Oversighting Phase I/IIa (Solid Tumors) and Phase IIb (Prostate Cancer) study (US Sponsored)1. Responsible for drafting and implementation of Project Management Plan2. Responsible for oversight of CRAs and sites3. Point of contact for Sponsor and Vendors4. Responsible for training and monitoring of CRAs 5. Planning Study Start Up activities6. QC, Regulatory and Ethical Compliance 7. Managing study trackers including Payments, Pre-Screening, Enrollment, IP, ADIs… Show more Oversighting Phase I/IIa (Solid Tumors) and Phase IIb (Prostate Cancer) study (US Sponsored)1. Responsible for drafting and implementation of Project Management Plan2. Responsible for oversight of CRAs and sites3. Point of contact for Sponsor and Vendors4. Responsible for training and monitoring of CRAs 5. Planning Study Start Up activities6. QC, Regulatory and Ethical Compliance 7. Managing study trackers including Payments, Pre-Screening, Enrollment, IP, ADIs, Risk Assessments,. Essential documents, MVs, eTMF, Safety8. Responsible for central IRB (Advarra/WCG) study submissions 9. Devising and implementing Recruitment strategies to meet planned enrollment target10. Devising and planning smart tools to improve data metrics Show less

Clinical Trials Oversight (All Phases)Remote monitoring Site Selection, initiation, Planning, Monitoring and ExecutionTeam Building and Training Budgeting and AgreementsStudy Logistics (IP Depot, IATA, Consumables, Reference Laboratory Agreements)Regulatory and Sponsor inspection and auditRA and EC SubmissionsEnrollment Strategy and ImplementationQuality Control of Clinical Studies

• Responsible for Conducting Clinical Trials on Natural Medicines (Sponsored by Qarshi)• Identification and collaboration with potential sites and CROs• Responsible for identification, development and launch of market potential products • Preparation of Protocols, CRFs, ICFs and other essential documents • Literature review and research content writing related to Natural Medicinal products• Liason with RA and ECs• Planning formulation, marketing strategy and Launch of… Show more • Responsible for Conducting Clinical Trials on Natural Medicines (Sponsored by Qarshi)• Identification and collaboration with potential sites and CROs• Responsible for identification, development and launch of market potential products • Preparation of Protocols, CRFs, ICFs and other essential documents • Literature review and research content writing related to Natural Medicinal products• Liason with RA and ECs• Planning formulation, marketing strategy and Launch of Products Show less

• Responsible for On time training and reporting of ROCHE delegated tasks and trainings • Responsible for timely submission of AEs and SAEs and SUSARs• To conduct Trial according to the Study Protocol with given/assigned Delegated task• Reviewing, Handling reports of different sites• Understanding clinical trial protocol and ensuring the same • Adverse events reporting, informed consents and IRB and related regulatory and ethical protocols • Responsible for complete site… Show more • Responsible for On time training and reporting of ROCHE delegated tasks and trainings • Responsible for timely submission of AEs and SAEs and SUSARs• To conduct Trial according to the Study Protocol with given/assigned Delegated task• Reviewing, Handling reports of different sites• Understanding clinical trial protocol and ensuring the same • Adverse events reporting, informed consents and IRB and related regulatory and ethical protocols • Responsible for complete site management (site selection, site time lines to site closure)• Regular updates to study management about site performance by attending teleconferences• Correspondence with study manager on site related issues • Complete site file review and documentation• Responsible to provide all safety information of all clinical trials to the Sponsor and Regulatory authorities Show less