Ahmad Kamal

Ahmad Kamal Email and Phone Number

Clinical Research Professional ǀ CPM ǀ Sr. CRA ǀ QC & QA ǀ Regulatory Services for Trials @ OrciTrials
Ahmad Kamal's Location
Lahore District, Punjab, Pakistan, Pakistan
Ahmad Kamal's Contact Details

Ahmad Kamal work email

Ahmad Kamal personal email

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About Ahmad Kamal

As Clinical Research Professional• Served as local study accountable person and led 14 projects• Preparing proposals, budgets, strategies, vendor management, project plans, milesontones and POC for stakeholders• Monitored trial from start-up till close-out with all queries and issues resolution within stipulated budget and timelines• Formulated SOPs, directive documents, processes and mechanisms, CAPAs and ensured its implementation• Developed training roadmap and material under the guidance of organization management• Remained point of contact while ensuring compliance with global expectations and regulations such as per ICH-GCP, EU/FDA guidelines and local regulations• Performed Quality Assurance activities for more than 13 projects/vendors of different countries and generated reports for audit findings with their categorization• Proven knowledge of ICH-GCP and associated guidelines - Received satisfactory score in evaluation by QC team of GSK EMAP• Experience of working in different therapeutics such as biologicals, cardiovascular, oncology, infectious, opthalmology diseases in both adult and pediatrics population• In terms of team management, I developed a team of 12 CRAs and CTAs, with one-member earning recognition at the regional level• Identified training needs and imparted training via face-to-face or virtual methods as local trainer• Acted as regulatory contact person, prepared and submitted regulatory dossiers for four projects and one organizational license • Developed, enhanced, and maintained a business risk and continuity plan at the project and departmental levels for smooth business functions• Capable of performing multitasks with priority settings - established and run eight sites efficiently at one time while handling additional departmental roles• Proficient in learning and handling IT tools related to trials and MS-Office• Available to travel locally and internationallyFor any research related discussion, feel free to contact at:Email: ahmadkhrl@gmail.comMob: +92-333-8114643

Ahmad Kamal's Current Company Details
OrciTrials

Orcitrials

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Clinical Research Professional ǀ CPM ǀ Sr. CRA ǀ QC & QA ǀ Regulatory Services for Trials
Ahmad Kamal Work Experience Details
  • Orcitrials
    Clinical Project Manager
    Orcitrials Jul 2023 - Present
    Lahore, Punjab, Pakistan
    • Responsible in development study proposal, budgets, project plan with responsibility matrix, key milestones and study deliverables under management vision• Led the project/bid meetings with stakeholders while gauging sponsors expectation and providing workable solution for potential projects• Led clinical operations and actively contributed to organizational strategy development, applying SWOT and SMART principles to align with business dynamics as per management expectations• Developed project management plans, including monitoring, risk management, communication, and essential documents, ensuring ICH-GCP and regulatory compliance• Playing a key role in project delivery by managing resources, mentoring staff, and facilitating communication between sponsors, OrciTrials management, and executing sites through CRAs• Met clinical study goals by tracking milestones, conducting risk assessments, developing mitigation plans, overseeing monitoring and reviewing reports, and implementing CAPAs over identified issues with quality checks to ensure study quality• Conducted workshops for internal & external stakeholders on ICH-GCP basics and advanced concepts• Liaising & working closely with Regulatory Authorities of assigned countriesAs Quality Assurance Auditor• Performed audit and lead quality assurance activities for 04 projects including clinical & vendor quality audits with report generation • Tracking audit findings and shaping departmental strategies to achieve service excellence• Developing internal quality management system based on risks with QA at OrciTrials• Reviewing, and improving SOPs, processes and directive documents of OrciTrials as per current market practices and ICH-GCP standards
  • Promedixcro Pvt. Ltd.
    Clinical Research Professional I Qc & Qa I Consultant I Visiting Faculty
    Promedixcro Pvt. Ltd. Jan 2018 - Jul 2023
    Lahore, Punjab, Pakistan
    • Development, enhancement, and formulation of organizational infrastructure for clinical research operations in collaboration with the team managemento Development of working SOPs and guidelines essential for clinical research of the organization as per international and local guidelines o Development of training roadmap and coaching of team members under QA guidanceo Task oriented training, task assignment and evaluation of team members as per company SOPso Development and implementation of internal quality control framework and competency evaluation plan o Development and implementation of departmental Risk Management & Contingency Plano Establishment a network with vendors for execution of smooth clinical research activities o Liaising with state and academic institutes and vendors as per organization strategic plan for building trusted relationshipQuality Assurance Team Player • Assisted in performing quality assurance activities on the assigned tasks as per the organization audit SOPs for more than 10 sites of different countries (USA, Spain, India, Mexico, Nepal, Kenya and Pakistan). Expertise in identification of ICH-GCP deficiencies and ALCOA + CEEA issues through review of:o Trial Master File (TMF)o Source Documents and eCRFs (SDR and SDV)o IRB/EC & Regulatory documentation and approvalso Monitoring visit reportso IP managemento Sponsors/CROs SOPs • Generated reports of identified issues with its categorization for lead auditor review and finalizationConsultan to P&SHD, Government of Punjab• Functionalized NCDs department in 43 hospitals over Punjab• Trained more than 500 hundred doctors and paramedics over diabetes, CRDs and Cancer Guidelines• Established Well Women Clinics across Punjab for Breast & Cervical Cancers and GDM• Formulized and implemented centralized monitoring & evaluation system over 80 departments more than 100 hospitals in PunjabWorked as visiting faculty to University of Central Punjab, Lahore
  • Glaxosmithkline Pakistan
    Senior Clinical Research Associate
    Glaxosmithkline Pakistan Feb 2014 - Jan 2018
    Lahore, Pakistan
    • Successfully monitored Pakistan’s first biological study of the organization by meeting target allocation of 10 subjects within timelineso Established a robust infrastructure of cold chain management, not present previously in the organization for trialso Formulated a realistic & achievable budget of the study.o Performed feasibility and selection process – One site achieved 200% of the target recruitment goal.o Resolved conflict in the agreement by liaising with GSK and Site teams o In a time when study initiation was delayed due to authority approvals, organized local Investigator’s Meetings and prepared sites in a way that first subject recruitment mark was achieved soon after the site initiation. o Monitored sites by assuring high quality data delivery, recruitment on target and maintenance of documents per ALCOAC rule (Attributable, legible, contemporaneous, original, accurate and complete) as defined by GCP and Regulatory standards and warranted that Trial Master File is up-to-date all the times.o Exhorted and collaborated with sites to develop processes for delivery of work guarded by quality o Conjoin efforts to inculcate self-driven work yielded query/site response well within time-frame • Proficiently mediated Audits and Assessments o GSK Audit team assessment at the biological's site and on the cold chain management process of the projecto Independent third party audit of GSK projectso Management monitoring (Quality Assurance) activity by EMAP manager in Pakistan• Got certification in competency as Senior CRA after achieving “Satisfactory Score” in competency evaluation conducted by regional manager• Won first prize in the debate competition held within Pakistan and India Teams on topic “Should Pharma companies continue to provide IP after trial ends”.• Became Lead contact for Biologicals due to extensive expertise and scrupulous knowledge of the biological processes in Pakistan.
  • Glaxosmithkline Pakistan
    Backup Local Trainer
    Glaxosmithkline Pakistan Feb 2014 - Jan 2018
    Lahore, Pakistan
    • When assigned to this role, organized and hosted regional training meeting in Pakistan in which three countries participated. It was profoundly done and meeting its objectives by identifying training gaps and structuring topics & training material with the presenters with minimal cost investment. • Catalogue gap on guidance over “LAR during ICF process” and cofunction with different GSK departments to develop directive document on the needful topic.• Mediated LOC team to create a local ICF for Pakistan which was not present previously.• Conducted several training sessions within LOC and at regional training meetings either on request or sensing need for training on a topic.
  • Glaxosmithkline Pakistan
    Backup Local Regulatory Contact
    Glaxosmithkline Pakistan Feb 2014 - Jan 2018
    Lahore, Pakistan
    • Efficiently prepared local regulatory authority’s clinical trial dossier for study approval of the three assigned projects within due timelines which received no objections and subsequent approvals.• Furnishing the requirements of regulatory authority either by preparing periodic updates or reply of the queries raised by the authority.• By liaising with the authority, playing key role in organizing meeting and fulfilling the requirements laid by them.
  • Glaxosmithkline Pakistan
    Team Manager
    Glaxosmithkline Pakistan Feb 2014 - Jan 2015
    Lahore, Pakistan
    • Managed effectively a team consisting of CRA and Traineeo Mentor my team on all trial related aspects especially focusing on new approaches being adopted in monitoring e.g. Risk Base Monitoring (RBM), eDx, eTMF etc.o My team won appreciation at regional level for system support under my supervision.
  • Glaxosmithkline Pakistan
    Clinical Research Associate
    Glaxosmithkline Pakistan Feb 2011 - Feb 2014
    Lahore, Pakistan
    • Superintended and monitored efficiently Pakistan largest recruiting multicentre multicounty study of GSK Pakistan.o Carefully crafted budget for the three site and study was successfully conducted within the proposed budget.o Precise activity was done on feasibility and site selection which guaranteed target recruitment by all the sties in the study. o When assigned to the project, Pakistan was lagging from other countries, did a successful combine Local Investigator Meeting and prepared the site with extensive training which enabled Pakistan to hit 1000 subjects target landmark of recruitment merely in six-months period.o Warranted with my quality time and guidance to the sites, query reply and work progress remained at standard and study manager praised this at the regional level.o eTMF and site file remained updated with the course of study and no complaint was received from the vendor company checking eTMF of the study.• Bio-vaccine Trialo Exertive efforts and contributions with Investigators, GSK Legal, Medical and Central team resulted in resolution of the concern raised by IRB over OPV Vs IPV vaccine use in Pakistan.o Prepared and got approval of another site in a month of time when regulatory approval was struck to compensate for the time lost to meet recruitment target. • Got training on GSK Cardiovasular and Oncology Project and provided support as monitor on “when and where” basis.o In Pakistan, my assigned site completed query resolution at the earliest basis and Pakistan was praised for query completion activity in the region for one of the assigned project.• Provided support in the audit preparation for two projects and no concern was raised by the auditors over the assigned tasks.• Keenly participated in all local and regional meetings within and outside the country and presented assigned topics during the meetings.
  • Glaxosmithkline Pakistan
    Junior Clinical Research Associate
    Glaxosmithkline Pakistan Oct 2010 - Feb 2011
    Lahore, Pakistan
    • Soon after joining GSK, won “Bingo Bonanza Prize in myLearning” in GloxoSmithKline Pakistan Limited organization by completing highest number of learning modules• Successfully and effectively completed assigned tasks on monitoring, departmental activities. Kept up-to-date trackers and developed ToR (Transfer of Responsibility) document with help of Line Manager for the very first time in the departmental history.• Completed Monitoring@GSK Part-1 training in Johannesburg, South Africa in 2011 with a successful co-monitoring visit with Line Manager and soon after that promoted to take full responsibility of the study as a Monitor (CRA) in less than a one year of time well before timelines stated by departmental processes due to development of required expertise.
  • University Of Sargodha, Pakistan
    Internee Scientist
    University Of Sargodha, Pakistan Jun 2009 - Aug 2009
    Sargodha, Pakistan
  • Fazal Din'S Pharma Plus
    Community Pharmacist
    Fazal Din'S Pharma Plus Jun 2006 - Aug 2006
    Lahore, Pakistan
    Internship during the Pharm-D Programme

Ahmad Kamal Skills

Clinical Trials Pharmaceutical Industry Clinical Monitoring Gcp Ich Gcp Clinical Development Ctms Therapeutic Areas Regulatory Submissions Cro Oncology Sop Clinical Data Management Drug Development Pharmacovigilance Good Clinical Practice Standard Operating Procedure

Ahmad Kamal Education Details

Frequently Asked Questions about Ahmad Kamal

What company does Ahmad Kamal work for?

Ahmad Kamal works for Orcitrials

What is Ahmad Kamal's role at the current company?

Ahmad Kamal's current role is Clinical Research Professional ǀ CPM ǀ Sr. CRA ǀ QC & QA ǀ Regulatory Services for Trials.

What is Ahmad Kamal's email address?

Ahmad Kamal's email address is ah****@****ick.com

What schools did Ahmad Kamal attend?

Ahmad Kamal attended The University Of Lahore, University Of Sargodha, University Of Sargodha, University Of Sargodha.

What are some of Ahmad Kamal's interests?

Ahmad Kamal has interest in Learning New Software, Traveling, Internet And Computer Systems, Sight Seeing, Innovation In Everything, Knowledge And Knowing Traveling, Sports, Table Tennis Esp, Programs.

What skills is Ahmad Kamal known for?

Ahmad Kamal has skills like Clinical Trials, Pharmaceutical Industry, Clinical Monitoring, Gcp, Ich Gcp, Clinical Development, Ctms, Therapeutic Areas, Regulatory Submissions, Cro, Oncology, Sop.

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