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Click here or scroll down to respond to this candidateCandidate's Name , MDEMAIL AVAILABLEcell: PHONE NUMBER AVAILABLE20+ years in the research industry working in first in human to late phase studies. Certification in project management and wide range of therapeutic indication. Have experience in global studies in various indications such as Depression, Anxiety, Migraine, Psoriasis, Asthma, Bronchitis, Diabetes, and osteoarthritis. 8-10 years of experience in oncology including immunotherapy, gene therapy, CAR-T.Professional ExperienceCTI Clinical Trial & Consulting Services (Apr2022 Present)Assistant Director, Clinical Project ManagementPlans implements, facilitates, and evaluates the full execution of assigned clinical trials; oversees management of multiple clinical trials from the planning phase to the analysis phase for delivery to client; may function as a global leadEnsures the operational aspects of the functional areas comply with International Council of Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines, and trial proceduresEnsures that assigned Clinical Project Managers (CPM) and/or Clinical Project Coordinators (CPC) coordinate the organization and implementation of a clinical trial and manages the activities between all functional areas and the client on assigned trialsServes as primary senior interface on the project with Executive Management at CTI and the sponsor; provide effective client management to prevent and mitigate trial issues; escalates identified trial, CPM, or CTI issues to Executive Management as needed; actively participates in resolution activitiesOversees preparation of the Project Plan and project timelines and monitors against project progress; ensures project activities comply with trial plans; provides suggestions and implements alternative solutions to problems with project timelines, schedules, resources, budgets, etc.; takes corrective action where necessaryAssesses resource needs with functional area managers and establishes appropriate project team in conjunction with CPM (if applicable); monitors ongoing resource needs for projectEnsures that appropriate project management tools are used to track and report project progress and metrics; ensures timely entry of project information by all team members throughout the life of the projectEnsures training of assigned project teams; participates in staff training dependent upon needs and expertiseOversees the management of budgeted hours by the CPM, who evaluates and manages regional project budget against project milestones; ensures that the CPM takes corrective measures where necessary to keep project in line with budget expectationsEnsures that the CPM assesses scope of work (SOW) against client contractual agreements and assists in changes of scope orders; provides review of changes in scope notifications and works with Business Operations to ensure completion of needed contract amendmentsSynthesizes and analyzes project information related to trial milestones in contacts and the sponsor expectations and reports the outcomes of that analysis to CTI Executive Management and the client; ensures that the CPM initiates corrective action as necessaryConducts or attends trial team and sponsor meetings; ensures that agendas and minutes are effectively prepared to facilitate trial communication and documentation of trial oversight, discussions, and decisionsProfessional Experience continuedReviews weekly and/or monthly project status reports (MSRs) prior to forwarding to client and assures the quality of those reports, as well as all other sponsor deliverables.Reports project progress, issues, and scope of work considerations to Executive ManagementProvides input for new business development (NBD) proposals, assists in project budget preparation / reviews, and represents project management services during NBD client presentations; participates in business recruitment and marketing activities; seeks NBD opportunities when appropriate and communicates these opportunities to Business Development (BD)Provides supervision, guidance, and mentoring to CPMs while encouraging independence and refining skills of the CPMs.Reviews and assesses internal and external quality assurance (QA) reports for assigned projects and ensures corrective action as necessary by the project management team.Provides leadership in process improvement activities and initiatives.Provides leadership and shares expertise with clinical operations staff; facilitates the development of reference and resource materials for CPMs and clinical operations.Effectively coaches and trains others in the CPM practices as well as professional development.Amgen (Nov2021 Apr 2022)Global Early Clinical Development ManagerLed study level planning of the overall clinical operation results.Developed early phase clinical operation strategy and contributed to the strategic scenario planning in clinical development planDeveloped and maintained study timeline and development of clinical protocol and informed consentContributed to the development and/or review of study-related documentation, including but not limited to monitoring plan, risk management tool, eCRF, manuals, training materials, safety and regulatory documents, and clinical study report, etc.Led clinical study team to identify, evaluate and select clinical sitesHandled the day-to-day operations of clinical trial at a global level and resolved issues escalated by the local study teamMaintained close collaboration with site investigators through regular and ad hoc investigator and site meetings, keeping investigators, often including key thought leaders, engaged to the studyTrained study team members and/or sites to conduct the studyLed and coordinated Dose Level Review meetings, communicates decisions of the meetings, and operationalize Dose Level Review meeting outcomes.Managed vendors and functional service providers (FSP)ICON LLC (Aug 2019 Nov 2021)Senior Project ManagerManaged and coordinated efforts of cross-functional project teams to support milestone achievement and managed study issues and obstacles.Professional Experience continuedEnsured consistent use of study tools and training materials and compliance with standard processes, policies, and procedures. Implemented continuous improvement activities for assigned projectIdentified quality issues within the study through regular review of site communications, monitoring visit reports, data flow information, and QA audit findings to implement appropriate corrective action plans. Escalated findings and action plans to appropriate partiesPrepared and presented project information at internal and external meetingsParticipated in proposal development. May lead bid defense presentations in partnership with BD and Senior Clinical Project Management staffDefined project workloads and assignments. Developed and oversaw maintenance of internal databases and project plans.Syneos Health (providing services to BMS, Clinical Division) (Jul 2017 Jul 2019)Senior Project Manager, Clinical OperationsOversaw interdisciplinary clinical research programsRepresented Syneos Health to the customer, ensuring satisfaction levels were maintained and program deliverables were communicated effectivelyLed clinical team to ensure quality, timelines, and budget managementResponsible for TMF Management Plan, quality, and completeness of TMF for assigned projectsAccountable for the financial performance of each project assignmentAccountable for all project deliverables for each project assignedEnsured studies were conducted in compliance with GCP, relevant SOPs, and regulatory requirementsAccountable for maintenance of study information on a variety of databases and systemsResponsible for study management components of inspection readiness for all aspects of the study conductOversight for development and implementation of project plansPlanned, coordinated, and presented at internal and external meetingsPrepared project management reports for clients and managementImplemented resource strategies to achieve project goalsDeveloped contingency planning and risk mitigation strategies to ensure successful delivery of study goalsParticipated in bid defense meetings where was presented as potential project manager/directorSupported proposal development through review of proposal text and pricing where was presented as potential project managerConvance Inc. (Jun 2016 Jun 2017)ContractSenior Project ManagerProject Manager oversaw and managed domestic, regional, and international clinical trialsRBM dashboard review and initial study risk assessmentReported on team performance against contract, customer expectations, and project baselines to managementProfessional Experience continuedLed problem solving and resolution efforts to include management of risk, contingencies, and issues. Developed proactive contingency plans to mitigate clinical riskIdentified quality issues within the study through regular review of site communications, monitoring visit reports, data flow information, and QA audit findings to implement appropriate corrective action plans. Escalated findings and action plans to appropriate partiesCollaborated with other functional groups within the company where necessary to support milestone achievement and managed study issues and obstaclesResponsibilities typically included developing and managing budgets, timelines, and quality guidelines for projects, thereby ensuring that expectations were met while identifying and mitigating risksProject Manager also compiled and drove documentation for the project, ensuring the accuracy and quality of regulatory data. Project Manager may have had line management responsibilitiesLed core project team and facilitated teams ability to lead extended/complete project team. Depending on size and scope of project, this job duty may be performed in collaboration with a Senior Project Manager and/or Project DirectorProvided input for the development of proposals for new work and project budgetsPrepared and presented project information at internal and external meetingsParticipate in proposal development. May lead bid defense presentations in partnership with BD and Senior Clinical Project Management staffIQVIA (May2015 Jun2016)ContractSenior Project ManagerManaged key client projects. Project Management responsibilities included the coordination and completion of projects on time, within budget, and within scopeOversaw all aspects of project. Set deadlines, assigned responsibilities, and monitored and summarized progress of projectPrepared reports for upper management regarding status of projectWorked directly with clients to ensure deliverables fell within the applicable scope and budgetCoordinated with other departments to ensure all aspects of each project were compatible and would hire new talent as needed to fulfill client needsEnsured consistent use of study tools and training materials and compliance with standard processes, policies, and procedures. Implemented continuous improvement activities for assigned projectsDeveloped study management plans, together with team assignments and accountabilities and oversight of database maintenanceServed as primary project contact with Sponsor to ensure communication was maintained and continuously improvedEnsured high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA teamPrepared and presented project information at internal and external meetingsParticipated in proposal developmentLed bid defense presentations in partnership with BD and Senior Clinical Project Management staffProfessional Experience continuedPAREXEL Intl. (2011 2015)Senior Site ManagerManaged all administrative functions of the CRO, including coordination of staffing, scheduling of day-to-day activities, as well as developed budgets for regulatory development and contract terms for the CRO. In charge of writing protocols, Manuals of Operations, Statistical Analysis Plans, and clinical trial design in Investigator initiated studiesExecuted preparation processes of various regulatory functions including IDEs, INDs, and paper submissions to support investigator-sponsored studiesManaged multiple sites, conducted Phase II and III clinical trials in all aspectsResponsible for Internal Audit ResolutionReviewed trip reports and managed CTS, CMA, and CRAsWorked with the Director to update project plansCommunicated directly with the Sponsor for weekly updateDeveloped and reviewed project specific documentsWorked as a liaison between the site and SponsorParticipated and presented in internal and external meetingsInvolved in resourcing for the projectNational Institute of Health/National Cancer Institute (2011)ContractClinical Project LeadMonitored site activitiesManaged study specific vendorsManaged the conduct of assigned clinical investigations and activities associated with clinical trialsManaged the interaction of appropriate departments and staff to support and maintain the clinical investigationsWorked as a line manager for CRAs and CTAs including hiring and reviewing their performance and monitoring reportsSupervised training programs to assure consistency and compliance in monitoring of clinical investigationsAssisted with preparation of department budgets, timelines, and project plansNegotiated contracts and budgets for assigned clinical investigators and vendorWorked in the DMC board, actively participated in AW, SAE initial reporting, follow-up, narrative writing, and resolution. Worked with the Medical Monitor for the patient safety reviewMAP Pharmaceuticals, Inc. (Biotech Organization focused on inhaled devices) (2008 2011)Clinical Project LeadParticipated in protocol writing, CRF designing, study related documents development, report writing for IND, NDA submission, and final reportManaged study specific vendorsProfessional Experience continuedManaged the conduct of assigned clinical investigations and activities associated with clinical trialsManaged the interaction of appropriate departments and staff to support and maintain the clinical investigations in drug safetyAssisted with preparation of department budgets, timelines, and project plans for drug safetyNegotiated contracts and budget for drug safetyWorked in the DMC board, actively participating in AE, SAE, initial reporting, follow-up, narrative writing, and resolutionWorked with the Medical Monitor for the patient safety reviewEducational BackgroundMD, Medical Surgery Rangpur Medical College, Rangpur, BangladeshHigher Secondary School Certificate Mymensingh Girls Cadet College, Mymensingh, BangladeshLicensure and CertificationsFundamentals of Project Management Barnett InternationalTherapeutic ExperienceCardiologyDermatologyDeviceEndocrinology/MetabolismoDiabetesoMigrainesOncologyoBreastoGastrointestinal (GI)/ Genitourinary (GU)OphthalmologyOther Clinical Trial ExperiencePhase I and II trials evaluating Breast Cancer, Solid Tumor, and other CancersPhase II and III trials evaluating Gastric Cancer and Renal CancerPhase I, II, and II trials evaluating migraines and devicesPhase II and III trials evaluating Diabetes Mellitus/EndocrinePhase II and III trials evaluating OphthalmologyPhase II and III trials evaluating skin diseasePhase II and III trials evaluating cardiovascular disease.Covid vaccineKidney TransplantGeneral AnxietyLanguagesEnglish, Bengali |
