Assoc Dir Clinical Research

Company Info

Teva 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

• •  
•  Review overall functioning of all the clinical facility to ensure compliance to protocol, SOP, GCP and regulatory requirements and overall responsibility for the functioning of Clinical Department.
• Review of SOPs for regulatory compliance & feasibility of implementation.
• Determine feasibility to conduct Clinical studies along with the principal investigator and clinical investigator.
• Planning studies schedule with Project Management Group, and planning of study conduct with principal and clinical investigators
• To ensure protocols are reviewed by Principal Investigators for scientific soundness, regulatory and SOP compliance.
• Identify resources required for the smooth functioning of the clinical department including infrastructure, manpower and systems; also ensure that these are in compliance with regulatory requirements.
• Ensure that all personnel in the clinical department are trained in GCP, relevant SOPs and relevant job specific procedures.
• Review AEs and SAE's with Investigators.
• Ensure the rights & well-being of study subjects are safeguarded in coordination with ethics committees.
• Facilitate client audits and ensure appropriate resolution of client and regulatory queries.
•  Follow up of revision of SOPs with relevant personnel and to ensure SOPs are revised on time.
•  Timely review and resolution of audit reports with relevant personnel.

Qualifications

MBBS with 10+ years of experience

Function

Sub Function

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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.