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Senior Clinical Research Associate - Real World & Late Phase - PORTUGAL

IQVIA Holdings Inc.

Lisbon, Portugal

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

IQVIA- Real World Evidence Solutions has exciting permanent career opportunities on offer for experienced CRAs in Portugal.

In IQVIA the Real World Evidencebusiness unit employs over 1,000 dedicated staff to design, implement and manage real-world and post-marketing studies. As healthcare stakeholders increasingly need evidence to support regulatory, reimbursement and prescribing decisions, the IQVIA RWE team offers a comprehensive evidence approach to meet our customer’s unique needs for demonstrating safety, effectiveness and quality. As a CRA, you will be part of an outstanding international team managing Low Interventional and Observational trials.

RESPONSABILITIES

  • Perform site selection, start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices applicable regulations, SOPs and work instructions.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to international Clinical Project Manager (CPM), Site Management Lead (SML) and/or line manager.
  • Manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans.

REQUIREMENTS

  • Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Strong written and verbal communication skills in Portuguese & English
  • Good organizational, interpersonal and problem-solving skills
  • Strong attention to detail
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients and site personnel at assigned sites
  • Bachelor’s Degree preferably in life science
  • Minimum 2 years on independent monitoring experice
  • Oncology experience is an advantage

WHAT WE OFFER

  • At IQVIA you have the opportunity to make a lasting impact on our customers, the industry, patient health around the world, and your career.
  • The chance to work on cutting edge medicines right at the forefront of drug development
  • Gnuine career development opportunities for those who want to grow as part of the organization
  • Excellent salary and benefits package
  • Flexible working hours in a home-based role open to different locations

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

Job posted: 2020-06-09

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