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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