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Experiences

Current Experience

  • Clinical Research Manager


    Since October 2013
    currently managing team of 8 direct reports (7 cras and 1 cta) and 1 dotted line report (project Coordinator). key accountabilities on the current role: • provide Leadership to nn bulgaria clinical staff, motivate, Coach and develop all direct reports • ensure agreed number of patients are recruited within defined timeframe • secure all agreed milestones in the trials are kept • ensure clinical Quality Management System deliverables are met as requested • ensure timely and good quality data in CTMS and other required systems • responsible for Compliance to requirements within clinical area • build partnership/relationship with sites staff (doctors and nurses) • closely cooperate with internal stakeholders (studies team members, regulatory, medical, Marketing, Sales) • identify possible drawbacks in the study progress in the Planning and execution phases and proposes solutions to overcome them • set the goals and responsibilities for an individual clinical operational staff and follow-up on realization • plan, execute and supervise budget and resources • review and sign the installments prepared by the CRA/ltm for the payments to investigators/site staff, Hospitals and external vendors according to each contract`s provisions • Clinical Trial application responsible Currently managing team of 8 direct reports (7 CRAs and 1 CTA) and 1 dotted line report (Project coordinator). Key accountabilities on the current role: • Provide leadership to NN Bulgaria clinical staff, motivate, coach and develop all direct reports • Ensure agreed number of patients are recruited within defined timeframe • Secure all agreed milestones in the trials are kept • Ensure clinical quality management system deliverables are met as requested • Ensure timely and good quality data in CTMS and other required systems • Responsible for compliance to requirements within Clinical area • Build partnership/relationship with Sites Staff (doctors and nurses) • Closely cooperate with internal stakeholders (Studies team members, Regulatory, Medical, Marketing, Sales) • Identify possible drawbacks in the study progress in the planning and execution phases and proposes solutions to overcome them • Set the goals and responsibilities for an individual clinical operational staff and follow-up on realization • Plan, execute and supervise budget and resources • Review and sign the installments prepared by the CRA/LTM for the payments to Investigators/site staff, hospitals and external vendors according to each contract`s provisions • Clinical Trial Application responsible

Past Experience

  • Local/Regional Trial Manager

    May 2011 --- October 2013
    responsible for coordinating tasks and Communication between the clinical Project Manager (cpm) or international trial manager (itm) at hq and local trial managers (ltms) in order to facilitate progress and global coordination of the Clinical Trial programme as described in the Clinical Development plan. team Leader for all the ltms working within the clinical programme in the respective region as well as project partners in other functions and affiliates, drawing on deep knowledge and extensive experience about operational trial management. regional responsible dealing with as many issues as possible prior to escalating to the itms. managed countries mainly within europe. the rtm main responsibilities include: • represent Clinical operations from the region in the international study group (isg) - coordinate input to the isg from all involved within the region (ltms/cras/medical etc.) - communicate decisions from the isg to all involved within the region • main contact for Communication of trial issues between region and itm/cpm • ensure timely and accurate Communication, and function as key point of contact for itm and ltms • overall trial organisation and coordination within region • prepare the regional Patient Recruitment Strategy, monitor recruitment within the region closely, and take appropriate actions if timelines or recruitment targets are at risk • consolidate country strategies per region and ensure that the ltm consolidates the site strategies • consolidate science)" rel="nofollow">Protocol/amendment input per region • provide consolidated regional input for review of key documents • consolidate crf/diary, systems and vendor input per region • follow-up/Communication regarding ec/ha approvals • provide trial status updates/reports/feedback to itm/cpm as required • support local organisation in case of audits/inspections • regional Training as applicable • ensure and encourage share better practice regionally

  • Local Trial Manager/Clinical Research Associate

    June 2010 --- July 2011
    • conducts trials in accordance with protocols, SOP’s, local regulations and ich gcp guidelines, including feasibility, sites selections, preparing and submitting cta to relevant ec(s), obtaining necessary approvals and Documentation, site initiations, monitoring and sdv, management of site recruitment performance, trial supplies management, Data cleaning activities, close-out and archiving. • meets all local and company requirements with respect to safety reporting in trials. • closely cooperates with Project Management, Data Management and hq throughout the trial to ensure milestones are achieved. • maintains current knowledge of Therapeutic Areas, SOP’s, local regulations, ich gcp guidelines and other external requirements. • Planning and conducting trials in accordance with science)" rel="nofollow">Protocol, nn SOP’s, local procedures, national regulations/ requirements and ich gcp. • assuring the quality of trial data • cross organisational collaboration throughout the trial. • study budget management at a country level. • coordinating /performing all monitoring activities from study start up (initiation) until the study close out. • assuring the quality of trial data • educating / updating site staff in trial conduct and ensure update of gcp • assuring the quality of relations with customers and site staff • manage Patient Recruitment strategies on country level

  • Clinical Research Associate (CRA)

    September 2008 --- January 2011
    • responsible for taking Leadership of site management for the selection and initiation of sites • conduction and closing activities of the appointed studies in Compliance with local regulations, ich gcp, nn procedures and science)" rel="nofollow">Protocol requirements to ensure data quality and study subject protection. • responsible for recruitment at site level. • efficient and accurate site feasibility visits incl. Analysis of site Logistics, site personnel performance/quality indicators and accountability for Patient Recruitment strategies • meet all local and company requirement with respect to safety reporting • collaborate with Data Management/Logistics in resolving queries • manage trial product requirements, temperature deviations and Training of site staff • motivate and build strong relations with site personnel to ensure nn is their preferred provider • ensure collaboration with and deliveries from vendors locally • collection and management of essential documents • participation at investigators meetings to ensure relations with sites as well as active presentation • timeliness in deliveries through process Planning and goal setting • identify potential risks and proactively take action to prevent or mitigate • therapeutic knowledge and demonstrated understanding of diseases and treatments • maintain knowledge of and act in Compliance with global and local sops, gcp and other regulatory requirements • support audit and inspections at sites • proficient use of nn systems

  • Medical Sales Representative

    January 2006 --- September 2008
    • responsible for Selling and promoting products in the territory to secure Sales goals are reached • seek out new customers: evaluate their potential • satisfies existing or created customer needs • plan and implement activities in own territory and participate in local events – conferences, humanitarian events, congresses whenever beneficial. • update product and market knowledge to ensure the highest standard of Sales representation • monitor and report on competitors activities • responsible for appropriate control of expenses and for adhering to the expense budget as agreed

Knowledge

LinkedIn Assessment :
TeamworkResults FocusedProactivityICH-GCPClinical trialsClinical DevelopmentEDCClinical researchClinical trial managementPharmacovigilanceClinical monitoringBudgetingDiabetesEndocrinologyRegulatory submissionsSOPProject ManagementHemophiliaHemostasisCRODrug DevelopmentHematologyGLPTrial ManagementType 2 DiabetesPharmaceutical salesPatient recruitmentPharmaceutical IndustryPharmaceuticsSOPGCPBudgetsoncologyInformClinical Data ManagementCTMSDrug SafetypharmacologyCardiologyresult orientedRegulatory RequirementsRegulatory affairsClinical pharmacologyTherapeutic AreasProtocolBiopharmaceuticalsData ManagementOracle ClinicalClinical operationsPharmaceutical Research

Education

  • Master in Faculty of pharmacy from Medical University - Sofia, Faculty of pharmacy in 2006

Area / Region

Sofia, Bulgaria

Others

Driving License
  • No

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