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Summary

An analytically driven, seasoned professional with a comprehensive understanding of the pharmaceutical industry with extensive experience in operations which has led to proven ability to effectively deliver critical projects | conducting/implementing risk-based gap assessments | audit plans | conduct & facilitating internal audits | management of back room & host external audits | assess and develop standard operating processes | oversee GxP Quality Management and training systems |  oversee/manage quality events/deviations including investigations & root cause analysis, robust CAPA development/implementation/effectiveness checks | facilitate inspection readiness with study teams, PV staff and cross functional areas including pre-staging and story boards | partner with Quality Assurance/Corporate Compliance/Auditing Services/Deloitte/Legal to ensure appropriate audit scope/SME availability/system & vendor support. Highly adaptable and dedicated to continuous process improvement and have a proven global track record with FDA/EMA/MHRA/HPRA external audits with no major or critical findings. Excellent communication, organizational, time management skills. Solid knowledge of Veeva quality document system, regulations, good documentation practices, data integrity/ALCOA, inspection readiness. Strong believer in teamwork and global cross-functional working.  

Work experience

Indivior Inc.
20192024

Head, Global Clinical, Medical and Safety Compliance

  • Role expanded to include leading the Global Clinical, Medical, and Safety Compliance division at Indivior Inc., ensuring adherence to international regulatory standards across functions. Expansion including taking over PV operation responsibilities for Aggregate reporting | management and tracking of Safety Data Exchange Agreements (SDEA) and Safety Managment Plans (SMP), Market Research, Investigator Initiated studies, Non-Interventional Studies | Project intake | maintenance and updating of Pharmacovigilance System Master File (PSMF)
  • In July 2020, when Indivior signed a Corporate Integrity Agreement, responsibility to oversee all obligations for all of R&D, PV and Medical was added. Collaborated with Corporate Compliance to complete Risk and Mitigation Plan | Created implementation procedures and created/updated processes to cover all requirements | developed and maintained a Compliance Journey Plan over the 5-year period
  • Developed and implemented comprehensive compliance strategies, enhancing the company's global operational integrity.
  • Collaborated with cross-functional teams to maintain high standards of clinical and medical safety across all projects.
  • Spearheaded initiatives to improve compliance processes, resulting in a 20% increase in efficiency while reducing training burdens.
  • Conducted thorough audits and risk assessments, identifying areas for improvement and mitigating potential compliance risks.
  • Provided expert guidance, training and mentoring to staff on compliance matters, fostering a culture of accountability and excellence.
  • Maintained up-to-date knowledge of industry regulations, ensuring the company remained at the forefront of compliance standards.
  • Successfully navigated complex regulatory environments, contributing to the company's reputation as a leader in clinical and medical safety compliance.
Indivior Inc.
20142019

Sr Manager of Clinical Compliance

  • Led the Clinical Compliance team at Indivior Inc., ensuring adherence to regulatory standards and industry best practices.
  • Developed and implemented compliance strategies that enhanced the company's regulatory standing and operational efficiency.
  • Implemented electronic TMF process following the DIA reference model and a central data management repository.
  • Spearheaded documentation reviews/investigations and inspection readiness for new product approvals including creating and updating processes | documenting/implementing/completing deviations/root cause analysis/CAPAs throughout product development | training/coaching/mentoring staff | escalating issues to senior management | tracking risk & mitigation plans through to completion | collaborating globally & cross-functionally | initiating strong strategic planning | creating story boards | reviewing TMFs and regulatory documentation including INDs/aggregate reports/consents/Investigator brochures | Sponsor oversight of CRO activities | conducted mock inspection interviews | ensured all BIMO guide topics were prepared for.   
  • Conducted comprehensive compliance audits and risk assessments, identifying areas for improvement and implementing corrective actions.
  • Provided expert guidance and training to staff on compliance protocols, fostering a culture of compliance awareness and accountability for FDA/MHRA/EEA/HPRA/ICH GCP and GVP requirements.
  • Successfully managed relationships with regulatory bodies, ensuring timely and accurate reporting of compliance activities.
  • Maintained up-to-date knowledge of industry regulations and trends, ensuring the company remained at the forefront of compliance standards.
  • Achieved product approval with only one minor audit observation and FDA waived another product approval audit due to those results.
Indivior Inc.
20122014

Pharmacovigilance (PV) Compliance Specialist

  • Served as a Pharmacovigilance Compliance Specialist at Indivior Inc., ensuring adherence to regulatory requirements and industry standards. Created/updated processes to meet GvP standards | created a formal follow-up process for adverse event reporting | collected safety reports/drafted summaries | conducted literature reviews | created root cause analysis and completed CAPA for MHRA findings | participated in MHRA PV follow-up audits | assisted with set up with new PV vendor and Argus system transfer | completed safety reconciliations.
  • Monitored and evaluated drug safety data, contributing to the maintenance of high safety standards for pharmaceutical products.
  • Conducted thorough investigations and inspections to identify compliance gaps and recommended corrective actions.
  • Developed and delivered training programs to enhance team understanding of pharmacovigilance regulations and best practices.
  • Collaborated with regulatory authorities to ensure timely and accurate reporting of adverse events.
  • Maintained comprehensive documentation and records to support compliance efforts and facilitate audits.
  • Utilized strong analytical skills to assess risk and develop mitigation strategies, enhancing overall product safety.
  • Awarded for completion of urgent MHRA gap related to PV Risk Management Plan and aggregate reports that was company critical. 
Virginia Commonwealth University (VCU)
20102012

Director, VCU Clinical Trials Office

  • Started a newly created centralized VCU Clinical Trials Office at VCU, overseeing all aspects of clinical trial operations, budgeting, contracting, IRB submissions and safety reporting.
  • Managed a large diverse team of professionals, including a coordinator pool, ensuring efficient coordination and execution of clinical trials.
  • Developed and implemented strategic plans to enhance the effectiveness and reach of clinical research initiatives.
  • Fostered collaborations with academic and industry partners, expanding the scope and impact of clinical trials.
  • Ensured compliance with regulatory standards and ethical guidelines, maintaining the integrity of research activities.
  • Streamlined processes to improve the efficiency of trial management, reducing operational costs by 15% and increasing awards by 75%.
  • Provided leadership in the development of innovative research methodologies and practices.
  • Promoted a culture of excellence and continuous improvement within the Clinical Trials Office.
  • Became a preferred site for several Pharmaceutical companies. Coordinated assignment of Principal Investigators and performed all start up activities to expedite time to first patient enrolled.
Virginia Commonwealth University (VCU)
20032010

Director, VCU Pediatric Clinical Trials Office

  • Led the VCU Pediatric Clinical Trials Office at Virginia Commonwealth University, overseeing all aspects of clinical trial operations with primary focus of implementation of the FDA / ICH Pediatric Rule requirement for pediatric clinical trials.
  • Managed a multidisciplinary team to ensure the successful execution and completion of pediatric clinical trials. Grew from 2 Principal Investigators in 2 departments with 6 clinical trials to having clinical trials is all Pediatric departments with 116 open clinical trials.
  • Developed and implemented strategic plans to enhance the efficiency and effectiveness of clinical trial processes including creation of a centralized coordinator pool to support physicians.
  • Collaborated with researchers and healthcare professionals to design and conduct innovative pediatric clinical studies. Managed awarded Investigator Initiated oncology studies and grants to fulfill all Sponsor and Site regulatory responsibilities.
  • Ensured compliance with regulatory requirements and ethical standards, maintaining the highest level of integrity in clinical research.
  • Secured funding and resources necessary for the advancement of pediatric clinical trials, contributing to significant research breakthroughs.
  • Fostered partnerships with external organizations and stakeholders to expand research opportunities and collaborations.
  • Promoted a culture of excellence and continuous improvement within the clinical trials office, enhancing overall research outcomes.
  • Acknowledged as Top Recruiting Site for 8 clinical trials
  • Participated as site representative for numerous Sponsor/FDA audits successfully without major or critical findings.
Virginia Commonwealth University (VCU)
20012003

Project Manager I CRA Sickle Cell Disease (SCD) Research

  • Led and managed the Sickle Cell Disease Research program at VCU for NIH research grant and Industry sponsored Phase I-IV research, ensuring timely and successful completion of all project milestones.
  • Coordinated cross-functional teams to facilitate seamless collaboration and communication throughout the research process.
  • Developed and implemented project plans, timelines, and budgets, ensuring adherence to research objectives and financial constraints.
  • Completed site selection/start-up activities | training/coaching/mentoring | developed a scannable pain scale for SCD and validated | SAE reporting and reconciliation | IRB | oversaw all coordinator activities for Industry sponsored clinical trials.
  • Monitored project progress and performance, identifying potential risks and implementing corrective actions to maintain project trajectory.
  • Fostered strong relationships with stakeholders, including researchers, sponsors, and participants, to enhance project support and engagement.
  • Conducted data analysis and prepared comprehensive reports to communicate research findings to stakeholders and funding bodies.
  • Ensured compliance with ethical standards and regulatory requirements, maintaining the integrity and credibility of the research.
  • Promoted a culture of continuous improvement and innovation within the research team, contributing to the advancement of sickle cell disease knowledge and treatment.
Virginia Commonwealth University (VCU)
19982001

Clinical Research Coordinator, Department of Neurology

  • Coordinated Phase I - IV clinical trials within the Department of Neurology at VCU, ensuring compliance with all regulatory requirements including feasibility | study/site set-up | IRB | strategic planning | recruitment | data management | budget/contracting | monitoring | Safety adverse event reporting | Regulatory binder/Case report form completion | monitoring/auditing visits | study closeout.
  • Acknowledged as Top Recruiting Site for 3 clinical trials with a 25% increase in participant retention rates.
  • Developed and maintained detailed documentation of clinical trials, contributing to the accuracy and reliability of research data. 
  • Collaborated with multidisciplinary teams to facilitate smooth execution of research protocols and enhance study outcomes.
  • Implemented effective data management strategies, improving data collection efficiency by 20%.
  • Conducted regular training sessions for research staff, promoting adherence to best practices and ethical standards.
  • Liaised with external partners and sponsors, fostering strong relationships and securing additional funding for research initiatives.
  • Ensured all research activities were conducted in accordance with institutional guidelines and ethical standards, maintaining the integrity of the research process.
  • Participated as site representative for numerous Sponsor/FDA audits successfully without major or critical findings.