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Jobs at Parexel

We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it With Heart ™.

Project Lead (FSP)

Job ID R0000003299 Korea, Republic of, Remote

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

You are required to contribute to the global drug development and regulatory PMS, ensuring that all clinical studies/projects assigned to you are well planned, conducted and reported in accordance with international guidelines such as ICH-GCP, company’s SOP/guidelines as well as relevant local regulations.

Some specifics about this role

Global Clinical Research Area:

  • Collaborating closely with study team on full project management including clinical feasibility studies, selection of CROs/PIs/sites, contracts/budget negotiation, regulatory/EC submissions, site relationship management and site closure based on assigned projects’ needs.
  • Participating in initiation meeting to ensure CROs provide appropriate training to site staff and implement appropriate procedure
  • Perform regular quality oversights visits with Study Team or alone and prepare oversight visit report on a timely basis
  • Review and manage the label of investigational product
  • Review applications/documents for submissions to regulatory authorities and monitor clinical trial applications to obtain rapid approval for trial commencement

Administrative Area in Medical Division:

  • Plan and manage budget for assigned projects in accordance with compliance program and internal SOP
  • Generate and revise internal local SOP in aligned with current activities
  • Provide information and regular updates to CD team leader and other related departments on on-going/planned clinical studies/projects

Here are a few requirements specific to this role:

  • Bachelor degree or above, major in pharmacy or health science related background.
  • Excellent knowledge of ICH-GCP and local relevant regulations regarding safety reporting and promotional guide
  • CRA II candidates with project management skills preferred.
  • Good command of English (both written and spoken)
  • Good presentation, communication and interpersonal skills
  • Good change and conflict management skills; able to identify issues and resolve problem efficiently
  • Open to 3-day office-based work arrangement at Central Seoul
  • This is a 18-month contract role

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