Senior Clinical Research Associate

il y a 3 semaines

LevalloisPerret, France Alexion Pharmaceuticals,Inc. Temps plein

Location: Levallois-Perret, France

Job reference: R-185391

Date posted: 11/22/2023

**Senior Clinical Research Associate**

**Reports To**:
Associate Director Country Operations Line Manager

**This is what you will do**:
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 ICH-GCP, 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 (e.g. Lead CRA, etc).

**You will be responsible 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).
- Driving performance at the sites. Proactively identifying and ensuring timely resolution to study-related issues and escalates them as appropriate.
- Training, supporting, and advising Investigators and site staff in study related matters, including Risk Based Quality Management (RBQM) principles.
- 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.
- Ensure agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (Action Items aging, SDV metrics, Data entry metrics, query aging, MV reports metrics, etc.)
- Preparing and finalizing monitoring visit reports in CTMS and provide timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with Alexion SOPs.
- Ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Alexion SOPs and local requirements. Supporting/participating in regular QC checks of the eTMF
- Contributing to the nomination and selection of potential investigators and assisting with feasibility activities
- Collaborating with local Medical Affairs and other internal stakeholders, as needed.
- Following quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICH-GCP compliance issues to SLCO, SML, PMCO and/or Quality Group as required.
- Preparing for and collaborating with the activities associated with audits and regulatory inspections in liaison with SML and Quality Group.

**You will need to have**:

- Minimum of 4 years of CRA monitoring experience
- Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification
- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
- Excellent knowledge of relevant local regulations.
- Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas.
- Good understanding of the drug development process.
- Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management.
- Excellent attention to details.
- Excellent written and verbal communication skills.
- Excellent collaboration and interpersonal skills.
- Good negotiation skills.
- Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70% during busy periods)
- Valid driving license (*)
- to be deleted if not required in a country.
- (*) to be adapted to local country market needs. Solid knowledge of clinical development processes with strong emphasis on monitoring
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

**We would prefer for you to have**:

- Ability to work in an environment of remote collaborators and in a matrix reporting structure
- Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.
- Ability to look for and champion more efficient and effective methods/pro

  • Sr Clinical Research Associate

    Il y a 2 mois

    Levallois-Perret, France AstraZeneca Temps plein

    **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...

  • Senior Clinical Study Administrator, Country

    il y a 3 jours

    Levallois-Perret, France Alexion Pharmaceuticals,Inc. Temps plein

    Location: Levallois-Perret, France Job reference: R-198112 Date posted: 04/24/2024 **Senior Clinical Study Administrator,** **Country Operations Management** **This is what you will do**: The Clinical Study Administrator (CSA) assists in the coordination of study activities from the start up to execution and close out within Country Operations...

  • Senior Clinical Study Administrator, Country Operations Management

    il y a 4 semaines

    Levallois-Perret, France Alexion Pharmaceuticals Temps plein

    Senior Clinical Study Administrator, Country Operations Management This is what you will do: The Clinical Study Administrator (CSA) assists in the coordination of study activities from the start up to execution and close out within Country Operations Management (COM) to ensure quality and consistency of trial deliverables to time, cost and quality...

  • Clinical Study Administrator, Country Operations

    Il y a 2 mois

    Levallois-Perret, France AstraZeneca Temps plein

    Senior 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...

  • Clinical Study Administrator, Country Operations

    il y a 2 jours

    Levallois-Perret, Île-de-France AstraZeneca Temps plein

    Senior 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...

  • Quality Assistant Market Research/ Rwe

    il y a 2 semaines

    Levallois-Perret, France IVIDATA Life Sciences Temps plein

    Ividata Life Sciences is the subsidiary of the Ividata group, which has been supporting healthcare manufacturers throughout France since 2013, focusing on scientific, technical and operational issues. Our employees and experts are involved in clinical operations, biometrics & data science, pharmacovigilance, regulatory affairs and quality assurance. Our...

  • Senior Research Manager

    il y a 2 semaines

    Levallois-Perret, France Metrixlab Temps plein

    **Êtes-vous naturellement curieux ?** **Vous êtes à la recherche d'un rôle enrichissant dans une entreprise qui évolue et se développe rapidement ?** **Vous essayez de trouver une équipe soudée, amusante et solidaire ?** **Rejoignez MetrixLab.** **MetrixLab est un institut d'études marketing international, experts en santé de marque,...

  • Apprentice Clinical Operations

    Il y a 2 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...

  • Senior Director, Head of Country Operations

    il y a 2 semaines

    Levallois-Perret, France Alexion Pharmaceuticals Temps plein

    Senior Director, Head of Country Operations Location: Levallois Perret Reports To: Regional Head of Country Operations (RHCO) This is what you will do: The Senior Director Head of Country Operations (SDHCO) will build and lead a local country team, fully accountable for country execution of clinical trials, all associated study deliverables,...

  • Research Manager

    Il y a 2 mois

    Levallois-Perret, France MetrixLab Temps plein

    **Chargée d'étude Sénior - Paris** Êtes-vous naturellement curieux ? Vous êtes à la recherche d'un rôle enrichissant dans une entreprise qui évolue et se développe rapidement ? Vous recherchez un environnement de travail stimulant, au sein d’une équipe soudée, amusante et solidaire ? Rejoignez MetrixLab. MetrixLab est un institut d'études...

  • Assistant Qualité

    il y a 2 semaines

    Levallois-Perret, France IVIDATA Life Sciences Temps plein

    Ividata Life Sciences is the subsidiary of the Ividata group, which has been supporting healthcare manufacturers throughout France since 2013, focusing on scientific, technical and operational issues. Our employees and experts are involved in clinical operations, biometrics & data science, pharmacovigilance, regulatory affairs and quality assurance. Our...

  • Senior Manager, Study Start Up

    il y a 4 semaines

    Levallois-Perret, France Alexion Pharmaceuticals Temps plein

    This is what you will do: The Study Start-up (SSU) Senior Manager has local/country responsibility for the delivery of site start up activities for assigned studies and is a member of local study team(s). The SSU Senior Manager works in close collaboration with CRAs, PMCO, Supporting functions,, study sites and the Clinical Trial Team (CTT) to ensure...

  • Senior Manager, Study Start Up

    il y a 2 semaines

    Levallois-Perret, France Alexion Pharmaceuticals Temps plein

    This is what you will do: The Study Start-up (SSU) Senior Manager has local/country responsibility for the delivery of site start up activities for assigned studies and is a member of local study team(s). The SSU Senior Manager works in close collaboration with CRAs, PMCO, Supporting functions,, study sites and the Clinical Trial Team (CTT) to ensure...

  • Reconversion - Assistant Marketing

    Il y a 2 mois

    Levallois-Perret, France PROFILE RESEARCH Temps plein

    **Expert en recrutement, PROFILE RESEARCH a pour vocation de répondre à l’ensemble des besoins en compétences fonctionnelles et techniques des entreprises. Nos solutions RH personnalisées, PLACEMENT CDI / CDD et INTERIM EXPERT, accompagnent les recrutements de Collaborateurs Cadres et Non-Cadres, Temporaires et Permanents, Juniors à Seniors.*** Rôle...

  • Reconversion - Assistant Marketing

    il y a 2 jours

    Levallois-Perret, Île-de-France PROFILE RESEARCH Temps plein

    **Expert en recrutement, PROFILE RESEARCH a pour vocation de répondre à l'ensemble des besoins en compétences fonctionnelles et techniques des entreprises. Nos solutions RH personnalisées, PLACEMENT CDI / CDD et INTERIM EXPERT, accompagnent les recrutements de Collaborateurs Cadres et Non-Cadres, Temporaires et Permanents, Juniors à Seniors.***Rôle &...

  • Research Jumpstart Executive

    il y a 4 jours

    Levallois-Perret, France Toluna Temps plein

    **Research JumpStart Executive** **Vincennes/Levallois, France** **APPEL A TOUS LES DIPLOMÉS!** Saviez-vous que les insights consommateurs font tourner le monde ? Il n'y a pas une publicité, programme télévisé, film, service de streaming, nouvelle saveur de chocolat ou le dernier restaurant en vogue qui n'ait pas fait l'objet d'une étude marketing...

  • Research Coordinator

    il y a 2 semaines

    Levallois-Perret, France International SOS Temps plein

    About the company International SOS is the world’s leading medical and security services company with over 12,000 employees working in 1,000 locations in 90 countries. Established 35 years ago, we have become the market leader in global telehealth services and digital health solutions for an extensive client base of Fortune 500 companies, NGO’s...

  • Research JumpStart Executive

    il y a 4 jours

    Levallois-Perret, France Harris Interactive Temps plein

    APPEL A TOUS LES DIPLOMÉS !Saviez-vous que les insights consommateurs font tourner le monde ? Il n'y a pas une publicité, programme télévisé, film, service de streaming, nouvelle saveur de chocolat ou le dernier restaurant en vogue qui n'ait pas fait l'objet d'une étude marketing avant d'être lancé ! Nos clients (comme TikTok, Disney, Dove et...

  • Medical Science Liaison Belux

    il y a 3 semaines

    Levallois-Perret, France Alexion Pharmaceuticals,Inc. Temps plein

    Location: Levallois-Perret, France Job reference: R-201176 Date posted: 05/31/2024 **Medical Science Liaison Belux** **Location**: Brussels, Belgium **Reports To**: Associate Director, Medical Affairs Belgium **This is what you will do**: The Medical Science Liaison (MSL) is a field-based scientific expert that strategically supports the medical and...

  • Medical Science Liaison Belux

    il y a 2 jours

    Levallois-Perret, Île-de-France Alexion Pharmaceuticals,Inc. Temps plein

    Location: Levallois-Perret, FranceJob reference: R-201176Date posted: 05/31/2024Medical Science Liaison BeluxLocation:Brussels, BelgiumReports To:Associate Director, Medical Affairs BelgiumThis is what you will do:The Medical Science Liaison (MSL) is a field-based scientific expert that strategically supports the medical and scientific objectives of...