Kankana Bhuyan
Golaghat
Summary
Motivated professional seeking a long-term career in the clinical research industry. Eager to contribute knowledge, experience, and skills to fulfill organizational requirements and personal goals. Committed to excellence, aiming to effectively utilize abilities and make valuable contributions to organizational success.
Overview
7
7
years of professional experience
Work History
Record Management Analyst 1
IQVIA
07.2018 - 08.2024
- Actively performing document Pre-QC, indexing to sponsor specific e-TMF Veeva vault, PhlexGlobal and performing QC on Sponsor eTMF and Wingspan Projects.
- As as Team Lead assigning day to day work to team members as per required FTE and monitor for completeness.
- Responsible for gathering data requested by the study team to support status reports to clients.
- Working on QIs i.e. discrepancies identified during the TMF review process
- Train team members on Project requirements ,updates Monitor filing accuracy and compliance to company and customer file plans and SOPs
- Performing complex processes and tasks that eventually result in high-quality deliverables completed according to service level agreements (SLAs) and within project timelines
- Monitor and assist in the preparation of closed studies for transfer to clients per agreed due dates
- Collaborates with QPM Project Leader and the other Functional Leads to confirm TMF activities are completed and accurate.
- Conducting TMF Completeness Check (Periodic Review) of the study, steering study- related Kick-off Meetings, managing expected documents list (EDL), helping the study teams correct filling of the documents, and archiving the reflections.
- Overview of TMF at all levels, like EDL Management, TMF Completeness Check Coordination (Periodic Review), Spot Check activity, and Study Management
- Collect data and assist in the preparation of reports for management on all phases of record management operations.
- Maintain accurate indices and databases to control inventory.
- Maintain an understanding of applicable regulatory requirements.
- Attend internal or external study team meetings as required and implement action items.
- Collaborate with the team members in the review of study documents.
- Participate in business improvement initiatives to drive quality, productivity, and continuous improvement of business
- Ensure overall client satisfaction for all studies
Research Executive
Ambrosia Life Sciences Pvt Ltd
02.2018 - 06.2018
- Conducting trial at two sites, CRC related roles, coordinating and monitoring multisite
Clinical Research Coordinator
Ambrosia Life Sciences Pvt Ltd
03.2017 - 01.2018
- Assisting Investigator in conducting trial at site.
- Patient screening and enrolment as per inclusion/exclusion criteria, follow up of patients.
- Responsible for informed consent process, ensuring participants understand the study's risks and benefits.
- Maintaining Source Document and CRF, Reporting to Project Lead .
- Adhere to good clinical practices and study protocols.
Education
Master in Business Management - Operation Management
Amity University (Amity Online)
Advanced Post Graduate Diploma - Clinical research, Clinical Data Management & SAS
Cliniminds
B.Tech - Biotechnology
Heritage Institute of Technology (MAKAUT)
Diploma Engineering -
Acharya Polytechnic
HSLC -
Barpathar Higher Secondary School
Skills
- Excellent knowledge of MS Office (Word, PowerPoint) and MS Excel
Experienced in Platforms such as Wingspan QC, Veeva Vault, PhlexEview ,CTMS, EEL-C, ELVIS, SharePoint, and Document Inventory List,ENF Reporting
Comprehensive knowledge of Essential documents (Trials Masters Files) of Clinical Research
General understanding of Clinical Data Management (CDM), Regulatory Affairs (RA), Adverse Events (AE), and Serious Adverse Events (SAE)
Comprehensive knowledge about ICH GCP Regulation regarding drug research
Knowledge about US FDA regulations and Indian Regulations
- Proficient in working in Windows OS
Languages
English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Assamese
Bilingual or Proficient (C2)
Bengali
Advanced (C1)
Home
+91-8777061885
Disclaimer
I hereby declare that the information given above is genuine to the best of my knowledge and you give an opportunity to work in your organization, I will put my best efforts.
Addresses
Barpathar College Road, Ward No-8, Dist-Golaghat, P.O.-Barpathar, Golaghat, Assam, 785602
Timeline
Record Management Analyst 1
IQVIA
07.2018 - 08.2024
Research Executive
Ambrosia Life Sciences Pvt Ltd
02.2018 - 06.2018
Clinical Research Coordinator
Ambrosia Life Sciences Pvt Ltd
03.2017 - 01.2018
Master in Business Management - Operation Management
Amity University (Amity Online)
Advanced Post Graduate Diploma - Clinical research, Clinical Data Management & SAS
Cliniminds
B.Tech - Biotechnology
Heritage Institute of Technology (MAKAUT)
Diploma Engineering -
Acharya Polytechnic
HSLC -
Barpathar Higher Secondary School
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