Sr Clinical Research Associate
Il y a 5 mois
**Senior Clinical Research Associate Reports to**: Head of Country operationsLocation: Field Based Position Summary The Senior Clinical Research Associate (Sr. CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local country team(s). The Sr.CRA works in close collaboration with other CRAs and the Country Operations Management (COM) Team to ensure that study commitments are achieved in a timely and efficient manner. The Sr.CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery and compliance of the study.The Sr.CRA is responsible for the selection, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with Alexion Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.A Sr.
CRA with demonstrated skillset and experience may take on additional responsibilities and tasks as needed (eg. Lead CRA, etc). Principal ResponsibilitiesAccountable For: Performing selection, initiation, interim monitoring and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP). If required, determines and discusses with SML the correct timing and type of visits.Driving performance at the sites.
Proactively identifying and ensuring timely resolution to studyrelated issues and escalates them as appropriate.Performing Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the CMP.Training, supporting and advising Investigators and site staff in study related matters, including Risk Based Quality Management (RBQM) principles. Confirming that site staff have completed and documented the required trainings appropriately, including ICHGCP training, prior to and for the duration of the study. Ensuring the sites are inspection ready at all times, including ISF/training documentation, PI oversight and overall compliance to the protocol and applicable regulations.Development of recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones. Document recruitment barriers and mitigation plans.Ensuring data query resolution in a timely manner.Ensure agreed monito
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Clinical Study Administrator, Country Operations
Il y a 3 mois
Levallois-Perret, France AstraZeneca Temps pleinSenior Clinical Study Administrator, Country Operations Management Location: Office Reports To: Head of Country Operations Resume du poste Le Senior Clinical Study Administrator, Country Operations Management (CSA) aide a la coordination des activites detude, du debut a lexecution et a la clture, au sein de la gestion des operations nationales (COM), afin...
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Apprentice Clinical Operations
Il y a 3 mois
Levallois-Perret, France AstraZeneca Temps plein**Alternant(e) Recherche CliniqueReports to**: Associate Director Country Operations Line ManagerLocation: LevalloisPerret Principales Responsabilites Rattache(e) au departement des Operations Cliniques FranceBeLux, en collaboration avec lAssociate Directeur Country Operations, vous participerez aux : Mission CTA (Clinical Trial Assistant)Mise a jour et...
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M&A and Strategic Partnerships Associate
il y a 3 semaines
Levallois-Perret, Île-de-France North Star Network Temps pleinAbout North Star Network North Star Network is a dynamic media company with a global reach, specializing in sports media brands and websites. We are a team of passionate sports enthusiasts dedicated to delivering high-quality content to our audience. Job Title: M&A and Partnerships Associate About the Role We are seeking a highly motivated and...
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Scientific Communication
il y a 1 jour
Levallois-Perret, France L'Oréal Groupe Temps pleinOur skin has always been the outward sign of our inner well-being, of our health . When we are not well, when illnesses damage us and stigmatize us, we lose all strength, all confidence, all beauty. This is the mission of L’Oréal Dermatological Beauty: “ - . “ This strength we give is the strength of all those who work with us, it is...
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Real Estate Development Project Associate
il y a 3 semaines
Levallois-Perret, Île-de-France BATIGERE Temps pleinAbout BATIGERE BATIGERE is a leading real estate development company with a strong commitment to sustainable and innovative projects. We are seeking a highly motivated and talented individual to join our team as a Real Estate Development Project Associate. Responsibilities Market Research & Analysis: Conduct in-depth research on real estate opportunities,...
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Apprentice Clinical Operation
Il y a 3 mois
Levallois-Perret, France AstraZeneca Temps plein**Alternant(e) Recherche CliniqueReports to**: Associate Director Country Operations Line ManagerLocation: LevalloisPerret Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of lifechanging medicines. As a leader...
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Medical Scientific Liaison, Ophthalmology
Il y a 3 mois
Levallois-Perret, France Astellas Pharma Europe Temps plein**About Astellas**: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and...
