Project Lead

Parexel International Corporation

South Korea - Any Region - Home Based

Working at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.

In the capacity of Project Lead at our sponsor’s organization, you will contribute to global drug development ensuring that all clinical projects are well planned, conducted and reported in accordance with international guidelines such as ICH GCP, company guidance as well as relevant local regulations.

Some specifics about this role

The project leader will:

· collaborate with study teams

· support or perform clinical study feasibility

· contribute to the selection of and negotiation with CROs

· coordinate the process for the selection of potential investigators

· oversee site evaluation/selection, contracts/budget negotiation, regulatory/EC submissions start up, issue management, relationship management, monitoring and site closure according to assigned role and responsibilities in each project.

· review and manage for the label of investigational product

· participate in initiation meetings

· perform regular quality oversight visits

· proactively monitor study conduct and progress

· review of documents for submissions to regulatory authorities

QualificationsHere 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

• Senior CRA 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

2022-06-24 00:05:23

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