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AKHILA WALAJA RAJENDRA PRASAD
Senior Regulatory & Start-Up Coordinator
Bengaluru,India
Summary
Skilled at preparing and submitting contract amendments during the Study start-up phase, performing quality control of the documents. Collaborated with internal and external teams to develop transparent, efficient processes. Offering 1 yr 5 mos experience in Regulatory & Start-Up and looking for a challenging new role.
Overview
1
1
year of professional experience
4
4
years of post-secondary education
3
3
Languages
Work History
Senior Regulatory & Start-Up Coordinator
IQVIA
Bengaluru, Karnataka
08.2020 - Current
- Preparing and completing Budget negotiation of the Amendments with sites due to various rationale for countries NA & LATAM , execution of the contracts and ensuring all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
- Performing Quality control of Amendments.
- Reviewing contracts for completeness & accuracy, and ensures that corrections are appropriately made and documented
- Providing support to Local RSU team in preparing contract amendments for ROW countries.
- Handled challenging situations with ease. (E.g., 'Handled complex budget consists of 14 Schedule of Assessments and decreased the turn around time to 2 days rather than utilizing standard business days of 5-10 days')
- Established and improved site communication faster in order to facilitate review and execution of amendment. (E.g., 'Communicated in Portuguese language with site to complete process and received token of appreciation from leadership team and this idea was discussed in workshop, same was implemented to team members in further site communications for LATAM countries.')
- Maintaining effective Project/Site communications and Collaborating with internal and external clients (RSU Leads, Clinical leads, Project Leads, Project Managers, IPAs, CRAs & Sponsor)
- Mentoring new team members
Education
Bachelor of Pharmacy -
Sree Vidyanikethan College of Pharmacy
Sree Sainath Nagar, Tirupati, Andhra Pradesh 51710 08.2015 - 04.2019
Skills
Regulatory guidelines
Creative thinking
Problem-solving
Time Management
Mentoring skills
Teamwork and Collaboration
Extremely quick learner
Software
Microsoft Excel
Honor & Award
Ovation Award
July 2021
Assigned with a complex request related to the Protocol Amendment which impacts the budget and gave my 100% Quality which was noticed by my SME, functional manager and received appreciation from the cRSU leadership team.
Timeline
Senior Regulatory & Start-Up Coordinator
IQVIA
08.2020 - Current
Bachelor of Pharmacy -
Sree Vidyanikethan College of Pharmacy
08.2015 - 04.2019