Covance

Clinical Team Lead

Job Location(s) TW
Job Number
2018-17505
Job Category
Clinical Operations
Position Type
Full-Time

Job Overview

We are hiring Clinical Team Lead (Project Management).

Are you an experienced Lead CRA or Clinical Lead based in Taipei, Taiwan that has regional project management experience and would like to expand your expertise in project management?

Our Flexible Solutions Clinical Team Lead will be based at our pharmaceutical client sites and responsible for project manager and leading CRA in project base.

 

Responsibilities

  • Develop and maintain relationships within client
  • Requests, manages and tracks clinical project resource needs
  • Participates in project review meetings and provides operational and regulatory maintenance updates to the affiliate management team and Research Director, as well as Headquarters;
  • Ensures that all clinical operations staff allocated to assigned projects adhere to professional standards, ICH/GCP guidelines, project plans and SOPs;

 

About Covance:

Covance is one of the world’s largest and most comprehensive drug development services companies, with more than 13,000 employees in 60 countries. We began operations Asia Pacific in 1988 and today have more than 1000 employees in 14 countries across the region. Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.

Why Covance?

At Covance, you will join like-minded collaborative professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.

Discover your potential in a company that truly invests in you. Talk to us to learn more and explore your career. Apply online today.

Education/Qualifications

• University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution;

• In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered;

• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries;

• Thorough understanding of the drug development process.

 

Preferred

  • PMP Qualification
  • Oncology project experience

Experience

Regional Project Manager experience in a Clinical Research Setting.

• An ability to demonstrate comprehensive understanding of:

-ICH/GCP guidelines;

- Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs;

- Site monitoring and study site management requirements;

- Applicable regional regulatory requirements;

- Trip report review, risk planning, study plan development, resource planning and data management oversight;

-In lieu of the above requirements, candidates with 2 years supervisory experience in a health care setting and four 4 years clinical research experience (including monitoring) in the pharmaceutical or CRO industries will be considered.

Preferred

• Experience as a Senior Clinical Research Associate;

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