Started as acting Project Manager in July, 2021.Main activities and responsibilities:Serves as the primary contact between the sponsor and the organization at theproject level.Ensures escalation pathways adhered to internally and externally (Rules ofEngagement – communication pathways).On projects where the scope requires, ensures clear delineation in responsibilitiesand communication pathways for secondary project leads (such as lead in aspecific region, lead… Show more Started as acting Project Manager in July, 2021.Main activities and responsibilities:Serves as the primary contact between the sponsor and the organization at theproject level.Ensures escalation pathways adhered to internally and externally (Rules ofEngagement – communication pathways).On projects where the scope requires, ensures clear delineation in responsibilitiesand communication pathways for secondary project leads (such as lead in aspecific region, lead for a specific vendor(s) or subset of delivery).Accountable for the overall delivery of the cross-functional project (time, cost,quality).Ensures financial stewardship at a project level by demonstrating an intimateunderstanding of the contract, resource alignment to budget, management of Outof Scope activity, drive the Con Mod process/negotiations and team execution totimelines.Establishes, communicates and manages customer expectations to achieveoptimal delivery during the projectDrives Risk Identification and Issue Resolution at project level (RBQM/RESOLVE).Ensures project team compliance with organization policies, SOPs, ICH- GCP,regulatory and project specific requirements.Achievements to date:two virtual Investigator's meeting performedenrollment goal is achieved before contracted timelines for rare disease studyInterim analysis milestone achieved as per target Show less

Main activities and responsibilities:• Managed the execution of project deliverables within contractual timelines and client expectations through all active phases (start-up, recruitment; maintenance; closeout and database lock) of a large clinical trial or multiple smaller trials• Managed clinical budget, escalated out-of-scope activities to the appropriate individualsfor inclusion in a contract modification• Managed contingency planning for data cleaning; reviewed the clinical… Show more Main activities and responsibilities:• Managed the execution of project deliverables within contractual timelines and client expectations through all active phases (start-up, recruitment; maintenance; closeout and database lock) of a large clinical trial or multiple smaller trials• Managed clinical budget, escalated out-of-scope activities to the appropriate individualsfor inclusion in a contract modification• Managed contingency planning for data cleaning; reviewed the clinical data listings; coordinated process for reviewing data listings by a clinical team; escalated quality issues recognized; and provided CRA retraining for quality data as needed• Participated in site recruitment and budget negotiations; provided contingency planning for meeting recruitment milestones• Prepared, organized and presented at Investigator Meetings• Tracked, reviewed, and distributed metric updates (regulatory, enrollment, CRF retrieval, subject visits, query, etc.) to external/internal clients/vendors• Prepared monitoring plan, was responsible for the implementation and training of standardized clinical monitoring processes within the study team• Performed oversight on the development of source documents, CRF/eCRF guidelines and other project-specific forms to be utilized during the study period• Provided leadership, coordination, and management of the PPD-customer joint projectteam through start-up, conduct, tracking, quality, and regulatory compliancemanagement and close-out activities• Performed review of pass-thru travel costs to ensure the most cost-effective travelpractices are being utilized by monitoring staff• Reviewed essential regulatory documents prior to transmittal to the client for release of initial investigational product• Acted as Global CTM for Rare Disease Study• Mentored new hired CTMs• Participated in two Bid Defense Meetings (the studies awarded to PPD)• Acted as Global Project Manager Show less

• Coordinated 5 phase III-IV clinical trials in various neurology indications from SSU tillDBL and close out.• Acted as Global CTM in two in parallel phase III studies in neurology/ psychiatry• Participated in 3 BID meetings and 3 KOMs.• Participated in Investigator meetings• Mentored 2 new hired CTMs.• Participated in multiple company initiatives.• Created various trainings for CRAs.

Main activities and responsibilities:Coordinated 3 phase III clinical trials in neurology indications till DBL and close out.

Main activities and responsibilities:served as primary contact for the clientmanaged the project contractual deliverables (timelines, budget, quality and client satisfaction)managed the study related risks including risk assessment/identification/management/escalation and suggestion of mitigation strategiesmanaged the project finances including vendor managementmanaged internal team and vendorsAchievements:- successful meeting of enrollment target 1 month ahead… Show more Main activities and responsibilities:served as primary contact for the clientmanaged the project contractual deliverables (timelines, budget, quality and client satisfaction)managed the study related risks including risk assessment/identification/management/escalation and suggestion of mitigation strategiesmanaged the project finances including vendor managementmanaged internal team and vendorsAchievements:- successful meeting of enrollment target 1 month ahead of schedule- successful interim DBL in time- successful DBL in time Show less

Main activities and responsibilities:Managed more than 10 phase II and III clinical trials in various indications:neurology, infectious diseases, hematology, oncology, immunology, anestheticsfrom study award till LSA globally.Participated in 12 BID meetings and 9 KOMs.Participated in multiple company initiatives.Conducted Instructor Led trainings for IHCRAs and SULs.

Managed more than 15 phase II and III clinical trials in various indications: neurology,infectious diseases, hematology, oncology, immunology, anesthetics at local level

ICH GCP; site management; feasibility; eTMF; CTMS

-indexing of patents in medicinal, biological and chemical fields -seeking for new trends in pharmaceutics-quality control-administrative functions-writing reports-assist on time planning for Chief of New Information Technologies Department-creating of marking strategy for new information product promotion -planning and analysis of current and future project activities -negotiations with partners and contractors-work with potential project participants and… Show more -indexing of patents in medicinal, biological and chemical fields -seeking for new trends in pharmaceutics-quality control-administrative functions-writing reports-assist on time planning for Chief of New Information Technologies Department-creating of marking strategy for new information product promotion -planning and analysis of current and future project activities -negotiations with partners and contractors-work with potential project participants and co-investors Show less

-creating of marking strategy for new information product promotion -planning and analysis of current and future project activities -negotiations with partners and contractors-work with potential project participants and co-investors

-research in the field of medicinal chemistry-planning and analysis of current and future project activities -seeking for new ideas for novel pharmaceutical products synthesis -writing patents-certification of novel pharmaceutical products -work with potential project participants -negotiations with patent experts

-participation in research projects of the lab-experiments in the field of nucleic acids chemistry-work on R&D projects with partners (MRC, Cambridge, UK) -supervision of diploma theses-supervision of PhD theses-lecturing-creating scientific publications