Hemalatha Lenin
Coimbatore
Summary
Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills
Overview
16
16
years of professional experience
1
1
Certification
Work History
TMF Lead
Parexel International
Hyderabad
04.2024 - Current
- Facilitated study kick-off meetings, driving discussions on TMF plan design.
- Provided recommendations on TMF budget and resource implications based on client expectations.
- Collaborated with Project Leader to establish realistic client expectations for TMF oversight.
- Coordinated TMF milestones alongside TMF reviewers, adhering to established timelines and quality criteria.
- Identified potential project risks related to TMF deliverables, proposing solutions to project teams and clients.
- Led internal monthly TMF review meetings, delivering regular status updates on TMF progress.
- Maintained proactive communication with clients, addressing concerns regarding TMF processes.
- Monitored TMF Inspection Readiness, escalating issues and suggesting actionable items when necessary.
TMF Reviewer
Parexel International
Hyderabad
01.2022 - 03.2024
- Collaborated with TMF Inspection Readiness Specialist to plan and execute tasks efficiently.
- Maintained oversight of planning, providing proactive status updates to study team and specialists.
- Sought responsible solutions to enhance client satisfaction and project outcomes.
- Delivered feedback to PS/FL super users in CRS technology to improve systems and processes.
- Conducted completeness checks and milestone reviews for TMF according to Parexel SOPs.
- Cooperated with LM and FLs on TMF tasks to ensure project alignment.
- Prepared for audits by implementing proactive measures and facilitating internal/external TMF audits.
- Managed customization of TMF tools and development of TMF plans for study compliance.
Record Management Specialist
Icon Clinical Research Private Ltd
Chennai
02.2021 - 12.2021
- Ensured consistent receipt and classification of essential and non-essential clinical trial documents.
- Indexed documents in eTMF Veeva Vault with required metadata for tracking.
- Performed peer reviews to verify final state of documents before submission.
- Communicated rejection information via Microsoft Forms and notified senders promptly.
- Generated inactivation and reclassification reports, completing tasks as necessary.
- Coordinated communications on study documentation progress among functional areas.
- Analyzed reports to enhance document processing efficiency.
- Maintained weekly metrics for document processing, errors, and delays using Excel.
Technical Document operation Specialist
Icon Clinical Research Private Ltd
Chennai
06.2016 - 08.2018
- Executed system administration for Phase II to V clinical trials, activating and closing study sites.
- Managed timely data entry into specific applications to ensure accuracy.
- Performed manual data entry in Trial Master Files (TMF) to enhance document integrity.
- Coordinated progress communications and completion updates on data entry activities.
- Utilized computer skills for mail merging documents, letters, and labels efficiently.
- Ran queries in Access to support data analysis needs.
- Conducted initial quality control of electronic documents to maintain compliance.
- Trained new joiners on processing clinical trial documents and related procedures.
Senior QC – Clinical Research Associate
Micro Therapeutic Research Labs
Chennai
05.2014 - 01.2016
- Managed clinical trials, ensuring timely completion and adherence to expectations.
- Developed standard operating procedures (SOPs) and documentation for clarity.
- Implemented recruitment strategies in accordance with protocol, GCP, and ICH guidelines.
- Performed quality control activities on clinical raw data and metadata.
- Reviewed protocols, study CRFs, informed consent forms, and regulatory documents.
- Coordinated with QA team to enhance overall document
Clinical Research Coordinator
PSG Institute of Medical Science
Coimbatore
08.2012 - 02.2014
- Facilitated CRF data transfer, query generation, and resolution processes.
- Verified compliance with approved protocols and amendments for participant involvement.
- Ensured informed consent forms were obtained prior to subject participation.
- Maintained accuracy and completeness of source documents and trial-related records.
- Monitored submission of required reports and applications from investigators for compliance.
- Prepared materials for investigator meetings to support effective communication.
- Managed dispensing and accountability of study drugs throughout trials.
- Coordinated processing and shipping of lab specimens to ensure timely analysis.
Clinical Research Associate
Micro Therapeutic Research Labs
Chennai
10.2010 - 04.2012
- Coordinated with clinical, bio-analytical, and quality assurance departments to ensure seamless workflow.
- Revised, corrected, and implemented SOPs in collaboration with quality assurance teams.
- Designed case report forms and informed consent documents while monitoring compliance with protocols and SOPs.
- Conducted pre-study and post-study meetings with the ethics committee to ensure alignment.
Clinical Research Associate
Consortium CRO
Coimbatore
10.2009 - 05.2010
- Executed site monitoring activities, including assessment, initiation, routine monitoring, and closeout tasks
- Executed site monitoring activities, including assessment, initiation, routine monitoring, and closeout
- Identified and selected investigators responsible for trial conduct at respective sites.
- Coordinated with doctors and consultants to facilitate trial execution.
- Established trial sites by ensuring availability of necessary materials, including investigational medicinal products.
- Trained study staff on clinical trial SOPs in compliance with regulatory requirements.
- Verified investigator team training and adherence to protocols while ensuring IRB/IEC compliance.
Education
PG Diploma - Clinical Research Management & regulatory affairs
Consortium CRO
Coimbatore, India12.2009
M.Sc. - Biochemistry
Avinashilingham University
Coimbatore, India01.2009
B.Sc. - Biochemistry
Sree Narayana Guru College
Coimbatore, India01.2007
Skills
- TMF management
- Clinical trial oversight
- Client communication
- Team collaboration
- Training development
- Problem resolution
- Multitasking
- Analytical thinking
- eTMF, Veeva Vault, PMED, and CTMS expertise
- CTMS and SharePoint familiarity
- Audit preparation
- Risk identification
Certification
- Astra Nova Certificate for completing training on 'ICH Topic E6 (R1) Guideline for Good Clinical Practice' by the European Medicines Agency
- Quintiles certificate for completing training on 'Introduction to the Clinical Drug Development Process: ICH Good Clinical Practice for Clinical Trial Sites'
- Certified twice in the ICH-GCP workshop conducted by Dr. Anupama Ram Kumar
- Protocol details, SAE reporting and timelines for reporting, pharmacovigilance, Schedule Y, ICH guidelines, and good clinical practice sessions
Languages
English and Tamil
References
References available upon request.
Timeline
TMF Lead
Parexel International
04.2024 - Current
TMF Reviewer
Parexel International
01.2022 - 03.2024
Record Management Specialist
Icon Clinical Research Private Ltd
02.2021 - 12.2021
Technical Document operation Specialist
Icon Clinical Research Private Ltd
06.2016 - 08.2018
Senior QC – Clinical Research Associate
Micro Therapeutic Research Labs
05.2014 - 01.2016
Clinical Research Coordinator
PSG Institute of Medical Science
08.2012 - 02.2014
Clinical Research Associate
Micro Therapeutic Research Labs
10.2010 - 04.2012
Clinical Research Associate
Consortium CRO
10.2009 - 05.2010
PG Diploma - Clinical Research Management & regulatory affairs
Consortium CRO
M.Sc. - Biochemistry
Avinashilingham University
B.Sc. - Biochemistry
Sree Narayana Guru College