Shubhendu Singh

Clinical Study Support & Monitoring – Assisted in daily clinical study oversight, responding to investigator, site, CRA, and client inquiries per GCP and SOPs.

Quality

Control & Protocol Compliance – Conducted QC for subject visits, requisition forms, and protocol updates, ensuring accuracy and adherence to study requirements.

Query

Management & Issue Resolution – Investigated and resolved subject visit issues by managing outgoing/incoming queries and coordinating with stakeholders.

SITE SERVICE SPECIALIST - ICON PLC - Bangalore

(2021-05)

• Clinical Study Support & Monitoring – Assisted in daily clinical study oversight, responding to investigator, site, CRA, and client inquiries per GCP and SOPs.
• Quality Control & Protocol Compliance – Conducted QC for subject visits, requisition forms, and protocol updates, ensuring accuracy and adherence to study requirements.
• Query Management & Issue Resolution – Investigated and resolved subject visit issues by managing outgoing/incoming queries and coordinating with stakeholders.
• Sponsor & Investigator Communication – Notified sponsors, investigators, and CRAs of critical protocol values and study related updates.
• Training & Team Support – Assisted in training new project team members and provided technical support for investigator sites, CRAs, and sponsors.
• Process Optimization & Complaint Handling – Reviewed site and sponsor complaints, implemented preventive measures, and supported app launch pilot trials. Database & Logistics Management – Maintained study databases, updated investigator/CRA details, managed site supplies, and coordinated with transitional vendors.

MEDICAL INFORMATION ASSOCIATE - EVERSENA - Pune

(2020-10 - 2021-04)

• Case Management & FDA Reporting – Entered ADR, AE, and SAE case files, ensuring accurate and timely FDA submissions.
• Call Handling & Issue Resolution – Assisted pharmacists, physicians, and consumers by addressing queries and resolving concerns.
• Mail Transcription & Documentation – Transcribed and recorded email communications related to case files and regulatory updates.
• Regulatory Compliance & Coordination – Ensured adherence to pharmacovigilance guidelines while coordinating with healthcare professional

RESEARCH ASSOCIATE SOURCE DOCUMENT VERIFICATION - HEALTH MINDS - Bangalore

(2019-10 - 2020-09)

Medical Research & Documentation

• Source Document Verification – Reviewed and validated clinical documents to ensure accuracy and protocol compliance.
• Physician Collaboration – Engaged with physicians to discuss and support their research paper publications.
• Data Interpretation – Assisted physicians in analyzing and interpreting research data for publication.
• Meetings & Coordination – Organized discussions with physicians to align research findings and publication goals.
• Reporting & Submission – Compiled and submitted research reports to relevant authorities and journals.

Master of Science - Biotechnology - R.K.D.F, BHOPAL (2018)

Bachelor of Science - Biotechnology - R.K.D.F, BHOPAL (2016)