Chitransh Mahajan
Clinical Study Associate
Kalyan
Summary
Dynamic Clinical Study Associate at TCS with expertise in managing clinical studies and optimizing TMF processes. Proven ability to enhance team productivity through effective communication and project management. Skilled in data analysis and reporting, fostering strong client relationships, and training new team members to ensure compliance and quality in regulatory documentation.
Overview
1
1
year of professional experience
1
1
Certification
3
3
Languages
Work History
Clinical Study Associate
TCS
09.2024 - Current
- Responsible for collecting, reviewing, maintaining, and archiving essential regulatory documents for TMF in accordance with GCP, other regulatory guidance documents, relevant regulations, and SOPs.
- Processing the documents as per the TMF index, and planning for the respective studies.
- Providing support for the TMF content owners on one or more clinical programs.
- Working closely with the study management teams to ensure that the Veeva Vault is kept both current and inspection-ready according to SOPs.
- Working with eTMF content owners to identify issues, perform complete checks, and upload documents to Veeva Vault.
- Following up on the quality findings, and responding to the content owners.
- Track and report metrics as determined by management, according to the timelines.
- Complete day-to-day tasks, ensuring quality and productivity, and assist the team lead in work assignments and compliance checks.
- Completing the required training within the timeline.
- To train the new joiner on the team.
- Obtain and collate feasibility information from sites, and track it in Compass.
- Develop and QC site-specific regulatory document templates, and customize them with site information.
- QC essential documents were received from sites and managed Corrections with sites, and upload to TMF.
- Localization of ICFs.
- Study site facing portal (Drug Dev/Longboat) setup and document upload, maintenance, and archiving.
- Perform study, country, and site-level updates based on role-specific requirements.
- Perform a debarment check of the principal or sub-investigator as per FDA 1572 forms.
- Perform study and site-level filing based on role-specific requirements.
- Conduct and Closeout Phase - RASCI
- Study Team Roster Management in CTMS.
- Maintain and manage study site staff information in CTMS.
- CTMS milestone updates (study and site document filing in TMF).
- Monthly escalation of overdue quality, oversight issues, and completeness reviews.
- Oversight of TMF completeness reviews.
- Regular follow-up with document owners regarding aging, In Progress, and QC Rejected documents.
- Site-level TMF, Central-level, Country-level - filing/reconciliation - Documents owned by Study Management, Clinical Monitoring.
- Increased customer satisfaction by resolving complex issues and providing exceptional service at all times.
- Established strong relationships with key stakeholders, facilitating effective communication across departments and teams.
- Enhanced team productivity by streamlining communication and implementing efficient project management tools.
- Optimized departmental processes with the implementation of innovative strategies, resulting in improved efficiency and reduced costs.
- Developed and implemented strategies to increase customer satisfaction and engagement.
- Played an integral role in launching successful projects by coordinating tasks among team members while adhering closely to established timelines and budgets.
Education
Bachelor of Pharmacy - Pharmaceutical Sciences
Saraswathi Vidya Bhavans College Of Pharmacy
Mumbai, India 04.2001 -
Skills
Experienced with MS Office applications
Certification
Nptl course for current regulatory requirements for conducting clinical trials in India
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
swipe to browse
Timeline
Clinical Study Associate
TCS
09.2024 - Current
Nptl course for current regulatory requirements for conducting clinical trials in India
07-2023
Bachelor of Pharmacy - Pharmaceutical Sciences
Saraswathi Vidya Bhavans College Of Pharmacy
04.2001 -