Swetha Ponnambalam
Associate Consultant
Bangalore
Summary
Clinical research professional with 7 years of experience across various domains such as clinical trial operations & monitoring, clinical study documentation management and medical writing with additional experience in patient centered research focused on clinical outcomes assessment.
Overview
11
11
years of professional experience
4
4
years of post-secondary education
Work History
Associate- Scientific Writing
Eli Lilly & Company
07.2023 - Current
- Develop regulatory documents for Phase 2-4 clinical trials- Clinical Trial Protocol including amendments and addendum, Informed Consent Documents and Assents.
- Perform peer review of documents developed by other writers
- Communicate and coordinate with various functions and stakeholders towards development of clinical study documents.
- Serve as subject matter expert for developing consent documents and lead consent documents focused group
Associate Consultant
IQVIA
10.2021 - Current
- Conduct Targeted Literature Reviews (TLRs) for identification of qualitative studies focused on patient reported outcomes and health-related quality of life.
- Conduct research in clinical trial registries, regulatory agencies and Health Technology Assessment agencies for identification and review of clinical outcomes assessment measures.
- Identify clinical outcomes assessments including type and use in specific diseases.
- Curate content for Clinical Outcomes Assessment Accelerator (COAA)- A platform that facilitates discovery of appropriate concepts, instruments, and endpoints to use in clinical studies with speed and scientific rigor.
- Curated content for concepts, instruments (Patient reported outcomes (PROs), Clinician reported outcomes (ClinROs), stakeholder evaluation records for over 10 therapeutic indications (Oncology, Gastrointestinal disorders, Nutrition disorders).
- As data monitor, perform quality check of content curated in COAA platform.
- Develop work instructions and process documents for specific process/modules in COAA.
Junior Medical Writer and Reviewer
JSS Medical Research Asia Pacific Private Limited
09.2020 - 09.2021
- Develop regulatory documents for Phase 2/3 clinical trials- Clinical Trial Protocol, Informed Consent Document, Clinical Study Report
- Perform quality check of documents developed by other medical writers to ensure compliance with regulatory guidelines and other applicable SOPs
- Coordinate with various departments towards development of clinical study documents.
- Actively participate in development of SOPs during SOP revision cycles
- Train and mentor new joiners on document writing and development
- Communicate with clients during document development and submission
Biomedical Engineer/Clinical Trial Assistant
JSS Medical Research Asia Pacific Private Limited
02.2017 - 09.2020
- Perform titration of device under study, Device accountability, handle device related complaints
- Ensure studies are conducted according to study protocol, ICH GCP guidelines and other applicable regulatory requirements.
- Liaise with sponsor and other stakeholders and Assist monitors and clinical trial sites on patient recruitment, retention and monitoring of clinical trial data
- Prepared dossiers for Regulatory and Ethics Committee submission for various phase 2/3 studies including COVID-19 studies
- Validate data entered in Electronic Data Capture platforms and assist sites with query resolution
- Collect and manage Clinical Trial documents (e-TMF management-Veeva Vault)
- Managed e-TMF for a global study with more than 10 study centers
- Develop CAPA for trial related issues/findings based on sponsor/regulatory audits
- Maintained strict adherence to laboratory guidelines and regulations, verifying safety and protective procedures
Programmer Analyst Trainee
Cognizant
10.2013 - 08.2014
- Analyzed customer needs to create and implement appropriate solutions (Vertical: Insurance)
- Reviewed and tested defect tickets
- Application support and maintenance
Education
PG Diploma - Clinical Research
Apollo Hospitals Educational & Research Foundation
Chennai 07.2015 - 02.2016
Bachelor of Engineering - Biomedical Engineering
SSN College of Engineering
Chennai 08.2009 - 05.2013
Skills
Clinical Research
Clinical study management
Clinical study documents management
Medical Writing
Clinical Outcomes Assessment
Targeted Literature Review
Patient Centered Research
Timeline
Associate- Scientific Writing
Eli Lilly & Company
07.2023 - Current
Associate Consultant
IQVIA
10.2021 - Current
Junior Medical Writer and Reviewer
JSS Medical Research Asia Pacific Private Limited
09.2020 - 09.2021
Biomedical Engineer/Clinical Trial Assistant
JSS Medical Research Asia Pacific Private Limited
02.2017 - 09.2020
PG Diploma - Clinical Research
Apollo Hospitals Educational & Research Foundation
07.2015 - 02.2016
Programmer Analyst Trainee
Cognizant
10.2013 - 08.2014
Bachelor of Engineering - Biomedical Engineering
SSN College of Engineering
08.2009 - 05.2013