Sneha Karthik
Bengaluru
Summary
Knowledgeable Business Analyst with proven track record in analyzing business needs and recommending effective solutions. Successfully led cross-functional teams to implement process improvements, resulting in enhanced operational efficiency. Demonstrated expertise in data analysis and stakeholder communication.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Senior Associate Business Analyst
Infosys
08.2022 - Current
- Was involved in Just in Time project
- Preparing the requirements and getting them finalized with all the stake holders
- Uploading the requirements in ALM & getting them signed and finalized in ALM
- Worked intensively on Medidata as System Admin
- Working as a Release Manager and managed varies releases across Medidata
- Working as L2 support team on service now
- Resolved various tickets & incidents within the time frame
- Ensured data accuracy and integrity through rigorous quality control measures during analysis phases.
- Actively participated in team meetings to share knowledge, exchange ideas, address challenges, and collaborate on potential solutions.
- Analyzed data to identify root causes of problems and recommend corrective actions.
- Created dashboards to monitor and track key performance indicators.
Associate Clinical Operations Specialist
Novartis Healthcare
05.2018 - 04.2022
- Study budget management
- Support Clinical Project Manager (CPM) ensuring accurate planning, tracking and reporting of study budget
- Perform Good receipt booking, as required
- Support in Vendors and monitoring partner coordination
- Support CPM in collecting key study information from external vendors and monitoring partners involved in study execution
- Ensure all data is reported to the Clinical Trial Team and available to customer
- As required, support in study related meeting set up and meeting minutes
- Study logistics
- Support set-up and maintenance of studies in Clinical Trial Management Systems (CTMS), under responsibility of COS or CPM as applicable: Update data, timelines, milestones, EC/HA authorizations, etc
- On an ongoing basis
- Support set-up and maintenance of Trial Master File (TMF): Ensuring that all key documents are present and filed as appropriate in TMF, under responsibility of COS or CPM as applicable
- Follow up with Clinical Trial Team at agreed frequency for TMF maintenance
- Track study progress, ensure CTMS and TMF are up to date, report to customer as per scope of work
- Address questions; escalate issues or critical findings to project lead (Sr.) CPM
- As applicable Support (Sr.) CPM in drug forecasting projections, keeping overview of drug availability at site and global level in collaboration with monitoring partner, drug supply management and other PLS functions
- Under responsibility of CPM as applicable compile study regulatory documents for submissions to competent authorities and ethics-committees in collaboration with other associated PLS, Novartis line functions and CRO Partners as required
- Champion the implementation of operational changes and transitions as required
- Key study deliverables and milestones achieved
- CTMS and TMF are up-to-date (HQ, Country and Site)
- External & internal customer satisfaction survey
- CSR Appendices preparation
Sr. Clinical Process Associate
IQVIA
01.2016 - 04.2018
- Study specific mailbox management
- Service Request (SR) creation
- Payments Batch Review
- E-Training compliance tracker for clinical team members
- Request for system Access for the clinical team members and site staff
- Preparing minutes of meeting for the weekly calls
- Vendor management including Investigator Portal Access, eCRF Inform Access, Infosario Access, QNet Access, QLabs Access and IWRS Access
- ETMF document uploading
- QLabs issues – follow up with the sites
- Cascading monthly newsletters to the sites
- Performing both site level and country level eTMF review
- Downloading source documents for Central Monitors
- CTMS Document tracking
- Responsible for documentation of centralized monitoring activities e.g
- Risk/issue(s) finding, escalation, tracking and resolution etc., during conduct of clinical trials etc
- Supporting in building overall efficiencies in clinical trial monitoring operations
Education
Masters of Pharmacy (M.Pharm) - Pharma Analysis & Quality Assurance
Royal college of Pharmacy & Health science
Berhampur, Odisha01.2016
Bachelors of Pharmacy -
Royal college of Pharmacy & Health science
Berhampur, Odisha01.2014
Skills
- Operations Management
- Release planning
- Forecasting and planning
- Excellent Communication
- Organizational Skills
- Active Listening
- Effective Communication
- Decision-Making
- Customer Communication
- Interpersonal Skills
- Risk Assessment
- Teamwork and Collaboration
- Operational Efficiency
Certification
- Cornerstone Core System Specialist [Oct 2024]
Timeline
Senior Associate Business Analyst
Infosys
08.2022 - Current
Associate Clinical Operations Specialist
Novartis Healthcare
05.2018 - 04.2022
Sr. Clinical Process Associate
IQVIA
01.2016 - 04.2018
Bachelors of Pharmacy -
Royal college of Pharmacy & Health science
Masters of Pharmacy (M.Pharm) - Pharma Analysis & Quality Assurance
Royal college of Pharmacy & Health science
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