In this role, you will perform and supervise study startup and site monitoring within global clinical research projects of novel pharmaceutics.
Office-based in Bangalore
You will:
- Monitor project timelines and patient enrollment, implements respective corrective and preventive measures
- Act as the main line of communication between the Sponsor, Project Manager and sites for systemic protocol-related updates
- Be involved in clinical site monitoring and management activities
- Coordinate investigator/ site feasibility and identification process
- Coordinates study startup
- Review IP-RED/ site regulatory packages
- Review monitoring visit reports for all visit types and ensures reporting compliance of CRAs
- Manage CRAs in the query resolution process, including Central Monitoring observations
- Coordinate safety information flow and protocol/process deviation reporting
- Perform clinical supplies management with vendors
- Ensure study-specific and corporate tracking systems are updated in a timely manner
- Conduct supervised monitoring visits in the projects
- Provide project-specific training to project teams and prepare training materials for the project teams
- Manage the project team in site contracting and payments
- Lead project team calls on a country level
- Provide status updates and reports to Regional Lead/ Project Manager
- Deliver trainings and presentations at Investigator Meetings, conduct project specific trainings of Investigators
- Supervise Site Management Associates in maintaining tracking systems, document and laboratory supplies flow
- Conduct site audit preparation visits, may participate in site audits, and coordinate resolution of site audit findings
- College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
- Participation in clinical projects as a Lead/Senior Monitor
- Independent on-site monitoring experience in India
- Full working proficiency in English
- PC skills to be able to work with MS Word, Excel and PowerPoint
- Ability to plan, multitask and work in a dynamic team environment
- Communication, leadership, and problem-solving skills
- Ability to travel
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.
