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  • Project Associate

    hace 1 semana


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    Job OverviewWe are seeking an experienced Clinical Project Associate to join our dynamic team. As a key member of our clinical operations team, you will play a vital role in supporting the delivery of our observational studies.Key Tasks and Responsibilities:Collaborate with the Project Manager/Project Director to manage project operations and...

Clinical Project Associate

hace 1 mes


Madrid, Madrid, España OXON Epidemiology A tiempo completo

OXON Epidemiology, a leading international CRO specializing in real-world data, is seeking a proactive Clinical Project Associate (PA) to join our Madrid-based team (residency in Madrid is preferred but not essential).

TO APPLY :

  • Send your CV and cover letter in English to , quoting the reference : 'Clinical Project Associate'. Only these applications will be considered.
  • Interviews with shortlisted candidates will be held in May 2025.

JOB DESCRIPTION

As a Clinical Project Associate, you will provide operational support in the day-to-day study / project management for national and international observational studies (EU, US, Asia).

While working together with the Project Manager, you will stay close to science and interact closely with epidemiologists, statisticians, data managers, EDC software developers, PV, as well the Operations group, being involved in innovative developments in observational research, such as hybrid field-database studies and pragmatic trials, with leading academics in London, Oxford, and other EU countries. Experience in a pharmaceutical company or a Clinical Research Organization (CRO) and fluency in English are essential.

MAIN DUTIES AND RESPONSIBILITIES

  • Support the Project Manager / Project Director in day-to-day project operations and deliverable oversight.
  • Help develop and implement project plans, timelines, and tracking systems.
  • Ensure study deliverables align with project goals and timelines.
  • Prepare and maintain project-specific documentation including study files, project management plans, communication plans, and monitoring plans.
  • Ensure study documentation complies with SOPs and records management procedures.
  • Facilitate effective communication among internal and external stakeholders.
  • Schedule, participate in, and document Sponsor, departmental, and project-specific meetings.
  • Ensure project team members have access to the necessary tools, systems, and study-specific training.
  • Support the allocation and availability of resources across different project phases.
  • Prepare and distribute regular project status reports for both internal and Sponsor review.
  • Track study progress and escalate issues or delays to the Project Manager.
  • Monitor and support CRA activities related to:
    • Regulatory document preparation and submissions.
    • Submissions to Ethics Committees and Competent Authorities.
    • Development and review of monitoring plans / guidelines.
    • Review and approval of monitoring visit reports.
    • Performance oversight and issue resolution.

REQUIREMENTS :

  • Bachelor's degree or equivalent qualification in a relevant life science discipline. A master's degree or equivalent experience is preferred.
  • A minimum of 4 years' experience in clinical operations in biopharmaceutical / medical device industry, including site management and monitoring. Prior experience in a Project Associate role is preferred.
  • Knowledge and experience working in international multi-country non-interventional studies / pharmacoepidemiological studies is an advantage.
  • International experience is preferred but not required.
  • Knowledge of ICH, GPP and GCP guidelines, as well as European regulations.
  • Ability to lead a cross-functional team in a matrix environment.
  • Excellent organizational and administrative skills, with strong prioritization and forward-planning abilities. Proactive, with a creative and solution-oriented mindset.
  • Good communication skills (oral and written) and interpersonal skills, ensuring professional communication.
  • Advanced computer skills including Office 365 (Word, PowerPoint, Excel) and other PM software.
  • Positive attitude with a solutions-oriented mindset.
  • Fluency in English (written and spoken) is essential.
  • Ability and willingness to travel up to 20% of the time.

WE OFFER :

  • Full-time, permanent contract.
  • Flexible timetable and remote / hybrid work options.
  • A competitive salary and benefits package.
  • Opportunities for professional development and growth.
  • Collaborative and inclusive work environment.

OXON EPIDEMIOLOGY is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We encourage applications from candidates of all backgrounds and do not discriminate based on race, gender, age, religion, disability, sexual orientation, or any other protected status. Join us in building a diverse and talented team

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