Clinical Research Trial
Resume:
Page *
CURRICULUM VITAE
MOHAMMED JAVEED ULLAH
PHARM-D, MHM, MS Health Informatics.
***************@*****.*** Boston,MA
Objective:
To oversee and manage the clinical research and clinical trial processes and plan adequate oversight and monitoring during the trial verification to ensure accurate reporting of results at end of the trial. To work in a challenging environment that provides generous opportunities for learning and to work in a pragmatic way in an organization where I can show my talent and enhance my skills to meet company goals and objectives with full integrity.
Professional Experience and Skills:
● Seven years of experience in Clinical Research, TMF management and periodic review activities.
● Manages and oversees the day -to-day operations in the administration of clinical trials activities at the site level.
● Regular Interfaces with current and potential clinical trial participants to determine eligibility and consent of study participants in alignment with clinical trial protocols.
● Contributes to the training of clinical trial staff and accountable for compliance with the operational requirement of clinical trial.
● Manages participant visit scheduling and technical troubleshooting, escalating issues to the appropriate individuals.
● Solicit and record safety information regarding safety events and preparing safety event documentation for the review by the PI
● Provide accurate timely data collection, documentation, Data entry and reporting.
● Support the regulatory staff in the maintenance of regulatory documents in the maintenance of regulatory documents.
● Maintain regular contact with PI and team to review study details.
● Maintenance of study supplies and issue appropriate participant stipend.
● Ensure timely response to queries and documentation of study related issues.
● Oversee the organization of equipment and study supplies to facilitate uninterrupted study session.
● Conducting trail visits, processing all samples and shipping to central laboratory.
● Maintaining study source, Entering data in EDC and query resolving.
● Conducting all study specific assessments like Vital signs, and ECG.
● Conducting remote and onsite qualification, initiation and monitoring visits as per the monitoring plan for the assigned study.
● Preparation of site visit reports within the stipulated timelines as specified in the company’s SOP.
● Training and development of site team and resource management.
● SAE reporting as per the regulatory requirement and its management.
● Management of regulatory requirements.
Page 2
● In process monitoring visits for first patient dosing in the study.
● Experience of working in biosimilar studies.
● Communication with Site teams and Vendors.
● knowledge of New Drugs and Clinical Trial Rules 2019
● ICH-GCP E6 (R2), Indian ICMR Guidelines and Declaration of Helsinki.
● Response Evaluation Criteria for Solid Tumor (RECIST) Criteria vs. 1.1
● Handling CTMS, Electronic Data Capture and Clinical imaging assessment systems.
● Handling of Microsoft office (Word, Excel, Power point).
● Assisting with the QA /QC team for internal audits.
● CAPA Management and assisting with sites.
● Issue escalation and resolution management.
● Quality data management and Reporting.
● Good documentation practices (ALCOA+)
● CTCAE V 5.0 Safety Reporting
● Training to internal team and oversight the team
● Vendor management and conduct performance review with external vendors. Academics:
MS – Health Informatics - (2022 - 24), New England College, Hennikar, New Hampshire. (Continued….) Coursework: Principals of Health Informatics, Introduction to Health Economics and Outcomes Research, SAS, R, Epidemiology, Biostatistics, Data Analytics in Healthcare, Cloud Computing Concepts, Legal Compliance in healthcare, Database design, IT Project Management. MHM - Master of Hospital Management - (2017 - 19), Deccan School of Hospital Management, Hyderabad. Doctor of Pharmacy (Pharm-D) - (2008 - 14), Deccan School of Pharmacy, Hyderabad. Community Involvement:
Volunteer and educator on pulse polio. Pulse Polio immunization program February 2011.
Volunteer - Grace cancer foundation’s- Mega Cervical and Breast cancer screening Feb 2016.
Cancer Awareness Educator. Grace cancer foundation, March 2016.
Participant GUINESS WORLD RECORDS for Screening 2790 participants for Breast Cancer. Page 3
Future Aspirations:
To work in Global clinical trials which will give enhancement in career growth and opportunity to travel international visits.
Desire to work in rare diseases therapeutic area as I am very enthusiastic to learn new things.
Desire to work with new technologies and new trends in drug development. Employment Experience:
From To Employer Designation
Mar 2020 Aug 2022
Cliantis Clinical Research – Mythri
Hospital Mehdipatnam, Hyderabad.
In House Clinical Research Associate.
May 2016
Feb 2018 Continental Hospitals, Hyderabad. Sr Clinical Research Coordinator. May 2015 Apr 2016
BIBI General Hospital & Cancer
Centre, Hyderabad.
Clinical ResearchCoordinator.
July 2014 May 2015
Sai Sanjeevini Hospitals, Kothapet,
Hyderabad.
Intern Clinical Pharmacist.
Key Deliverables:
● Identify and pre screen potential investigators and their facilities.
● Prepare and/or customize patient information and consent forms.
● Complete and/or co ordinate ethics submissions in partnership with selected sites.
● Preparation of Clinical trial and confidentiality agreements, Negotiate trial budgets / contracts with sites.
● Conduct routine site monitoring visits
● Facilitate regulatory authority clinical trial applications/notifications.
● Ethics Committee Dossiers submissions, follow up for ethics committee approval and ethics committee query resolution.
● Set up the study centers with appropriate trial materials and training.
● Assist at investigator meetings.
● Preparation of study required power point presentations, study Manuals and logs forms.
● Check that data entered into data collection forms called case report forms (CRFs) is complete and is consistent with patient clinical notes (a process known as source data/document verification (SDV)).
● Writing reports for all communications and visits with study sites in Clinical trial management systems.
● Facilitate AE and SAE management with the site team.
● Help sites solve any problems they may have with recruiting and retaining patients, conducting the study, collecting data, etc.
Page 4
● Assist in some data management activities, such as reviewing and helping site staff answer queries on the data collected.
● Spend considerable time filing and collating trial documentation and reports
● Complete drug accountability for all trial supplies
● Preparing and monitoring trial budgets.
● Handling of e-TMF and upload the site documents periodically after completion of site visits.
● Site Audit readiness act as a mentor between sites and co-monitors.
● Archiving study documentation and correspondence
● Update the Study specific trackers and share with CTA team
● Supervises the CTA in maintaining and updating trial master files on regular basis; Responsible for ensuring compliance to GCP, applicable SOPs and applicable regulatory requirements.
● Assists CPMs in studying start-up activities, regulatory process and execution of study related agreements.
● Ensure proper escalation of site/project related issues to project manager in timely manner.
● Negotiate study budgets with investigators and ensure that timely payments are made to the site as per guidance from project manager.
Projects Work experience:
Phase of
Trial
Therapeutic
Area
Indication
Regulatory
Submission
Phase-III Oncology
HER 2 Positive Metastatic
Breast Cancer
EMA
Phase-III Oncology
HER 2 Positive Early Breast
Cancer EMA
Phase III Oncology NSCLC DCGI
Phase IV Oncology
Metastatic Colorectal
Cancers DCGI
Phase-IV Gastroenterology Left sided/ Distal Ulcerative Colitis DCGI
BE/PK Oncology
MBC after failure of previous
Chemotherapy. USFDA
Electronic Data Capture System Experience:
● Medidata EDC/Rave
● Oracle RDC Onsite
● IWRS- Octal soft
● Octal soft CTMS
● Clinical Imaging -ICL CLIN spa Software
● Octal soft e-TMF
● D-Soft lambda image uploading database
Page 5
Training and Certification:
● GCP Certification Mythri Hospital Mehdipatnam
Regulatory Inspections/Audit experience:
Conduct the audit readiness at investigate sites and experienced the several regulatory audit as follows
DCGI
NABH
USFDA
Research Publications
1) Sadiqua A, Nasir M, UN Reddy, JN Rao, Sana A, Adil, Javeed U. A Study on Assessment Of Parental Understanding of Pediatric Medical Prescriptions. International Journal of Medical Research and Health Sciences.2014; Vol3(3):541-546.
2) Maazuddin,Hazari,HasanAshfaq,Javeedullah,NasirMohiuddin,Baig Mirza. Training In the Use of Inhalation Devices and Respiratory Improvement In Asthma And COPD Patients: Before- After Experimental Study. Journal of Advances in Pharmaceutical Sciences2014; Vol5(5): 2314- 2320. 3) Nasir M,SanaA,MSAdil,SAnjum,UNRedddy,JNRao,JaveedUllah. Alleviating The Monetary Load By Switching To Generic Drugs. International Journal of Medical And Pharmaceutical Sciences. 2014;vol4 (12) : 04-07.
4) UNReddy, Sadika, NRao,Chacham,NasirM,Sana,Adil,Javeedullah. Evaluation Of Lucidity In Interpretation of Medical Prescriptions Written In Pediatric Outpatient By The Parents And Attending Pharmacists. ejpmr, 2015,2(4), 204-213 5) B Sugunakar, U N Reddy, Mohd Nasir Mohiuddin,Altaf n, Mirsum Sam, JaveedUllah. A Study on Efficacy Of Intra-Nasal Midazolam Spray In Pediatric Seizure Patients: A prospective Study. Innovative Journal of Medical Sciences.2016. 6(3) 98-100. 6) Maazuddin, Amer, Mohiuddin, Adil, Mir, Nasir Mohiuddin, Javeedullah, Shahid.
(2013). Respiratory Tract Is The Epicentre Of Antibiotic Resistance. 2013; (3);7168- 7174.
7) Amair k, Neamthullah, Omer, Javeed, NasirM, Mir S,Maazuddin. Respiratory Depression due to clonazepam and fluconazole interaction: Case report and Discussion. Indo American Journal Of Pharmaceutical Research. 2013; Vol 3(9): 7140-7145. 8) Maazuddin, NasirM, JaveedU, Faqruddin, OmerK, SanaA .Meconium Aspiration Syndrome With Complicated Neonatal Sepsis. An International Journal of Advances in Pharmaceutical Sciences. 2014; Vol 5(4) : 2197 -2199.
Contact this candidate