Sponsor Clinical Research
Resume:
Address: **-******* ******* *********,
Opp. New High Court
S. G. Highway
Ghatlodia, Ahmedabad-380061
Mobile No.: +91-982*******
Email: *****************@*****.***
PERSONAL OBJECTIVE: As a clinical researcher inspired with the values of integrity and sincerity, I hope to make significant contributions to the field of clinical research through dedication and commitment.
Clinical professional with more than 19 years of experience possessing a strong emphasis in clinical research field and Pharmaceuticals (production).
Professional Experience
Date
Organization
Study
9 August 2021 to till date
Veeda Clinical Research
Responsible for supervision of protocol writing group
Feb 2021 – 6 Aug 2021
Accutest Research Laboratories (I) Pvt. Ltd.,
Designing of Protocols, Informed Consent Forms, Case record forms and other protocol related documents.
September 2020 – Jan 2021
ReClin Pharma Services (RPS)
Clinical services, Monitoring BA/BE trails, Regulatory affairs and impurity supply
(May 2003 – September 2020
Lambda clinical research ltd, Ahmedabad
Phase I, Drug –drug interaction, BA/ BE Trials
2 years
(2001- 2003)
Lincoln Pharmaceuticals
Production
(Tablet, Capsule, Liquid, dry Powder and Ointment)
Veeda Clinical Research
Department: BPD
Role: Deputy Clinical Manager (Duration: 9 August to till date):
Roles & Responsibilities:
Responsible for supervision of protocol writing group for all routine activities.
To ensure all protocols and related documents flow through various stakeholders and meet the committed timelines.
To supervise and ensure the ethics committee approval for all documents related to clinical studies and process involved therein.
To ensure finalization of protocols in coordination with internal department and sponsor as per required regulatory guideline, Sponsor Specifications and in compliance with the in-house standard practices.
Coordination with the sponsor, Project Management Team and other stake holders to address the bottlenecks.
Mentoring the new joiners through Trainings, lectures, seminars and practical hand holdings.
Handling of regulatory/sponsor queries.
Accutest Research Laboratories (I) Pvt. Ltd.,
Senior Research Coordinator (Duration: February 2021 to 06 August 2021):
Roles & Responsibilities:
Designing of Protocols, Informed Consent Forms, Case record forms and other protocol related.
Preparation and implementation of SOPs at the site with team members.
Planning, Preparation & Submission of dossier to IEC/IRB for approval.
Preparation of dossier of clinical documents for regulatory submission (i.e. BE/CT NOC, Import License applications etc.).
Handling of regulatory/sponsor queries.
Having enough awareness to various regulatory guidelines i.e USFDA, EMA, TGA, ANVISA, ICH - GCPs requirements for smooth and quality work in clinical research.
Performing self-quality check of above documents (i.e. protocol, ICF, CRF etc.)
Be a team member seamlessly coordinating with other team members, various department and with external clients.
ReClin Pharma Services (September 2020 to January 2021):
Responsible for arranging on-site visits and other logistics.
Partners with project team members to perform clinical monitoring for various BA-BE and phase-I trails.
Responsible to perform comprehensive site management activities. Provide high-level consultative services to site personnel by coordinating and disseminating all pertinent data regarding study protocols, Case Report Forms, TMF, amendments if any, study reports and other study related documents as per GCP/applicable regulatory guidelines.
Performs Qualification, Initiation, Monitoring.
Reviews ethics committee documents like registration of IEC/IRB, SOP, approval letter etc.
Works with research site personnel to ensure all research activities are run compliantly and according to protocol, SOP and as per GCP/applicable regulatory guidelines.
Ensures compliant recording and reporting of data generation during the conduction of the trail.
Department: CPMA
Role: Senior Manager (Duration: April’ 2018 to September 2020):
Roles & Responsibilities:
Responsible for supervision of protocol writing group for all routine activities.
To ensure all protocols and related documents flow through various stakeholders and meet the committed timelines.
To supervise and ensure the ethics committee approval for all documents related to clinical studies and process involved therein.
To ensure finalization of protocols in coordination with internal department and sponsor as per required regulatory guideline, Sponsor Specifications and in compliance with the in-house standard practices.
Coordination with the sponsor, Business Development Team, Project Management Team and other stake holders to address the bottlenecks.
Mentoring the new joiners through Trainings, lectures, seminars and practical hand holdings.
Handling of regulatory/sponsor queries.
Manager (Duration: April’ 2016 to March 2018)
Asst. Manager (Duration: April’ 2013 to March 2016):
Responsible for supervision of protocol writing group for routine activities.
To ensure all protocols and related documents flow through various stakeholders and meet the committed timelines.
To supervise and ensure the ethics committee approval for all documents related to clinical studies and process involved therein.
To ensure finalization of protocols in coordination with internal department and sponsor as per required regulatory guideline, Sponsor Specifications and in compliance with the in-house standard practices
Coordination with the sponsor, Business Development Team, Project Management Team and other stake holders to address the bottlenecks.
Review and preparation of SOP.
Update team member regarding regulatory guidelines.
Executive (Duration: December 2007 to March 2016):
Roles & Responsibilities:
Designing of Protocols, Informed Consent Forms, Case record forms and other protocol related documents.
Preparation and implementation of SOPs at that site with team members.
Planning, Preparation & Submission of dossier to IEC/IRB for approval.
Preparation of dossier of clinical documents for regulatory submission (i.e. BE/CT NOC, Import License applications etc.).
Handling of regulatory/sponsor queries.
Having enough awareness to various regulatory guidelines i.e USFDA, EMA, TGA, ANVISA, ICH - GCPs requirements for smooth and quality work in clinical research.
Performing self-quality check of above documents (i.e. protocol, ICF, CRF etc.)
Be a team member seamlessly coordinating with other team members, various department and with external clients.
Project coordinator: (May 2003 to August 2007):
(Bioavailability, bioequivalence, Drug-drug interaction and phase-I trials for various regulatory authorities)
Designing of Protocols, Informed Consent Forms, Case record forms and other protocol related documents.
Correspondence with sponsor, IEC, Internal departments for trials related activities like designing of protocol, protocol approval, trial update, investigational products related issues, subject’s safety related issues along with the Principal Investigator / Head-Clinical Operation and with IEC Chairman / IEC representative.
Preparation & Submission of dossier to IEC/IRB for approval.
Clinical Monitor phase-I trail, BA-BE and DDI trials (In-house & assisting in Site monitoring)
Reviewing the screening record for checking eligibility of the subject.
ICF verification before administration of Investigational Product.
Reviewing the CRF for its completeness and correctness.
Planning and scheduling of project and other related activities.
To implement and monitor ICH-GCP procedures and SOP driven activities in the clinic. Responsible for the administrative, technical and scientific operations and management of the clinical department and facility.
Allocation of projects to project coordinators to effectively meet the timelines.
Coordination with other departments for data analysis, report preparation etc.
Updating staff member regarding change in the design and conduct of the trial.
Planning and conduct of the BABE studies.
Providing solution to problems and seeking guidance whenever necessary.
Protocol and SOPs training to the study personnel for better quality of trial.
Monitoring and reporting of clinical trial related activities.
Handling of Investigational product (from dispensing to archiving).
Informed consent form presentation.
Report generation and finalization of various regulatory submissions.
Calibration In-charge for Ahmedabad facility (data logger, thermometer, stethoscope, hygrometer, digital clock, blood pressure monitor, glucometer etc.
Pharmacy custodian in Ahmedabad facility.
Pharmacy custodian (December 2003 to May 2007):
Responsible for handling the investigational products of Bioequivalence/Bioavailability, Phase-I trails according to GCP and various regulatory requirement.
Resolving regulatory queries the various investigational products related issues.
To handle accountability of investigational products of various projects and return/disposal of investigational products with proper documentation.
Prepare pharmacy related SOPs.
To maintain the logbooks and other investigational products related documents of the pharmacy.
Calibration of instruments within the pharmacy.
To train study personnel for pharmacy related activities.
Achievements:
1
Handled more than 150 BA/ BE Trials
2
Involved in Set up of new clinical facility in Ahmedabad Lambda House 240 beds facility & Mumbai 42 beds facility.
3
Involved in set up of Pharmacy in Mumbai.
4
Mentored 5 M. Pharm fresher for Protocol writing.
Presentation:
Case study “Investigational product at workshop for GCP held at Lambda Therapeutic Research in June, 2005”.
Schedule “Y” guideline held at Lambda Therapeutic Research in November, 2005.
Medical writing in clinical research held at Lambda Therapeutic Research in September, 2009.
Previous Organization:
Lincoln Pharmaceuticals Pvt. Ltd. Ahmedabad (Duration: April 2001 to May 2003)
Roles & Responsibilities: Production/QA Chemist
Making a batch size of the particular product
Documentation and maintaining of daily log book.
Requisition of the raw material, primary packing material and secondary packaging material according to the batch size.
Well versed with IPQC procedure, calibration and validation of various aspects related to pharma production.
Having exposure for the documentation part in respect of WHO, GMP ISO 9002.
Knowledge of preparation of master formula card, batch manufacturing record.
Manufacturing and packing of tablet, capsule, liquid, ointment, oral rehydration salts and powder
Responsible for solving manufacturing problems, yields, machine output in terms of down times, productivity improved to good extent.
ACADEMIC CREDENTIALS
Bachelor of Pharmacy (B. Pharm) from Gujarat University, L.M college of Pharmacy, Ahmedabad.
Higher Secondary School Examination (10 +2) from GSEB board, Gujarat.
Secondary School Examination (10th) from GSEB board, Gujarat.
CONFERENCE / WORKSHOP / PRESENTATION
Workshop on Good Clinical Practice conducted by Lambda Therapeutic Research (October, 2003).
Workshop on Good Clinical Practice conducted by Lambda Therapeutic Research (October, 2004).
Workshop on ICH E3 GUIDELINE conducted by Lambda Therapeutic Research Ltd. (June, 2005).
Workshop on Clinical Research-From theory to practice conducted by Academy for Clinical Excellence Limited, (August 2005).
Workshop on applied GCP conducted by Lambda Therapeutic Research (October, 2005).
57th Indian Pharmaceutical Congress (I.P.C.) Hyderabad (December 2005).
Workshop on Good Clinical Practice conducted by Lambda Therapeutic Research (December, 2006).
Presentation of “Schedule Y”
Workshop on Good Clinical Practice conducted by Lambda Therapeutic Research (April, 2009).
Workshop on advanced Good Clinical Practice conducted by Lambda Therapeutic Research (October, 2011).
Workshop on advanced Good Clinical Practice conducted by Lambda Therapeutic Research (July, 2013).
Workshop on advanced Good Clinical Practice conducted by Lambda Therapeutic Research (November, 2014).
Trained on advanced Good Clinical Practice conducted by Lambda Therapeutic Research (December, 2015).
Presentation on “Medical writing-preparation of protocol”
PERSONAL DETAILS
Date of Birth : 07th February 1977
Nationality : Indian
Languages Known: English, Hindi & Gujarati
Sex : Male
Marital Status : Married
Computer literacy: Ms-office, Excel, Internet surfing
Hobby : Surfing net, reading
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