Local Study Manager_Clinical Operations_MNC
Oversees &manages monitoring activities from site activation to site management
Opportunity to work with a fantastic growing team in Global MNC
About Our Client
The client is a MNC Pharmaceutical Innovator company with a strong pipeline of molecules. The Clinical Operations team is an ever evolving and expanding team.
- LSM is responsible to ensure that sites are identified, site qualifications performed, set up initiated, monitored, closed and documentation archived
LSM will be largely responsible for Project Management in Phase 2/3 Global trials
- LSM needs to come with strong exposure to the Indian market
- LSM is responsible for leading a team of CRAs, Snr CRAs
- Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
- Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment and conducting Site Qualification Visits to evaluate suitability and quality risks.
- Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
The Successful Applicant
- Candidate must be a Clinical Study Manager at present responsible for India for global phase 2/3 studies
- At least 3 years of experience in study management of phase 2/3 global clinical trials
- Strong background in clinical trial site monitoring
- Having worked with MNCs/ Top CROs in the past
- Excellent communication skills
- Strong understanding of India region
- Educational background: Pharmacy/Medicine
- Candidate can operate from Delhi/ Mumbai/ Bangalore
What's on Offer
An opportunity to be a part of a growing team and lead from the front
Excellent exposure into global practices of a reputed MNC
Flexibility to operate from any location