Neena Samuel
TMF Specialist
Bengaluru
Summary
Meticulous and methodical document management professional 5.4-year background clinical research environments. Coordinates files and maintains workflows in compliance with business, customer and project management needs.
Overview
5
5
years of professional experience
1
1
Certification
Work History
TMF Document Specialist
IQVIA
Bangalore
06.2022 - Current
- Ensure all work is conducted in accordance with SOPs, policies (as agreed), Good Clinical Practices and applicable regulatory requirements
- Ensure project deadlines, commitments, and goals are met with Quality
- Serve as liaison between Records Management and Internal user departments regarding Trial Master Files
- Monitor and assist in preparation of closed studies for transfer to clients per agreed due dates
- Apply Records Management expertise to provide project related assistance across and multiple project(s), and project teams
- All procedures associated with Physical Storage and shipment of documents to Sponsor/RM Hubs in accordance with study instructions and within required timelines to be followed
- May serve as primary contact External clients
- May train team members on records management tasks, policies, and procedures
- May Function as team leader for records management projects
- May lead teams functionally, where assigned, including awareness of scope of work, budget, and resources
- May manage team of records management or technically related staff working in support of projects within designated office, Country or region.
Clinical Research Coordinator
Leads Clinical Research and Bioservices
Bangalore
10.2020 - 05.2022
- Handled and executed clinical trials in site level
- Involved in data capturing (source document EDC s)
- Ethics committee communication
- Involved in SAE and AE reporting
- Ensured all works are done according to study protocol, sop's and Good clinical practices.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Maintained compliance with protocols covering patient care and clinical trial operations.
Clinical Research Coordinator
Shichagi Medical Solutoions
Mysore
05.2019 - 08.2020
- Handled and executed clinical trials in a site level
- Involved in data capturing (source document EDC s)
- Ethics committee communication
- Involved in SAE and AE reporting
- Ensured all works are done according to study protocol, sop's and Good clinical practices.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
Education
Master of Science - Biochemistry
University of Mysore
undefined
Calicut university
Skills
Multitasking efficiency
Teamwork orientation
File Management
Veeva Vault
Recordkeeping skills
Project Support
Quality Management
Standard Operating Procedures
Records Management
Electronic Records Management
Good Clinical Practices
Certification
Good Clinical practice certification, 2022
Department specific experience
Records Management, VeevaVault, 1-3, Indexing, 1-3
QC-1-3
Languages
English
Malayalam
Kannada
Timeline
TMF Document Specialist
IQVIA
06.2022 - Current
Clinical Research Coordinator
Leads Clinical Research and Bioservices
10.2020 - 05.2022
Clinical Research Coordinator
Shichagi Medical Solutoions
05.2019 - 08.2020
Master of Science - Biochemistry
University of Mysore
undefined
Calicut university
Similar Profiles
Megan MunroeMegan Munroe
Associate Scientist at IQVIAAssociate Scientist at IQVIA
Asmat ShaikhAsmat Shaikh
Associate Director, Safety Project Leadership at IQVIAAssociate Director, Safety Project Leadership at IQVIA
Lokesh ALokesh A
Salesforce Engineer-2 at IQVIASalesforce Engineer-2 at IQVIA