Hira Jawed
Endeavour Hills
Summary
An experienced Regulatory and Site Start up Specialist, developing and implementing activation strategies to streamline the regulatory, contractual, and budgeting processes for clinical trials. With a focus on team collaboration and efficiency, I help organizations achieve outcomes, accelerate site activations, and ensure smooth project execution. I provide tailored solutions while negotiating clinical trial budgets and contracts to minimize the overall clinical trial start up timelines.
Overview
9
9
years of professional experience
Work History
SITE ACTIVATION SPECIALIST 2
IQVIA
07.2023 - 10.2024
- Serve as the primary point of contact for investigative sites
- Perform Start up and Site Activation activities according to applicable regulations, SOPs and work instructions
- Distribute completed documents to sites and internal project team members
- Review and provide feedback to management on site performance metrics
- Review, establish and agree on project planning and project timelines
- Ensure monitoring measures are in place and implement contingency plan as needed
- Inform team members of completion of Regulatory and Contractual documents for individual sites
- Review, Track and Follow up the progress, the Approval and Execution of required documents such as questionnaires, CDAs, Regulatory ethics, Informed Consent Forms (ICF), and Investigator Pack (IP) release documents, in line with project timelines
- Provide local expertise to Site Activation Managers and project team during initial and on-going project timeline planning
- Perform Quality Control of Study Documents provided by local Clinical Trial Sites
- Update and maintain internal systems, databases, track tools, timelines, and project plans with accurate and complete project specific information
REGULATORY STARTUP SPECIALIST 2
IQVIA
10.2022 - 01.2023
- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary
- Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines
- Perform Start up and Site Activation activities according to applicable regulations, SOPs and work instructions
- Distribute completed documents to sites and internal project team members
- Prepare site regulatory documents, reviewing for Completeness and Accuracy
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information
- Review and provide feedback to management on site performance metrics
- Review, establish and agree on project planning and project timelines
- Ensure monitoring measures are in place and implement contingency plan as needed
- Inform team members of completion of Regulatory and Contractual documents for individual sites
- Review, Track and Follow up the progress, the Approval and Execution of documents, Regulatory, Ethics, Informed Consent Forms (ICF), and Investigator Pack (IP) release documents, in line with project timelines
- Provide local expertise to Site Activation Managers and project team during initial and on-going project timeline planning
- Perform Quality Control of Study Documents provided by local Clinical Trial Sites
- Perform Country Informed Consent Form (ICF) Champion tasks for Pakistan
- Perform Development Safety Update Report (DSUR) notification and submission to DRAP, NBC & LEC through lead country trial site for Pakistan
- Directly contact sponsors on specific initiatives
REGULATORY STARTUP SPECIALIST 1
IQVIA
09.2021 - 09.2022
- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary
- Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines
- Perform Start up and Site Activation activities according to applicable regulations, SOPs and work instructions
- Distribute completed documents to sites and internal project team members
- Prepare site regulatory documents, reviewing for Completeness and Accuracy
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information
- Review and provide feedback to management on site performance metrics
- Review, establish and agree on project planning and project timelines
- Ensure monitoring measures are in place and implement contingency plan as needed
- Inform team members of completion of Regulatory and Contractual documents for individual sites
- Review, Track and Follow up the progress, the Approval and Execution of documents, Regulatory, Ethics, Informed Consent Forms (ICF), and Investigator Pack (IP) release documents, in line with project timelines
- Provide local expertise to Site Activation Managers and project team during initial and on-going project timeline planning
- Perform Quality Control of Study Documents provided by local Clinical Trial Sites
- Perform Site ID Specialist tasks of Identifying and Engaging potential trial sites as per the Clinical Trial requirements.
RESEARCH ASSOCIATE
Clinical Trials Unit, Aga Khan University
04.2021 - 09.2021
- Study Coordinator for 'An International Multicentre Controlled Clinical Trial to evaluate 1200mg and 1800mg Rifampicin daily in the reduction of treatment duration for Pulmonary Tuberculosis from 6 months to 4 months (RIFASHORT Trial)' by International Consortium for Trials of Chemotherapeutic Agents in Tuberculosis (INTERTB) sponsored by St
- George's University of London
- Study Coordinator for 'An international randomized trial of additional treatments for COVID-19 in hospitalized patients who are all receiving the local standard of care (SOLIDARITY Trial PLUS)' by WHO
- Review Clinical Trial protocols, draft ERC and grant checklist for study review and approval
- Initiating institutional review process for acquiring study approvals
- Coordinate & provide patient care in compliance with protocol requirements specific to patients screening, recruitment, and scheduling study visit procedures
- Schedule and participate in relevant sponsor/monitoring audits
- Maintenance of regulatory and administrative study documents in accordance with Regulatory, Institutional requirements & ICH-GCP guidelines
- Maintain study documentation as per protocol & ICH-GCP requirements
- Review/monitor subjects for changes in health status, response to investigational product, AEs, compliance in use of investigational product, concomitant medication use, & protocol compliance etc
- Assist PI in managing & reporting of SAEs, annual/periodic reports for ERC & trial Sponsors
- Communicate/update PI regarding patient progress, & health status to ensure effective Clinical Trial implementation
- Facilitate all start up and close out requirements of the study
RESEARCH PHARMACIST
Clinical Trials Unit, Aga Khan University
05.2019 - 04.2021
- Ensuring compliance of clinical studies with the study protocol ICH-GCP Guidelines, Drug Regulatory Authority of Pakistan and Joint Commission International Accreditation requirements
- Supervising Research Pharmacy operations during WHO & DRAP audits
- Reviewing study protocols for feasibility planning and training respective staff for study conduct
- Investigational Product Procurement, Storage, Dispensing and Returns Management
- Revision of Research Pharmacy related Clinical Trials Unit Policies at Aga Khan University
- Study Budget development, Blinding & Code Breaking (if required)
- Study Coordinator for Prospective, Observational study evaluating the Incidence of Nausea & Vomiting in patients with Cancer receiving Carboplatin-based Therapy funded by TESAROTM (Protocol version 2.0)
- Study Coordinator for SOLIDARITY Trial by WHO
- Editor of the Clinical Trials Unit quarterly Newsletter and CTU website content writer
ONCOLOGY PHARMACIST
Department of Pharmacy Services, Aga Khan University Hospital
08.2016 - 05.2019
- Clinical cover for Paediatric Oncology and Haematology Clinical Rounds
- Assisting the supervisor on timely Revision of Hospital Policies regarding Oncology Pharmacy Practices at Aga Khan University Hospital
- Active Management of the Oncology Pharmacy during Inventory and Cash Audits
- Ongoing Surveillance of Non-Formulary Drug use for Targeted Intervention and Arrangement of timely supply of Non-Formulary Drugs when essential
- Drug Information Retrieval, Medical Literature Evaluation and Recommendation for Rational Drug use
- Maintenance of Pilot Project of Dose Banding to minimize Patient TAT & Pilot Project of Chemotherapy Preparation Validation
- Medication Reconciliation and determination of potential Drug-Drug Interactions or Drug-Disease concerns and providing consultation regarding potential side effects of Chemotherapy and supportive therapy for the management of ADRs
- Antibiotic De-escalation and targeting
- Determination of Therapeutic Care Gaps, recommending appropriate resolutions, and counselling patients on existing interventions
- Co-authored an abstract entitled 'A Prospective Study to Evaluate Anticipatory CINV and Rationalize Antiemetic Therapy in Single Centre Tertiary Care Hospital' (April, 2016)
- Presented a Video Tutorial for USP 800 Specifications for Hazardous Drug Compounding and Cleanroom Pharmacy Operations for the 1st International Paediatric Conference (April, 2016)
Trainee Pharmacist
Aga Khan University Hospital
07.2015 - 06.2016
- Developed a deep understanding of various pharmacy software programs to optimize efficiency during daily tasks such as prescription filling, medication dispensing, or inventory management.
- Counselled patients on new medications and OTC products.
Education
Pharm.D -
Hamdard University
12.2014
Intermediate - Pre-Medical
D.A. Degree College for Women Phase VIII
06.2009
O levels -
Beaconhouse School System
06.2007
Skills
- Site activation
- Regulatory submissions & compliance
- Ethics Submissions
- Budget & contract negotiations
- Document review & Quality control
- Contingency planning
Accomplishments
- Awarded the Ovation award in the IQVIA Impact Program as “Recognition for advice on local regulations as well as prompt preparation of submission packets & efforts to facilitate country selection in short timelines.”
- Awarded Certificate of Appreciation for valuable contribution towards JCIA Reaccreditation of Aga Khan University Hospital (September 2018)
Clinical Trials Experience
Phase 3, 1, Gastrointestinal Cancer, Phase 3, 8, Non-small cell lung cancer (NSCLC), Phase 3, 2, Cardiovascular Disease, Phase 3, 12, Renal Cell Carcinoma, Phase 3, 6, Neovascular (wet) Age-related Macular Degeneration, Phase 3, 5, Influenza (Vaccine Trial), Phase 3, 8, Malnourishment, Phase 3, 5, Refractory or Unexplained Chronic Cough, Phase 3, 5, Haemophilic Arthropathy, Phase 3, 1, Hepatitis Delta, Phase 2, 1, Ulcerative Colitis, Phase 3, 8, COVID-19 (Treatment Trial), Phase 2/3, 6, COVID-19 (Treatment Trial), Phase 2/3, 10, COVID-19 (Treatment Trial), Phase 3, 11, COVID-19 (Treatment Trial), Phase 3, 7, COVID-19 (Vaccine Trial), Phase 3b, 9, COVID-19 (Vaccine Trial), Phase 3, 4, COVID-19 (Vaccine Trial), Non-interventional Real-World Study, 2, Advanced non-small cell lung cancer & Advanced liver (hepatocellular) cancer, Non-interventional Retrospective Real-World Study, 5, Type 2 Diabetes Mellitus, Phase 3, Pulmonary Tuberculosis, Phase 3, COVID-19 (Treatment Trial), Phase 2/3, COVID-19 (Treatment Trial), Phase 3, COVID-19 (Vaccine Trial), Phase 3, Anaemia in Pregnancy, Phase 3, Candidiasis including Candidemia, caused by Candida Auris, Phase 3, Fungal Diseases that are Refractory to or Intolerant of Standard Antifungal Treatment, Phase 3, Acute Severe Diarrhea amongst Children in Low resource settings, Phase 3, Perioperative Bleeding, Venous Thrombosis & Arterial Thrombosis, Phase 3, Prevention of Maternal and Neonatal Death/Infections, Phase 3, Pulmonary Tuberculosis
Professional Trainings
- Participated as a speaker on “Investigational Product Management” in the Advanced Training on Research Administration & Grants Management organized by the Department of Paediatrics & Child Health & Institute for Global Health & Development (June 21-25, 2021)
- Conducted Paediatric Hematology/Oncology Workshop for Nursing Staff (December 5th-7th 2017) and Care of Patients Receiving Cytotoxic Drugs Workshop for Nursing Staff (June 14th 2017)
- Conducted theMinimizing Misadventures in Paediatric Oncology and Hematology workshop in the 4th International Pakistan Society of Paediatric Oncology Conference (March 8th 2019)
Professional Seminars & Projects
- Quality Improvement Project for “The Development & Implementation of Institutional Anti-emetic Guidelines for Adult Oncology Patients”.
- Participated as a delegate in the 1st International Conference on Patient Safety: Patient Safety Right or a Privilege on 7th-8th May 2016.
Languages
English
Full Professional
Urdu
Limited Working
Timeline
SITE ACTIVATION SPECIALIST 2
IQVIA
07.2023 - 10.2024
REGULATORY STARTUP SPECIALIST 2
IQVIA
10.2022 - 01.2023
REGULATORY STARTUP SPECIALIST 1
IQVIA
09.2021 - 09.2022
RESEARCH ASSOCIATE
Clinical Trials Unit, Aga Khan University
04.2021 - 09.2021
RESEARCH PHARMACIST
Clinical Trials Unit, Aga Khan University
05.2019 - 04.2021
ONCOLOGY PHARMACIST
Department of Pharmacy Services, Aga Khan University Hospital
08.2016 - 05.2019
Trainee Pharmacist
Aga Khan University Hospital
07.2015 - 06.2016
Intermediate - Pre-Medical
D.A. Degree College for Women Phase VIII
O levels -
Beaconhouse School System
Pharm.D -
Hamdard University
Similar Profiles
Megan MunroeMegan Munroe
Associate Scientist at IQVIAAssociate Scientist at IQVIA
Lokesh ALokesh A
Salesforce Engineer-2 at IQVIASalesforce Engineer-2 at IQVIA
Arvindh GVArvindh GV
Applications/Software Developer II at IQVIAApplications/Software Developer II at IQVIA