Suma B K

To utilize skills and knowledge to add value to the organization and establish a career in pharmaceutical work and research.

Over 6.5 years of experience in Clinical Research, specializing in study administration and data management. Strong understanding of GCP compliance, protocol management, and training of study personnel.

• ICH-GCP training, Lotus Labs Pvt. Ltd., Bangalore, Karnataka
• Pursuing the course of Clinical Research and Clinical Data Management, BCRI, Bangalore, 02/01/25

• SOP training completion and status reporting.
• SOP coordination and change control management.

• Attention to Detail, Reviewing and Ensuring Accuracy of Study Documents, Cross-Checking Data with Source Documents
• Problem-Solving, Resolving Queries Efficiently, Addressing Issues Raised by Sponsors and Investigators
• Teamwork and Collaboration, Working Effectively with Diverse Teams, Supporting Team Members and Facilitating Communication
• Adaptability, Flexibility in Handling Various Tasks and Responsibilities, Adapting to New Technologies and Processes

• Date of Birth: 05/05/94
• Nationality: Indian

• Reviewing protocols and informed consent documents.
• Preparing study documents and monitoring study activities.
• Coordinating with various departments (protocol team, PMG, medical writing team, stats team, CDISC team).
• Designing paper CRF and eCRF, preparing SDTM templates, and entering data.
• Maintain and manage the Trial Master File (TMF) for clinical trials to ensure compliance with regulatory requirements.
• Coordinate the collection, review, and filing of essential documents from clinical sites, sponsors, and other stakeholders.
• Perform quality checks on TMF documents to ensure accuracy, completeness, and compliance.
• Assist in the development and implementation of TMF processes and standard operating procedures (SOPs).
• Managed the electronic Trial Master File (eTMF) utilizing the TGEC platform within Veeva Vault.
• Uploaded, organized, and conducted quality reviews of eTMF documents to ensure compliance with regulatory standards.
• Collaborated with cross-functional teams to maintain high document quality and readiness for inspections.
• Supported clinical trial operations by managing documentation from initiation to closeout phases.
• Handling monitors during studies and close-out visits.
• Coordinating with USFDA and other regulatory auditors.
• Ensuring compliance with FDA, ICH, and GCP regulations.
• Providing study status updates and resolving site issues.
• Review of case report forms.
• Designing of paper CRF and eCRF, data validation systems, and standard operating procedures.
• Performing UAT, data management activities, and SAE reconciliation.
• Generating metric reports and managing study activities.

• Presented a poster on cardiotoxicity, 68th IPC, Visakhapatnam, Andhra Pradesh, 12/01/16
• Attended seminars on drug discovery and current status and future perspectives in pharmaceutical sciences.
• 150 hours, Bangalore, Karnataka, Embiotic Laboratories, QC, tablet, capsule, liquid oral, ointment, creams