Ref #: 29269

Employment type: Permanent - Full-Time

Location: Taipei, Taiwan

Posted: 19-May-2021

Description

If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance. We are hiring a Clinical Research Associate I to work closely with our client, a leading pharmaceutical company.


Overview
- As a Local Trial Manager (LTM) you will coordinate all aspects of the clinical monitoring and site management process in accordance with regulatory guidelines, local regulations and standard operating procedures. In this role you will be a decision maker, solving problems independently or as part of the client and ICON team.
- You will be managing competing priorities, supporting the on-site team, ensuring investigators follow the clinical trial protocol, providing training, and most importantly, motivating the team to ensure high quality results.


Key responsibilities
- (Based on Regional or Country Practices official titles will vary for this level) Performs the role of Local Trial Manager (LTM) including operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents.
- LTM is a person within Trial Co-ordination and Site Management responsible for local management of a trial (or Medical Affairs data generation activities) in a country or countries. The LTM is the primary point of contact at a country level for assigned studies.
- The LTM is responsible for coordinating and leading the local trial team in order to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements. LTM actively contributes to process improvement; training and mentoring of Clinical Trial Assistants Site Managers and LTMs. The LTM may have some site management responsibilities. An LTM I usually performs principal responsibilities under the direct supervision of an LTM II or III and/or Functional Manager.


Required experience and qualifications
- Specific therapeutic area experience may be required depending on the position. Should have basic understanding of the drug development process including ICH/GCP and local regulatory requirements.
- Solid communication and computer skills required.
- Proficient in speaking and writing the country language and English language. Good written and oral communication skills
- At least 2yrs as a PM position in global pharma & CRO insourced model in the company.


Why join the DOCS team at ICON?
Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.

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