Clinical Research& Trials
Reporting & Documentation
Budgeting & Forecasting
Training & Development
Leadership & Team Management
Qualified Clinical Research Associate offering my 15+ years of experience in Clinical Research& Operations with expertise in Clinical trials, Pharmacokinetic and Statistical Analysis, Good clinical Practices (GCP), Good Laboratory Practices, Clinical Research Protocols, local and international regulatory requirements (conforming to USFDA, EMA, HPFB, TGA, ANVISA, CDSCO, and others).
Currently associated with Aizant Drug Research Solutions - Hyderabad as Clinical Manager; providing assistance to project teams& study managers for ongoing studies, administering clinical trials, maintaining proper documentation and ensuring compliance with company SOPs & guidelines.
Expertise in all aspects of the clinical trial start-up including, identification, evaluation and management of CROs and vendors. Developed and manage the budget, timeline, monitoring schedule and all monitoring activities.
Excellence in site selection, qualification, monitoring and ongoing site/investigator support. Wrote and maintained Monitoring, Data Management and Communication Plans.
Therapeutically knowledge in Infectious Disease (Travelers’Diarrhea), Oncology (Metastatic Breast Cancer - Phase II & III), Endocrinology (Diabetic Type I & II), Ophthalmology (Uveitis and Conjunctivitis) and Cardiovascular.
Monitored & ensured that the project progressed according to quality standards & SOPs to fulfill local regulations and was completed within budget, as per schedule and according to contract specifications.
Effective in conducting trainings for New Document Specialist and CRAs on sponsor applications.Detail-oriented professional with attention to details, accuracy, and teamwork.
Oct’18 – Present: Aizant Drug Research Solutions - Hyderabad as Manager Clinical trials
Key Result Areas:
Outsourcing and contracting services provided throughout Drug Development; Identifying, selecting and managing global external service providers
Maintaining the relationship with contract research organizations
Evaluating and analyzing tools and processes to support outsourcing efforts
Coordinating for contracts investigators for studies and ensures compliance with protocol and overall clinical objectives
Providing accurate and timely plans and forecasts for clinical trial cost estimates and budgets; ensuring efficient and compliant contracting of providers
Validating monthly expense accruals; and providing insightful analyses used to improve future planning
Collaborating with Legal, Finance and other internal stakeholders on continuous improvement of processes and methodology for contracting with all clinical vendors
Applying strategic sourcing methodology to assure attainment of best service and value and assuring vendor performance against agreed upon expectations
Interfacing with colleagues in R& D to ensure the team is using consistent and efficient business processes and tools for outsourcing and vendor management that are compliant with GCP, SOPs, and corporate financial controls
Managing vendor agreements, supporting the oversight of transferred obligations, and ensure that clinical trial budgets are based on current operational assumptions
Communicating with relevant Development Team members, and Functional Leaders ensuring appropriate providers are identified and managed efficiently
Executing tasks as requested by Senior Management to support Drug Development goals and project objectives
Monitoring, controlling, and reporting expenditures against established contracts and budget
Supervising administrative tasks for Advisory Boards & Institutional Business Meetings
Coordinating with Medical - as per applicable SOPs and guidance documents
Managing meeting expenses like honorariums, hotel, travel arrangements
As Clinical Trial Associate:
Worked as Reviewer & Approver of IIP (Investigator Initiation Package)
Mentored new & existing Document Specialist on SOPs & various applications, organized orientation programs for New Document Specialist & CRAs and provided trainings on sponsors applications
Acted as SME for Electronic Library & Records Archive (ELARA).
Assisted Project Manager/ Clinical Operations Lead and Lead CRA for all in-house project activities
Study Start-up Phase:
Assisted COLs in the preparation, timely and accurate review of ICFs for EC submission and approvals
Created & dispatched prefilling documents to all the sites participating in the trial
Followed up with Site Coordinator/Principal Investigator to ensure timely compilation of filing package (IIP)
Examined IIP documents, prepared site initiation kits & site master files and maintained compliance with ICH-GCP and SOPs to ensure consistence between Trial Master File and Site Master File
Resolved study related issues and facilitated communication between site personnel & clinical trial vendors including central labs & monitoring CROs
Maintained tracking spreadsheets and prepared sites for site audits conducted by Global Teams
Nov’17 - Sep’18: ZenRise Clinical Research Limited, Hyderabad as Manager Clinical trials
Executed and completed site initiation and training activities for site personnel
Analyzed study budget, generation of accurate TCF for line management approval
Ensured the preparation of required regulatory submissions & clinical sites IRB submissions and collect of necessary documents from site at trial startup and throughout conduct the study
Scheduled and updated the track for site drug supply and other trial related materials
Monitored and resolved the problems in site activities in line startup of clinical trials, patient recruitment and site closeout
Formulated appropriate contingency plans as needed
Completed and uploaded study monitoring reports in timely manner
Provided data query resolution at site activities and with Data management
Resolved site level of update problems in technical systems (EDC)
Acted as a CRA lead and ensure assigned site visit reports completions
Adhered to all continual GCP, ICH and internal SOP compliance (Informed consent process, Source data verification, AE and SAE reporting, protocol, drug accountability )
Facilitated proper communication between site and organization line functions to increase the interest to investigator.
Participated in site selection conduct Feasibility Studies
Reviewed clinical study protocols & Informed Consent Forms, Case Report Forms and Coordinate EC submissions
Executed process audits at Study Sites as per SOPs, protocol & regulatory requirements
Sent follow up letters to sites and submit Visit Reports to the Project Manager as required
Monitored study deliverables, and contribute to the preparation of consent forms, study guides, monitoring plans, CRFs, and subject information sheets
Participated in study planning and set-up activities including vendor management and support, project management, and coordination of study and implementation plans
Distributed feasibility questionnaires to investigators being considered for study participation, track and summarize results
Initiated and tracked confidentiality agreements with sites and initiate and maintain investigator and site contact information
Worked with site teams to ensure that necessary corrections are made to expedite the document collection process and tracks status of documents to reflect receipt and approval
Updated Team Lead of site status and approval status so that drug can be shipped. Partners with site monitor for scheduling of study initiation visit
Organized training and maintain good working relationships with the site investigational staff
Sep’15 – Nov’17: ClinSync Clinical Research Pvt. Ltd. – Hyderabad as Asst. Manager – Clinical Pharmacology
Performed Site Qualification Visit/Pre Site Initiation Visit to identifying the potentiality of a site to match the protocol requirements for the proper conduct of the trial with quality data in timelines
Conducted Interim Monitoring Visit of Phase I, II & III clinical trials/clinical studies
Contributed in Investigational Product management like IP availability and tracking for various sites, timely shipment of IP at controlled temperature
Coordinated with required Regulatory authority and Ethics Committee dossier preparation and submissions of the clinical trials/clinical studies
To ensure stepwise management of recruitment target at each site and monitoring the delivery of recruitment targets against the recruitment plan
To ensure the preparation and maintenance of Clinical Trial Master File/ Project Master File and Site Master File
Preparation of Investigator’s Brochure, Case Report Form and Subject Diary Cards, under the supervision of Medical monitor/ Manager
Assist the medical monitor in writing of Protocol and ICD
Compiling and writing Clinical Study Report
Prepare accurate and timely monitoring reports
Coordination with data management department in handling of queries which may arise during data review process, validation, verification & analyses
Preparation of Informed Consent Document, Case Report Form, Subject Diary Cards, as per Trial Protocol & available information/data
Coordination with vendors for various pre-trial activities i.e. translations & back translations of the ICDs, diary cards; printing of all documents, procuring of CT supplies and ensuring the availability of all at clinical trial sites before the initiation of the study
Preparation of Prescribing Information/Package Insert (P.I), Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC)
Involved in literature search for various inputs to the department
Participate in preparation and review of departmental SOPs
Handled in-house audits for the clinical studies
Nov’13 – Sep’15: Fortis Clinical Research Pvt. Ltd. – Delhi as Senior Research Officer II
To organize induction and periodic training in quality systems (GCP/GLP) to the staff to facilitate study logistics and enhance manpower effectiveness.
To maintain an up to date knowledge of the regulatory environment and all national and international guidelines for clinical research and GMP/GCP/GLP.
To ensure that the QA dept is trained to perform their responsibilities and also ensure refresher trainings.
To analyze QA data and present compliance trends at the Management Review meeting to seek addressed of deviations.
To assist Head – Quality Management & training in creating an effective QA system to progressively enhance the quality of projects conducted at FCRL by close supervision & providing guidance to all QA personnel.
To plan and conduct internal quality audits as sought by management and provide management with clear visibility on the level of company’s compliance with required quality system during management review meetings.
To facilitate external audits by sponsors and regulatory bodies on behalf of Head-Quality management & training. Ensure timely and appropriate responses are sent towards external audits observations. Ensure that any CAPAs proposed as a result of external audits are tracked for timely and effective implementation.
To perform vendor audits at periodic intervals for qualification of vendors to be used for outsourcing certain specific activities.
Preparation, review and distribution of Quality Manual & Standard Operating procedures. Identify and ensure that all quality reference documents are kept up to date.
To participate in the safety committee meeting and disaster management plan of the organization on behalf of Head-Quality management & training.
Maintain the accreditations and certifications of organization.
Represent QA at operational and cross functional meetings whenever required.
To monitor the review of IQ/OQ/PQ reports of all computer systems and instruments.
Review of documents associated with validation of new systems and audit of ongoing maintenance and validation status of the system.
To conduct and monitor effectively the conduct of process audits, in-life & retrospective raw data and report audits for clinical and analytical.
Ensure quality outcomes and ensure no major/critical errors.
Ensuring that studies conducted are compliant with SOP, Protocol and applicable regulatory guidelines in real time manner to avert anyone compliance during process.
To conduct online checks during study to ensure increased surveillance of study at all times.
To initiate review and preparation of the standard operating procedures for various processes related activities and other involved processes on periodic basis.
To prepare the facility for external audits and actively involved infacilition of external audits and inspections.
To be involved in the review of required clinical/analytical/IT/Instrumentation/general and other departmental activities related SOPs on regular basis and provide comments on the same.
Maintain and update master file of the CRO and keep all updated agreements with vendors current.
Review periodically, the calibration records/certificates, preventive maintenance of the equipment.
Qualify the external agencies used for all studies conducted by FCRL in order to verify that vendor has adequate resources in place to execute activities in time and results are in consistent conformance to quality standards, regulatory and organizational requirements.
To plan conduct quality checks as sought by management and provide management with the clear visibility on the level of company’s compliance with required quality systems during management review meetings.
Verification of journal vouchers with supporting documents.
Verify of capex requests/approval notes.
Physical verification of stock items at regular intervals.
Jan’08 – Nov’13: Senior Research Associate GVK Biosciences Pvt. Ltd. – Hyderabad
To prepare monthly outputs of the team of projects completed and initiated to help tracking the cost of materials and supplies and provide the data to account section.
To monitor and guide the activities of reports group of the section.
To plan the project activities.
To define and monitor role and responsibilities of analysts for routine work, SOP, protocol and regulatory related compliance.
Sep’04 – Jan’08: Research Associate-III Aurobindo Pharmaceutical Ltd.
Initiate the requisition for Forms as per SOPs.
All logbooks and all forms documentation done as per SOPs and GCP, Fallow the GCP.
Reviewed validation and study reports; prepared SOP’s for instruments and methods while accomplish the groundwork for audit preparation.
MS Office Programs
Publications & Presentations:
Given a presentation on “Application of Computers in the Field of Pharmacy” in the conference of 55th Indian Pharmaceutical Congress held at Chennai
Certificate from WATERS GLOBAL SERVICES on Liquid Chromatography Mass Spectrometry
Certificate from SIX SIGMA BIOSOLUTIONS PVT. LTD. on International conference on Harmonization- Good Clinical Practice
Attended 53rd Indian pharmaceutical congress, Delhi
Attended 55th Indian pharmaceutical congress, Chennai
Attended 57th Indian Pharmaceutical congress, Hyderabad
Participated in the organization of recipe-2006(A National Pharmacy Meet)
B. Pharma. from SSR College of Pharmacy – Osmania University in 2005.
Date of Birth: 20th July 1982 Languages Known: English Passport Details: No. R6891902, valid till 2028
Address: H.No. 3-3-47/1, Baghameer Colony, Near Hanuman Temple, Kukatpally, Hyderabad, Telangana, India 500072
Phone No:+91-996*******, Email address: firstname.lastname@example.org.
CLINICAL RESEARCH & TRIALS
Phone: +91-996******* E-mail: email@example.com
Fortis Clinical Research Pvt. Ltd. – Delhi as Senior Research Officer II
Sep’15 – Nov’17
ZenRise Clinical Research Limited, Hyderabad as Manager Clinical trials
Aizant Drug Research Solutions - Hyderabad as Manager Clinical trials
ClinSync Clinical Research Pvt. Ltd. – Hyderabad as Asst. Manager – Clinical Pharmacology