Country Start-Up Specialist @ PRA International, Mumbai, Non Travelling In house Job, D5

Job description

We are currently looking for Country Start-up Specialist. As a member of the Clinical Operations team, you will be responsible for all aspects of the Clinical Start-Up activities at the country level to achieve successful activation of sites in accordance with ICH GCP, FDA regulations, applicable regulations and requirements, and SOPs. You will be working on a wide spectrum of projects in phase I-IV research at both GP practices and hospitals. Responsibilities will include:

• Being the main point of contact for all sites during the study start up process 
• Implement the start up methodology in a consistent way 
• Facilitate the transition of study activities to the CRA 
• Deliver training to Clinical Operations staff designated to start up activities 
• Provide oversight of local ethics committee submissions and Ministry of Health Submissions 
• Ensuring that all essential documents are developed, collected, reviewed and tracked effectively 

About the Company:

As the world’s fourth largest CRO, PRA is transforming clinical trials through our people, innovation and operational transparency. PRA has more than 10,000 employees in 80+ countries providing comprehensive clinical trial services across all phases. We have conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 40+ drugs marketed across several therapeutic areas.

By successfully implementing our strategic expansion and operational plans, PRA is positioned to meet the demands of a diverse and competitive marketplace. We utilize our Embedded staffing solutions, sophisticated technological systems and highly trained clinical teams to work on variety of compounds, ranging from niche treatments and therapies to blockbuster drugs. PRA clients further benefit from our strategic investment in key therapeutic programs and research areas, including neurology/psychiatry, oncology/hematology, biosimilar products and rare diseases.

Our dynamic services and forward-thinking approach to drug development programs are making a difference to healthcare patients worldwide.

Apply directly at company website