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Clinical Research Assoc II

Zoek Pin Navi Mumbai, Thane, Maharashtra

Permanent (Full time)

Posted 14 days ago

Company InfoTeva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!Job Description To ensure all assigned studies follows SOPs, GCP and applicable regulations. To do all regulatory/ethics submission as per timelines and to ensure regulatory documents are available, complete and current. In coordination with the project manager and/or medical monitor, perform study site selection visits. Participate in/conduct investigator’s meeting and site initiation visits. To perform regular monitoring visits to site To verify the case report forms and source data according to the monitoring plan To ensure site level metrics (. 100% IP accountability, 100% informed consent documentation etc.) are tracked and communicated as appropriate. Conduct site close out and assure appropriate archival of controlled documents. Resolve issues as they affect clinical plan timelines and quality to ensure achievement of goals and objectives at the site level. Work in liaison with the finance department in the organization and administration of financial payments to the investigators or relevant local institutions. Qualifications 5-7 years of experience with MSC clinical research/ / FunctionResearch & DevelopmentSub FunctionClinical Research

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