Novartis (Thailand) Limited

Clinical Research Associate (1 Position)

Novartis (Thailand) Limited
Posted on 2-May-21

Clinical Research Associate (1 Position)

Novartis (Thailand) Limited

Job Highlights

  • Degree in scientific or healthcare discipline
  • At least 2 years of experience
  • Fluent in both written and spoken English

Job Description

Trial Monitoring  – Global Drug Development
Reports to: Clinical Research Associate Manager

To perform monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials within the country. To deliver data within timelines and required quality standard, and be responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.
  • Conduct site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommend sites to participate in clinical trial
  • Be the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries
  • Manage assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures
  • Perform Site Initiation Visit, ensure site personnel is fully trained on all trial related aspects. Perform continuous training for amendments and new site personnel as required. Retrain site personnel as appropriate
  • Conduct continuous monitoring activities (onsite and remote). Implement site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety
  • Be accountable for continuously updating all electronic systems (global and local) relevant to perform job functions
  • Ensure that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
  • Perform Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements
  • Attend onboarding, disease indication and project specific training and general CRA training as required  
  • Documents monitoring activities appropriately following Novartis standards
  • Collaborate with the CRA Manager/CSM to ensure recruitment plans and execute contingency plans, as needed
  • Participate from audit organization and inspection readiness activities for monitoring and site related activities as required and ensure implementation of corrective actions within specified timelines
  • Perform additional task as assigned
  • Monitor studies as per current legislations, ICH/GCP and Novartis standards
  • Ensure timely delivery, high quality, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring.
  • Identify issues at sites; resolves issues and escalate as appropriate
  • Collaborate with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry
  • Ensure the site Investigator Folder is up to date. Be responsible for collecting essential documents from site and accountable to keep sTMF(s) current.
  • Support the implementation of innovative processes and technologies
  • Negotiate investigator remuneration; prepare financial contracts between Novartis and investigational sites and investigators. Ensure that payments are appropriately triggered to investigational sites
You need:
  • Degree in scientific or healthcare discipline
  • At least 2 years of experience in pharmaceutical industry or other relevant experience,  monitoring experience is desirable
  • Fluent in both written and spoken English, local language
  • Good knowledge of drug development process specifically clinical trial/research
  • Knowledge of international standards (GCP/ICH, FDA, EMEA)
  • Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings, a minimum of 50% overnight travel may be required.
  • Good communication skills, ability to influence others,  excellent communicator and presenter (oral and written), ability to communicate to Sr. Leaders
  • Advanced data accuracy: ability to work focused with a great attention to detail
  • Good strategic thinking: ability to anticipate potential issues and take appropriate actions with or without supervision
  • Ability to manage sites independently; proven ability to work independently with minimal supervision

Novartis (Thailand) Limited

689 Bhiraj Tower at EmQuartier 25th Fl., Sukhumvit Road,

North Klongton,Vadhana, Bangkok 10110, Thailand

Tel:02-080-0999

Additional Information

Career Level
Entry Level
Qualification
Degree
Years of Experience
2 years
Job Type
Full Time, Permanent

Company Overview

Why consider Novartis?

799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Additional Company Information

Industry
Medical/Pharmaceutical