Bhitali Lahkar
Thane
Summary
An accomplished Clinical Research Professional with successful track record of 5 years, in executing clinical research projects. Fundamentally strong in technical issues with proven strength in handling intricate situations with professional maturity. Energetic & team spirited individual with strong work ethics, problem-solving mindsets, proactive attitude, capable of thinking & generating new solutions & Ideas. Looking for a responsible position in clinical research, data management field with a view to grow as an individual along with the growth of the organization. Also having keen attention to detail for analyzing production and quality issues and compiling details reports for managers. Experience in performing regular equipment maintenance and upgrades to ensure product quality and supply.
Overview
5
5
years of professional experience
Work History
Senior ETMF Document Specialist
Tata Consultancy Services Ltd
Mumbai
06.2022 - Current
- Collaborating with the eTMF Team Lead, to ensure Trial Master File (TMF) business needs are addressed in a proactive and timely manner.
- Acting as a document creator / QC'er / primary contact for all issues related to TMF processing and inspection readiness.
- Checking Codependency,cross check and missing documents.
- Providing inputs to the management of the TMF processes as it relates to the Document Specialist interfaces.
- Uploading eTMF documents provided by CRO or sponsors.
- Completing and maintain the completed QC tracker on share drive and share the report with supervisor.
- Sharing QC feedback with associate for corrective and preventive action.
- Collaborating with the eTMF Team Lead to ensure alignment of processes across all Roche Functions.
- Delivering quality control measures and communication of relevant Roche TMF issues / challenges to the Senior.
- Providing input into functional SOPs, guidelines, and system user guides as related to the accuracy and completeness of TMF.
- Ensuring document quality requirements are agreed to & met by the study team, according to Completeness, Timeliness & Quality metrics.
- Developing and implement key quality & compliance goals & objectives.
- Performing discrepancy management in accordance with the process guidelines and timelines.
- Providing support during internal and external inspections by regulatory bodies.
- Performing in-depth process reviews, analyses and evaluations to aid continual evolution and growth.
- Compiling process reports to analyze and drive improvements across operations.
- Achieving targets by handling queries promptly and sharing comprehensive product knowledge.
Clinical Project Coordinator
Labcorp Drug Development
Bangalore
05.2019 - 06.2022
- Maintained Global Communication and Coordination with Covance Central Lab Services for region USA and GVA.
- Assisted with raising Sample shipment requests to sample handling, departments to route to referral labs or back to sites.
- Documented all service failures, resolve, and escalate to management when appropriate resolution is incomplete
- Provided Administrative and Tech Support to Central Lab Services.
- Provided support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues.
- Responsible for effective and timely adherence to management communications, meetings, and procedures.
- Provided Dedicated Support to Project Leads and functional leads (Sponsors).
Education
Post Graduate - Clinical Research
Avigna Clinical Research Institute (ACRI)
Bangalore01-2019
Bachelor of Science - Biotechnology
Guwahati University
Guwahati01-2018
Skills
- Excellent written and verbal communication skills
- Therapeutic area-Clinical Research experience
- Best knowledge of Good clinical practices
- Trial Management (Etmf Proficient, CTMS, EDC, DTMS)
- Study Protocols
- Goal development
- Reporting and Documentation
- Flexible and able to adapt quickly on new environment
- Proven interpersonal, organizational skills and analytical thinking
- Self-motivated
- GDPR compliance
- Project Management
- Scientific risk management
Professional Courses:
- Business Computer Application in 2015.
Technical Skills:
Understanding on drug discovery and clinical trial process., Knowledge of ICF and monitoring procedures involved in clinical trial., Knowledge on ICH/GCP principles, Schedule-Y, GLP/GMP guidelines., Understanding of BA-BE studies., Understanding of IRB/IEC., Understanding of regulatory requirements., Understanding of Clinical data management., Understanding of Clinical data management., SAE management.
Tools Knowledge:
MS word, MS excel, Zavacore, Work front, Track wise, Lab link, Xip, reflection etc. Etmf, RRM
Hobbies:
Reading books, travelling, cooking, listening to music.
Internship:
DNA Isolation and Extraction from Bone, Blood, Teeth and Blood Stain, Directorate of Forensic Science, Assam, 02/2018 - 07/2018, Training completion certificate.
Languages:
English
First Language
English
Upper Intermediate (B2)
B2
Hindi
Upper Intermediate (B2)
B2
Disclaimer:
I hereby declare that the above written particulars are true to the best of my knowledge, and I shall be obliged if you provide me the chance to work with you.
Timeline
Senior ETMF Document Specialist
Tata Consultancy Services Ltd
06.2022 - Current
Clinical Project Coordinator
Labcorp Drug Development
05.2019 - 06.2022
Post Graduate - Clinical Research
Avigna Clinical Research Institute (ACRI)
Bachelor of Science - Biotechnology
Guwahati University
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