Summary
Overview
Work History
Education
Skills
Professional Development
Therapeutic Experience
Publications
Timeline
Generic

Shari Roberts

Waterdown,ON

Summary

Pharmaceutical professional prepared for advanced pharmacovigilance roles, bringing wealth of expertise in adverse event reporting and regulatory submissions. Proven record of improving pharmacovigilance systems and enhancing drug safety profiles. Highly focused on team collaboration and achieving impactful results, with reliability and adaptability to changing needs. Skilled in risk assessment, safety signal detection, and regulatory compliance, with valued analytical mindset. Ready to bring a wealth of experience and a fresh perspective to Everest Clinical Research.

Overview

22
22
years of professional experience

Work History

CLINICAL DATA MANAGER III

ALLUCENT
04.2021 - 01.2025
  • Led and facilitated communication between internal and external stakeholders in data management.
  • Oversaw budget tracking, forecasts, and scope adjustments.
  • Developed, reviewed, and maintained key data management documents, including DMPs, eCRF specifications, DVPs, and external data transfer agreements.
  • Conducted user acceptance testing (UAT) to validate database integrity prior to deployment.
  • Managed data queries, validation checks, and discrepancy resolutions.
  • Ensured timely delivery of high-quality reports by monitoring key performance indicators.
  • Oversaw data collection, cleaning, coding, and reporting for audits and sponsor deliverables.
  • Managed database maintenance, locking procedures, and Trial Master File (TMF) close-out.

CLINICAL DATA MANAGER

BIOPHARMA SERVICES
09.2020 - 04.2021
  • Directed study processes from Data Management Plan (DMP) development to data lock and export.
  • Designed database forms and reviewed eCRFs based on study protocols.
  • Developed and executed user acceptance testing for electronic data edit checks in web-based forms.
  • Conducted data reviews and resolved inconsistencies prior to QA approval.
  • Provided guidance to junior data management professionals.
  • Optimized database structures for efficient data storage, retrieval, and analysis capabilities.
  • Provided training and mentorship to junior staff members, fostering professional growth and skills development.

DRUG SAFETY SPECIALIST

GLAXOSMITHKLINE
02.2007 - 05.2019
  • Assessed and triaged adverse events for processing, evaluating product complaints and cases of Unusual Lack of Efficacy, followed by necessary follow-ups.
  • Managed the reporting of safety cases for SAEs and ULOEs, ensuring precision, timely submission, and full compliance with regulatory requirements while upholding data integrity.
  • Conducted quality reviews and compliance audits, implementing corrective actions to support regulatory adherence.
  • Generated queries for critical or missing information, coordinating with Medical Information, external vendors, or directly contacting study sites via Data Clarification Forms (DCFs) to resolve discrepancies.
  • Performed quality control reviews of safety database entries from other pharmacovigilance personnel, ensuring case data aligned with source documents.
  • Served as the primary liaison with Health Canada, overseeing regulatory updates and initiatives such as electronic regulatory reporting (E2B) to maintain compliance.
  • Reviewed clinical trial documentation to identify relevant assets and ensure appropriate product licenses were integrated into the safety database. Conducted similar reviews for trial amendments and examined protocols for guidance on monitoring adverse events of special interest.
  • Contributed to the preparation and review of regulatory reporting documents, including DSURs/Annual Reports, Line Listings, and other required materials.
  • Managed Safety Data Exchange Agreements (SDEA), ensuring service providers fulfilled pharmacovigilance obligations and maintained seamless adverse event reporting. Conducted reconciliations per contract requirements and collaborated with Regulatory Affairs on end-of-year compliance reviews to identify deviations.
  • Facilitated smooth patient transitions from Special Access Programs (SAP) to Patient Support Programs (PSP), preventing drug interruptions and collaborating with stakeholders to ensure continuity of care.
  • Addressed urgent patient safety concerns, including expedited drug supply for a pediatric patient and vaccine recall management, ensuring timely intervention and patient well-being.
  • Led training courses for employees at all levels.

CLINICAL DATA MANAGER

AAI PHARMA INC.
01.2003 - 01.2007
  • Developed Safety Management Plans (SMPs) and protocol-specific validation strategies.
  • Designed and tested clinical study databases and validated programmed checks.
  • Led project teams to ensure quality data and timely deliverables, plus ensured that the forecasted hours were in line with the budget.
  • Oversaw data management processes from study startup through database lock including medical review and reconciliation of clinical SAEs to safety database.
  • Liaised with external vendors for seamless integration of third-party applications into existing workflows.

Education

Master of Science - CLINICAL BIOCHEMISTRY

University of Toronto
Toronto, ON

Bachelor of Science - APPLIED BIOCHEMISTRY WITH EMPHASIS IN BIOMEDICAL SCIENCE

University of Guelph
Guelph, ON

Skills

  • Effective collaboration and teamwork
  • Customer-focused approach
  • Attention to detail and analytical thinking
  • Problem-solving and critical thinking
  • Clear and efficient communication
  • Patient Safety Issues
  • Multitasking abilities and organizational skills
  • Vendor Management
  • Proficient in Argus
  • Service level agreements

Professional Development

  • Global safety database Argus Safety – Local Affiliate Module (LAM) component
  • Medidata Rave and Zelta Clinical Databases
  • SharePoint and BOX Content Management Software
  • Oracle Clinical Safety Database

Therapeutic Experience

  • Contributed to studies focusing on the following indications and therapies:

    • Hematology, specifically:
    o Phase II in Breast Cancer
    o Phase II in Colorectal Cancer
    o Phase III in Cold Agglutinin Disease (CAD)
    o Phase III (2 Studies) in Antibody Autoimmune Hemolytic Anemia (wAIHA)

    • Urology
    o Phase IV Erectile Dysfunction
    o Phase III Incontinence

    • Infectious Disease, specifically:
    o Phase I for Clostridium Difficile Infection (CDI)
    o Phase II for Clostridium Difficile Infection (CDI)
    o Phase II for Diarrhea
    o Phase I b adenovirus-vector based oral norovirus vaccine for Norovirus infection
    o Observational Study with different vaccines for SARS-CoV-2 infection

Publications

Shari Morley (1998). Masters of Science Thesis: Role of Protein Kinases in Stretch-induced Regulation of Elastin Synthesis Through Increased Translational Efficiency

Timeline

CLINICAL DATA MANAGER III

ALLUCENT
04.2021 - 01.2025

CLINICAL DATA MANAGER

BIOPHARMA SERVICES
09.2020 - 04.2021

DRUG SAFETY SPECIALIST

GLAXOSMITHKLINE
02.2007 - 05.2019

CLINICAL DATA MANAGER

AAI PHARMA INC.
01.2003 - 01.2007

Master of Science - CLINICAL BIOCHEMISTRY

University of Toronto

Bachelor of Science - APPLIED BIOCHEMISTRY WITH EMPHASIS IN BIOMEDICAL SCIENCE

University of Guelph

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