Shilpa Chandrasekaran
Chesterfield
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
17
17
years of professional experience
Work History
Sr. Clincal Study Start-up Associate
Novo Nordisk
06.2022 - Current
- Drives and tracks site activation, start-up activities with clinical trial sites to support trial start-up strategies
- Adaptive to study demands and offer expertise and support to sites and CRAs
- Acquired external vendor relationship experience with Calyx and Clario imaging partners
- Very strong collaboration and communication with internal and external stake holders
- Buddy other CSSAs to train and develop within the department on the CSSA Role
- Provide system and device expertise to train and support clinical trial sites
- Provide support to prepare for and follow-up on audits and inspections
- Demonstrates technical expertise as a Sr
- CSSA, staying current of new practices and building knowledge of emerging trends and advances within area
- Achieved database locks and assisted EDL reviews, CONNECT portal trial closure.
Senior Associate Document Manager (SADM)
Novo Nordisk
01.2020 - 07.2022
In House CRA/Clinical Site Start up Associate
Novo Nordisk
10.2012 - 06.2022
- Provides strategic and tactical leadership to local Clinical Site Lead and other stakeholder members to drive the successful delivery of studies within the clinical trial portfolio
- Collaborate with other cross functional departments to plan and deliver all relevant services/tasks to internal and external stake holders
- Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with NN SOPs, GCP and ICH Guidelines
- Create, maintain, distribute information on CIOMS reports to clinical trial sites and IRBs, protocol deviations, summarizes feasibility information and provides to study team
- Generate and maintain site specific document trackers to track document transfer process and audit purposes.
Clinical Trial Associate
Novo Nordisk
11.2014 - 02.2018
Senior Business Support Coordinator
Novo Nordisk
10.2012 - 10.2014
Senior Clinical Project Associate
Covance
07.2007 - 10.2012
- Processed study documents in accordance with client and study requirements, participated in client and/or audits and document archiving activities as necessary, and participated in training related to fulfillment of responsibilities as required by Company and/or the client
- Develop, track and report on study metrics
- Support project manager as needed in consolidation of feasibility questionnaire responses
- Create and maintain clinical study documents in assigned shared locations or central repository of document management systems for client and internal team access and have been a sole administrator for the maintenance of document management system
- Track study progress in CTMS including patient enrollment and site status
- Communicate with the sites through direct contact and other methods regarding study specific issues.
Education
Professional Experience Highlights
- 15 years of experience in clinical research
- Lead the start-up imaging qualification process for pediatric obesity trial
- Accompanied CRAs for on-site and phone visits
- Active participation in country calls with CDC-TM and internal meetings
- Initiated and achieved activation, FPFV on target for over 8 trials
- Oversee, proactively support sites for risk identification and mitigation
- Provide overall site/CRA support for protocol and other related questions and escalations
- Generate reports and compile key study information for site and CRA communication
- Cross functional collaboration with the other functional stakeholders
- Collaboration with external vendors to provide site trainings on their systems.
Additional Collaborations
- Continue to mentor with colleagues to foster my development at NNI as future clinical site lead
- Take on additional responsibilities to support study team and other stake holders for successful trial execution
- Start-up SME and New Hire trainer for Ancillary Supplies process
- COSMOS SME for initial roll out of the Veeva system.
Affiliations
Employee Resource Group (ERG) NASPAC
Awards
- Received Management and CRA recognition for dedicated site and study team support this year
- Received high ratings 'outstanding'& 'Exceeds Expectations' from external site survey -2021
- NASPAC ERG STAR Award winner for 3 consecutive years -2018,2019,2020
Timeline
Sr. Clincal Study Start-up Associate
Novo Nordisk
06.2022 - Current
Senior Associate Document Manager (SADM)
Novo Nordisk
01.2020 - 07.2022
Clinical Trial Associate
Novo Nordisk
11.2014 - 02.2018
In House CRA/Clinical Site Start up Associate
Novo Nordisk
10.2012 - 06.2022
Senior Business Support Coordinator
Novo Nordisk
10.2012 - 10.2014
Senior Clinical Project Associate
Covance
07.2007 - 10.2012
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