Sr. Scientist / ASM I Clinical Operations
Job Description
1. To oversee and coordinate clinical trials conduct by providing overall operational support
2. Selection and assessment of potential CROs and vendors for conducting clinical trails
3. To participate in budget negotiations with CROs and other vendors
4. To participate in preparation/review of clinical trial documents
5. Monitor progress of trial and timelines as per the milestones and implement appropriate action plans in case of delays
6. Oversees the trial to ensure adherence to Good Clinical Practices and maintain quality standards in accordance to applicable regulatory requirements, Declaration of Helsinki, applicable guidelines, SOPs and Protocol
7. Co-ordiate wit cross functional team for various trial activites
Company Profile
2. Selection and assessment of potential CROs and vendors for conducting clinical trails
3. To participate in budget negotiations with CROs and other vendors
4. To participate in preparation/review of clinical trial documents
5. Monitor progress of trial and timelines as per the milestones and implement appropriate action plans in case of delays
6. Oversees the trial to ensure adherence to Good Clinical Practices and maintain quality standards in accordance to applicable regulatory requirements, Declaration of Helsinki, applicable guidelines, SOPs and Protocol
7. Co-ordiate wit cross functional team for various trial activites
Company Profile
Biocon is an integrated biotechnology enterprise focused on the development of biopharmaceuticals. With successful initiatives in drug discovery and development, bioprocessing, manufacturing and global marketing, Biocon delivers products and solutions to partners and customers in over 75 countries. Biocon has the defining science, world class capabilities and a focused vision to deliver the promise of innovative and affordable medicine to a waiting world. Today, Biocon together with group companies employs more than 5000 employees with approxmimately Rs 2500 crore turnover and is expected to grow further during the current financial year .