Barbara Keskiner

Experience

• 

  Omnicom Media Group

  Jan 2000 - Jan 2002

  Account Executive
• 

  Clinical Research of West Florida, Inc

  Oct 2002 - now

  ▶ SCOPE: Manage 130 active clinical trials annually and start-up procedures for 50+ studies, facilitating quality and compliance with SOPs, protocols, and GCP requirements. Ensure swift completion of SOPs, leveraging expertise at managing studies at various stages simultaneously. Hire, train, and communicate with staff, physicians, vendors, and sponsors regarding study conduct, monitoring, and management from feasibility and start up to study execution. Oversee teams across clinical, regulatory, marketing, data management, laboratory, and administrative functions. ▶ KEY CONTRIBUTIONS:● Communicate clinical trial needs and present to site clients, maximizing conversions and awards for sites. Ensure site requirements match study needs for smooth execution.● Foster a culture of continuous improvement to ensure optimal performance and study execution. Maintain currency with industry and market trends, ensuring best practices. ● Deliver quality and efficiency across all site operations with acute attention to detail for data entry, ensuring zero findings from two FDA audits.● Partner with site and patient engagement team, CROs, and vendors to advance recruitment and retention strategies. Deliver consistent track record of quality patient experiences on site. ● Manage protocol and vendors for 34 studies simultaneously. ● Expertise in all aspects of conducting clinical trial protocol including patient recruitment, screening, and enrollment, clinical site visit coordination, phlebotomy, ECGs, vitals, joint counts, drug administration, etc.● Foster a culture of continuous improvement to ensure optimal performance and study execution. Maintain currency with industry and market trends, ensuring best practices. Automated documentation methods from paper to electronic format.● Ensure accuracy and quality data utilizing RealTime CTMS. Updated CRO site databases with expertise in various therapeutic areas and CRWF capabilities to increase capability for future studies. Show less ▶ SCOPE: Oversee strategic business development and growth, securing high-value opportunities, ensuring robust sales pipeline, and managing a dynamic portfolio of pharmaceutical and CRO partnerships. Achieve high award rates, deploying innovative techniques to identify opportunities and convert promising leads to secured awards. Outline protocol and regulatory guidance for clinical staff. Negotiate contracts and manage third-party vendors.▶ KEY CONTRIBUTIONS:● Delivered 75% award rate, identifying growth areas and securing 130 studies annually with successful completion of RFPs. Spearheaded study start-up procedures for 50+ studies annually. Leverage rolodex of industry contacts.● Proactively scout and engage with key stakeholders in pharmaceutical companies and CROs via networking at industry conferences and personal rolodex of leading contacts. Integrate innovative methods and resources to identify growth areas and secure prospects, ensuring consistent flow of opportunities.● Deliver clear communication with knowledge of all aspects of clinical trial management and disease states. Synthesize complex, technical information to easily understood terms, interfacing with medical personnel (doctors and nurses), site clients, patients, and internal staff. Show less ▶ SCOPE: Oversaw daily operations for site, study logistics, project management, and financial metrics including budget targets, reports, and regulatory compliance, reporting directly to President/CEO. Ensured continuity across all multitherapeutic study areas (Phases I-IV). Integrated business processes and coordinated with clinical team. Oversaw cross-functional leadership of Lab, EDC, and Marketing.▶ KEY CONTRIBUTIONS:● Managed up to 40 concurrent studies while tracking progress and completion, ensuring regulatory compliance, meeting study requirements, and delivering reliable, high-quality data.● Ensured site compliance with SOPs and FDA/GCP guidelines. ● Outlined hiring process and set initiatives to increase staff density, establish good practices/standards, and ensure retention as business grew. Coached and mentored staff across disciplines/practice areas.● Improved processes and initiated culture of continuous improvement to better position site for repeated business and outstanding industry reputation. Ensured quality data delivery and study execution. Show less

  • Director of Clinical Operations

    Jan 2019 - now

  • Director of Business Development

    Jan 2018 - now

  • Site Director

    Oct 2014 - Dec 2019

  • Regulatory Affairs Leader

    Oct 2002 - Oct 2014