Daria Golubnichenko

Experience

• 

  Pfizer

  Sept 2005 - Jun 2007

  • Clinical Trial Administrator

    Jun 2006 - Jun 2007

  • Secretary

    Sept 2005 - May 2006
• 

  IQVIA

  Jun 2007 - Sept 2018

  As a Site Activation Manager at IQVIA, I was responsible for managing site activation activities for clinical trials. I collaborated with internal and external stakeholders to ensure the timely and efficient activation of sites, adhering to regulatory requirements and study protocols. I utilized my team player mindset and critical thinking skills to identify and address potential challenges, ensuring successful site activation. Additionally, I provided guidance and support to cross-functional teams, fostering effective collaboration and communication. Show less As a Country Site Identification Lead I managed country site identification process, supported project efforts through data mining of internal databases, reviewed of investigators for quality assurance and development of prioritize site list based on historic site performance and capability. Provided information such as disease prevalence, Company experience in various therapeutic areas, standard of care, availability / registration status /reimbursement statusetc. to relevant parties as necessary or upon request Reconciled and interpreted feasibility data. Extrapolated data collected to provide a country-level assessment. Provide accurate, robust and realistic recommendations for country site numbers, recruitment rates, timelines and screen failure rates.Liaised with internal and external customers to coordinate the collection and delivery of feasibility data.Distributed, tracked and negotiated the Confidential Disclosure Agreements (CDAs) with assistance from Management / Legal department as appropriate.Managed the investigator database entries and quality, ensuring complete investigator and site information is captured, monitor for duplicate entries.Tracked all communications with sites in Company Databases, ensured status of documents is updated in real time. Trained and supported junior team members as appropriate. Show less As a Site ID lead managed site identification team on projects and / or programs including the larger and more difficult trials.Managed the investigator database entry and quality, ensuring complete investigator and site information is captured, monitor for duplicate entries.Supported project efforts through data mining of internal databases, review of investigators for quality assurance and development of prioritized site list for assigned projects.Analyzed data to identify and tier best potential sites for recommendation to internal and external customer utilizing historic site performance metrics, cluster site information, protocol density, partner sites, and feasibility data.Overseen Cluster site identification and selection process.Helped to develop and maintain work processes, SOPs and work instructions.Supported the start-up process to ensure the rapid initiation of recommended sites.Distributed, tracked and negotiated the Confidential Disclosure Agreements (CDAs) and consults with Management / QLegal as needed.Provided project progress reports to management, Internal and External project teams.Adhered to project timelines and budgets.Initiated strategy call with Feasibility lead, Medical Scientific Services lead and Clinical Operations lead to review draft Site ID strategy for identifying best potential sites and processes to be followed.Attended proposal strategy calls and provides historic site data.Maintained and update departmental project files, including site list and other project materials as required.Identified and proactively share best practices and lessons learned across the team to drive successful site identification start-up. Show less As a CRA I was responsible for site Selection, Initiation, routine Monitoring and booster visits, Site CloseOut visits for assigned studies. Facilitated the recruitment of subjects for the trial. Ensured that potential subjects are properly informed about the trial and that informed consent is obtained in accordance with regulatory requirements.I was responsible for verification of the clinical trial data recorded by investigators that it's accurate and that the trial is being conducted in compliance with the protocol, Good Clinical Practice (GCP), and regulatory requirements.Assisted with Clinical Research investigator site trainings, ensured site staff complete the data entry and resolve queries within expected timelines. Show less

  • Site Activation Manager

    Apr 2018 - Sept 2018

  • Associate Regulatory and Start-Up Manager

    Dec 2016 - Mar 2018

  • Sr Site ID Services Specialist

    Jul 2013 - Nov 2016

  • Regulatory and Start Up Team Lead/ Site ID Country Lead

    Apr 2012 - Jun 2013

  • Associate Regulatory Start Up Team Lead/Site Identification Lead

    Dec 2010 - Mar 2012

  • Clinical Research Associate

    Apr 2008 - Dec 2010

  • Senior Clinical Trials assistant

    Jun 2007 - Apr 2008
• 

  Syneos Health

  Sept 2018 - now

  As a Senior Site Activation Manager , I'm responsible for providing an oversight of all project start-up deliverables which encompasses all activities from site selection through site activation ready and into the life cycle maintenance of projects. I ensure all project deliverables meet the internal and customers ’expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk identification, mitigation and start up project management.As a Site Activation Manager I develop and maintain relationships with customers in alignment with their assigned projects. I ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed. Show less As a Senior Start Up Project Delivery Manager at Syneos Health, I am responsible for managing and delivering start-up projects for clinical trials. I oversee the planning, site identification and site selection activities, regulatory submission process, site regulatory packages preparation and approval, IP release , ensuring compliance with regulatory requirements and project timelines. I utilize my analytical skills and creative problem-solving abilities to identify potential bottlenecks and develop strategies to mitigate them. Additionally, I collaborate with cross-functional teams to and act as Primary Point of Contact for the Client and ensure effective communication and coordination throughout the start-up process. Show less

  • Senior Site Activation Manager

    Apr 2023 - now

  • Sr. Project Delivery Manager

    Sept 2018 - Apr 2023