SHUBHANGI GODBOLE
Bangalore
Summary
A committed clinical research professional with a total experience of 5.9 years in clinical operations. Demonstrated ability to support management, drive remote teams and coordinate the tasks of multiple clinical research studies. Possess excellent communication skills and ability to present results in a clear and actionable format for investigators, sponsors, regulatory bodies or other consulting professionals.
Overview
6
6
years of professional experience
Work History
Global Site Activation Analyst
IQVIA
Bangalore
02.2024 - Current
- Company Overview: The human data science company, Bangalore, India
- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary
- Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines
- Perform start up and site activation activities according to applicable regulations, SOPs and work instructions
- Distribute completed documents to sites and internal project team members
- Prepare site regulatory documents, reviewing for completeness and accuracy
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information
- Review and provide feedback to management on site performance metrics
- Review, establish and agree on project planning and project timelines
- Ensure monitoring measures are in place and implement contingency plan as needed
- Inform team members of completion of regulatory and contractual documents for individual sites
- Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines
- Provide local expertise to SAMs and project team during initial and on-going project timeline planning
- Perform quality control of documents provided by sites
- May have direct contact with sponsors on specific initiatives
- The human data science company, Bangalore, India
- Working on projects: Breast Cancer phase-II, Metastatic cancer Phase-III, Malignant Lung Tumor Phase-II, Hematologic Malignancy Phase-II
Global Clinical Trial Assistant
IQVIA
Bangalore
11.2021 - 02.2024
- Company Overview: The human data science company, Bangalore, India
- Assist the sGTM in various phases of the study such as planning, maintenance and close out activities
- In start-up phase, support the sGTM in creating study specific folders
- Tracking the subject, site and visit status and milestones in CTMS/ sCTMS
- Assist the sGTM in preparing reports and trackers to track various metrics (electronic data capture report, action items, Protocol deviations etc.)
- Perform access management for the study team (CRA, SRS, SGTM, C-CRA)
- Project trainings- compliance reports, inclusion and withdrawal of eTrainings as notified by sGTMs
- Supporting sGTM in checking compliance for monitoring plans
- Support the clinical project team by accurately updating and maintaining clinical systems within project timelines
- Preparing, handling, distributing, filing, and archiving of clinical documentation and reports as per the scope of work and standard operating procedures
- Assist the sGTM in providing a periodic review of the prospective principal investigators to be selected for participation in the study
- To ensure that the CRA transition documentation is complete
- Assist with periodic review of study files for accuracy and completeness
- Perform close out activities for study in close out phase
- Perform administrative tasks to support team members with clinical trial execution as needed
- Perform eTMF tasks for each Milestones Triggers (Pre FPV, FPV-LPV, country CO and Study CO)
- The human data science company, Bangalore, India
Clinical Research Coordinator
GDD experts
Nagpur
09.2020 - 09.2021
- Company Overview: Nagpur, India
- Participate in site feasibility analysis, initiation visits, investigator’s meetings, monitoring visits, close- out visits and QA, Sponsor as well as Regulatory Audits for assigned clinical trials and implement these trials according to a deadline schedule mutually agreed upon by PI and sponsor
- Screened, counseled and followed-up with subject volunteers for Clinical Trials as well as BA/BE studies in accordance with protocol
- Collected Electrocardiogram required as per protocol
- Collected, prepared, reviewed, analyzed and filed essential trial documents
- Ensured accurate entry of site detain CRF & assist in query resolution
- Processed blood samples of subjects for Clinical Trials as well as PK Trials
- Directed the conduct of clinical studies to ensure adherence to the research protocol, ND CTA rule 2019 and ICH-GCP across therapeutic areas namely Orthopedic, Endocrinology, Gastrointestinal, Cardiovascular, Psychiatry as mentioned below
- Conducted screening, recruitment, counseling, and follow-up of study subjects
- Coordinated submissions to ethics committee of protocol, adverse events and periodic study reports for review and ensured that all documentation to and from ethics committee is appropriately maintained
- Collected, prepared, and updated essential trial documents related to IRB/EC documentation, laboratory, Investigational Product, safety reporting etc
- Prepared, updated, maintained, and archived Site Investigator File & Trial Master File
- Ensured accurate and complete data entry into case report forms& eCRF developed by Oracle, CRF Web, CLINION, BIZNET, INFORM
- Ensured timely resolution of data queries
- Advised & alerted investigators of potential protocol and regulatory violations
- Ensured audit readiness of site
- Nagpur, India
Clinical Research Coordinator
Quintessential Solutions LLP
Ahmedabad
12.2018 - 08.2020
- Company Overview: Ahmedabad, India
- Ahmedabad, India
Education
Master of science - Biochemistry
Rashtrasant Tukdoji Maharaj Nagpur University
Nagpur01.2018
Diploma in Clinical Research Management (DCRM) -
Alchemy Clinical Research Services
Nagpur01.2018
Bachelor of science - Biochemistry
Dr. Ambedkar college
Nagpur01.2016
Skills
- Convincing power
- Time Management
- Approachable
- Organized
- Efficient
- Leadership
- Communication skill
- Decision Making
- Conflict Resolution
- Proficient in Windows based Operating System
- Excellent Knowledge of ICH GCP
- NDCT rule 2019
- USFDA
- Audit Support
- Root Cause Analysis
Languages
- English
- Hindi
- Marathi
- Gujarati
Personal Information
Nationality: Indian
Accomplishments
- IQVIA Impact Award
Timeline
Global Site Activation Analyst
IQVIA
02.2024 - Current
Global Clinical Trial Assistant
IQVIA
11.2021 - 02.2024
Clinical Research Coordinator
GDD experts
09.2020 - 09.2021
Clinical Research Coordinator
Quintessential Solutions LLP
12.2018 - 08.2020
Master of science - Biochemistry
Rashtrasant Tukdoji Maharaj Nagpur University
Diploma in Clinical Research Management (DCRM) -
Alchemy Clinical Research Services
Bachelor of science - Biochemistry
Dr. Ambedkar college
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