Anshu Jul
Warangal,Telangana
Summary
Accomplished professional with expertise in clinical trial management, regulatory compliance, and quality assurance. Demonstrates proficiency in risk-based monitoring, vendor management, and cross-functional collaboration to ensure seamless project execution. Skilled in leveraging advanced systems such as EDC, CTMS, e-TMF, and IRT to optimise data management and analysis. Adept at budget management and risk assessment, with a proven track record of driving operational excellence while maintaining strict adherence to regulatory standards. Committed to fostering leadership and team development to achieve organisational goals.
Overview
3
3
years of professional experience
1
1
Certification
Work history
Global Clinical Trial Manager
XXXXX
- Designed and delivered comprehensive training programs for CRAs and CTAs, enhancing proficiency in study protocols, regulatory requirements, and best practices, leading to improved team performance and compliance
- Ensured regulatory compliance across regions and supported inspections and audits, overseeing the preparation and submission of regulatory/ethics documents, Technical Assurances, and CPMS portal management
- Fostered effective communication and robust relationships among team members, clients, and vendors to enhance service delivery and maintain high standards of trial support
- Led CRA teams across Europe in planning and executing Phase I-III trials, providing mentorship through co-monitoring visits and coordinating operations to manage site performance, ensure quality, and achieve enrolment targets throughout the clinical trial process
- Managed issues, risks, and scope changes, ensuring timely escalation of trends and out-of-scope requests to maintain project alignment
- Managed start-up activities, ensuring smooth project initiation and supporting SSU teams with regulatory/ethics submissions, Technical Assurances, ARSAC and CPMS portal management and associated documentation
- Reviewed site visit reports, addressing issues within defined timelines and ensuring all necessary documentation was accurately maintained
Senior CRA/ CTM (Hybrid Role)
XXXXXX
Senior Clinical Research Associate
XXXXXX
Senior Clinical Research Associate
XXXXX
Clinical Research Associate
INC Research
Formulation Scientist
Bristol Laboratories
Freelance Clinical Operations Expert
XXXXXX
01.2022 - 01.2025
- Support audit and inspection readiness and address findings effectively
- Manage clinical trial budgets at both global and regional levels, covering subject costs, investigator payments, vendor expenses, and cost projections
- Ensure efficient use of financial resources by performing variance analyses and communicating projected cost overruns or underspending to the finance team
- Develop and maintain key project documents like ICFs, Study Plans, and Training Materials
- Collaborate with cross-functional teams, including sponsors, vendors, and functional leaders of internal departments, to achieve project milestones, support PMs and CTMs, coordinate Regulatory and Ethics Committee submissions across participating countries, and provide feedback on functional plans to ensure smooth delivery handoffs and meet study milestones
- Manage and oversee multiple global and regional clinical trials from study start-up to closeout, ensuring adherence to timelines, budgets, and quality standards
- Monitor and report on key performance indicators (KPIs), including time, cost, and quality metrics, to ensure project success
- Design and support patient-centric and site-centric recruitment and retention strategies in consultation with sponsors, study leads, and relevant stakeholders, such as local NIHR Clinical Research Network portfolio and Patient Advocacy Groups to boost recruitment
- Ensure all trials are conducted in compliance with ICH-GCP, SOPs, and applicable regulatory requirements (MHRA, EMA, FDA, Ethics Committee)
- Manage and oversee the preparation and submission of regulatory documents to regulatory bodies, ethics committees, HRA, and local R&Ds
- Develop and implement risk management strategies by proactively identifying potential risks early in the project lifecycle and establishing mitigation plans using the Risk Assessment and Categorization Tool (RACT)
- Manage site operations, including clinical and central monitoring, to ensure patient safety, compliance with protocol/GCP, and data integrity and oversee IMP and trial supply management
- Design and deliver comprehensive training for the study team on protocol, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans, guidelines, data plans, and study timelines
- Organise routine CRA and CTA team calls for knowledge sharing and promoting best practices
- Participate in candidate evaluations and training to ensure smooth team integration
- Ensure the eTMF is complete and up to date, maintaining it 'Inspection Ready' at all times
- Manage vendor partnerships from selection to daily operations, ensuring compliance with timelines and fostering reliable relationships
- Reviews the quality and content of the site and central monitoring documentation (e.g., site visit reports, monitoring calls, site letters, and central monitoring reports) to ensure they accurately reflect site management activities and identify risks to protocol compliance, GCP, trial conduct, patient safety, or data integrity
Pharmacy Technician
Alliance Boots Pharmacy
- 02.2013
Education
Masters -
Pharmaceutical Sciences
Bachelors - Pharmacy
Kakatiya University
Skills
- Audit & Inspection Readiness
- Budget Management
- Clinical Trial Management
- Cross-Functional Collaboration
- EDC
- CTMS
- E-TMF
- IRT
- Vendor systems
- Data Management & Analysis
- Leadership & Team Management
- Microsoft Office Suite
- Project Management
- Quality Assurance
- Regulatory Compliance
- Risk-Based Monitoring
- Risk Assessment and Management
- Vendor Management
Certification
- Certified Project Management Professional (PMI)
- Good Clinical Practice (GCP) Certification
- Member of the Research Quality Association (MRQA)
- GCP Inspection/Audit – Principles and Practice Certification (MRQA)
Languages
Fluent in English
Hindi
Telugu
Custom
- Senior CRA/ CTM (Hybrid Role), XXXXXX
- Senior Clinical Research Associate, XXXXXXX
- Senior Clinical Research Associate, XXXXX, 07/01/20XX, 05/01/20XX
- Clinical Research Associate, INC Research, 10/01/20XX, 07/01/20XX
- Formulation Scientist, Bristol Laboratories, 03/01/20XX, 07/01/20XX
- Pharmacy Technician, Alliance Boots Pharmacy, 12/01/20XX, 02/01/13
Timeline
Freelance Clinical Operations Expert
XXXXXX
01.2022 - 01.2025
Global Clinical Trial Manager
XXXXX
Senior CRA/ CTM (Hybrid Role)
XXXXXX
Senior Clinical Research Associate
XXXXXX
Senior Clinical Research Associate
XXXXX
Clinical Research Associate
INC Research
Formulation Scientist
Bristol Laboratories
Pharmacy Technician
Alliance Boots Pharmacy
- 02.2013
Bachelors - Pharmacy
Kakatiya University
Masters -
Pharmaceutical Sciences
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