Clinical Research Assoc II

　　Date: Jan 23, 2024

　　Location:

　　Bangalore, India, 560064

　　Company: Teva Pharmaceuticals

　　Job Id: 53544

　　Who we are

　　Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

　　The opportunity

　　The CRA conducts central monitoring based on eTMF/ CTMS documents in study database TGEC. The CRA supports Clinical Study Managers, CSOM and Manager Clinical Research in eTMF maintenance and quality control procedures and central monitoring activities for PD/CE and Biosimilar studies. The CRA might be involved in non-study related activities depending of the needs in the department.

　　Your experience and qualifications

　　Education medical information management or equivalent qualification, or Clinical Research Associate training

　　3 years of relevant pharmaceutical industry experience and GCP-training is beneficial.

　　How you’ll spend your day

　　Performs Central Monitoring for clinical study/trial of the eTMF/ CTMS documents in study database TGEC to ensure GxP compliance of study conduct by contract research organizations/vendors in accordance with SOPs and checklists.

　　Supports maintenance and quality control procedures of essential documents of eTMF/ CTMS documents in study database TGEC for clinical study/trial according to ICH-GCP and other study-related documents according to TMF plans/EDLs and SOPs/BPGs

　　Supports knowledge collection on TMF maintenance/study documents collection and documentation

　　Key contact for study managers on central monitoring questions

　　Supports to Manager Clinical Research and CSOM/CSM

　　Reports to Manager Clinical Research

　　Teva’s Equal Employment Opportunity Commitment

　　Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

　　EOE including disability/veteran