Nilanjan Sen
Bangalore
Summary
Experienced Associate Global Site Activation Analyst with a demonstrated history of working in clinical research. Proven expertise in regulatory compliance, documentation and reporting, and site activation activities. Adept at performing quality control of documents, overseeing the preparation of site regulatory documents, and ensuring adherence to SOPs and project timelines. Skilled in risk mitigation, KPI analysis, and continuous improvement. Previous role as Clinical Research Coordinator involved patient assessments, data collection, and collaboration with stakeholders to ensure efficient trial execution. Proficient in MS Word, MS Excel, PowerPoint, CTMS, and TMF. Career goal includes advancing within the clinical research field while contributing to innovative healthcare solutions.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Associate Global Site Activation Analyst
IQVIA(RDS) INDIA PVT.LTD
Bangalore
05.2023 - Current
- 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 startup 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 the project team during initial and ongoing projects.
- May have direct contact with sponsors on specific initiatives.
Clinical Research Coordinator
CliniMed LifeSciences Pvt. Ltd.
Kolkata
12.2020 - 04.2023
- Performed patient assessments, collected and analyzed data, and prepared reports
- Prepared informed consent forms for review by ethics committees
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial
- Compiled trial related documents into a master file as required by sponsor or regulatory agency
- Reviewed CRFs for completeness and accuracy before database entry
- Developed case report forms for data collection at investigational sites
- Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results
- Assisted in the preparation of Institutional Review Board submissions for clinical trials
- Monitored patient safety during clinical trials according to established guidelines
- Developed and maintained accurate and timely study databases
- Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities
- Coordinated investigator meetings, conference calls, and site initiation visits as needed
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials
- Collected, processed and delivered specimens from trial participants
- Took vital signs and collected medical histories as part of study protocols
- Monitored subject enrollment and tracked dropout details
- Educated participants on studies and anticipated outcomes
- Conducted screening interviews to determine eligibility of possible subjects
- Placed orders for medications to be used in studies
Education
Post graduate diploma -
Jadavpur University
Kolkata09.2022
Master of Science - Microbiology
West Bengal State University
Kolkata07.2019
Bachelor of Science - Microbiology(H)
Calcutta University
Kolkata10.2017
Skills
- Clinical Research
- MS Office Suite
- Site ID
- Contract Negotiation Oversight
- Site Activation
- Site Maintenance
- KPI analysis
- Documentation And Reporting
- Site Feasibility
- Regulatory compliance
- Compliance Analysis
- Forecasting ability (UPT/QIP, EAC Tools)
- Team collaboration and leadership
- CTMS
- TMF (Wingspan, ELVIS, and Veeva Vault)
- Site Activation Workflow
- Site ID Workflow
- IQVIA Feasibility
- Regulatory Intelligence Database (RID)
Certification
- Good Clinical Practice (NIDA), 12/01/20, 12/01/23
- Certification course in Information Technology Applications (CITA), 01/01/19
- Certificate on Clinical Research & Regulatory Affairs, 2022
Hobbies and Interests
- Traveling
- Book Reading
- Cooking
- Cricket
Languages
- English
- Hindi
- Bengali
Timeline
Associate Global Site Activation Analyst
IQVIA(RDS) INDIA PVT.LTD
05.2023 - Current
Clinical Research Coordinator
CliniMed LifeSciences Pvt. Ltd.
12.2020 - 04.2023
Post graduate diploma -
Jadavpur University
Master of Science - Microbiology
West Bengal State University
Bachelor of Science - Microbiology(H)
Calcutta University
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