Ref #: 35511
Employment type: Permanent - Full-Time
Location: Taiwan, Home based
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 "Local Trial Manager/Sr." 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.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
#CRAJob
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.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
#CRAJob