company. If so, come and join us - IQVIA are looking for a Clinical Research Coordinator. This part-time (20 hours) role, is planned for 11 months and is to support the site in El Palmar, Murcia in conducting a clinical trial in the field of Cardiology ....
-
Clinical Research Assistant
hace 35 minutos
Madrid, España IQVIA A tiempo completoAre you looking for an opportunity in Clinical Research? Do you want to work for an industry leading company. If so, come and join us - IQVIA are looking for a Clinical Research Assistant. This part-time (20 hours) role, is planned for 11 months and is to support the site inPalma de Mallorca in conducting a clinical trial in the field of cardiology. As a...
-
Clinical Research Coordinator
hace 3 días
Madrid, Madrid, España IQVIA A tiempo completoAre you looking for an opportunity in Clinical Research? Do you want to work for an industry leading company. If so, come and join us - IQVIA are looking for a Clinical Research Coordinator.This part-time (24 hours) role, is planned for 11 months and is to support the site in Majadahonda in conducting a clinical trial in the field of Cardiology .As a pivotal...
-
Site Manager
hace 4 días
Madrid, España Johnson And Johnson A tiempo completoPosition Summary: A Site Manager I (SM I) serves as the primary contact point between the Sponsor and the Investigational Site. A Site Manager I is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations...
-
Sr. Site Manager Ed&cp
hace 1 mes
Madrid, España Johnson & Johnson A tiempo completo**Global Clinical Operations (GCO)** **Position Title: ED&CP Site Manager II** **(4 positions available)** **Position Summary**: **Principal Responsibilities**: 1. Participates in site assessments, conducts pre-trial site assessment visits and/or participates to study feasibility assessments, providing recommendation from local area about...