Assist to achieve overall business goals of the unit by meeting AOP budgets assigned to Clinics and Bioanalytical department, in liaison with Senior Management
Coordinate for all project activities required for Generics and Brand/Specialty projects along with managing the team
Communicate and coordinate effectively with all stakeholders at all stages of assigned projects
Provide project updates regularly and monthly achievements to the Senior Management.
Ensure project milestones and timelines are met at 95% service level
Update biopharm managers regularly on status of the projects, receive their inputs, understand their concerns, mitigate risk and ensure smooth project execution.
Facilitate follow up meetings with stake holders for closing queries from quarterly biopharm meeting.
Escalate issues/concerns and ensure implementation of timely solutions
Coordinate for activities required for WTI (florida) support functions and Innovative projects
Motivating the team to achieve organizational goals.
Ensure availability of valid licenses/approvals to conduct the BA/BE studies.
Ensure valid internal study conduct letters availability for conduct of studies.
Ensure insurance for subjects enrolled in BA/BE and patient-based studies.
Collaborate with stake holders to obtain feasibility of BA/BE studies.
To execute projects contracts and ensure that all relevant approvals of project contract before start of the clinical phase.
Facilitate training and coordinate for all compliance related activities and global audits.
Your experience and qualifications
B.Pharm/ M.Pharm
Overall, 10 Years of experience relevant 5- 7 Years of experience into Project Mgmnt for Clinical Trials BA/BE Studies