Dawn Sayre RN, MS

• Collaborated with Otsuka key stakeholders to establish priorities and allocate resources effectively, optimizing the overall study timeline.
• Presented updates on study progress to senior leadership, highlighting key milestones and challenges encountered.
• CRA/Monitoring oversight for all clinical trial.
• Assist in selection of preferred laboratory vendors, providing insight into unique needs of different study phases.
• Contributes to the review, analysis, and interpretation of data, including development of clinical study reports.
• Supports program and study level inspection-readiness activities and ensures teams are inspection ready.
• Supervise those who are working on the trial.
• Assist in implementation of innovative technology including eSource, eConsent, and patient engagement applications.
• Work with internal and external stakeholders across a matrix organization to assure all team members are aware of study activities and milestones to achieve DBL and CSR is complete and on time and with a budget.
• Improved clinical trial efficiency by streamlining processes and implementing quality control measures.
• Facilitated seamless transitions between different phases or arms of clinical studies through meticulous planning.
• Developed detailed study protocols for successful clinical trials, ensuring accurate data collection and analysis.
• Coordinated with regulatory agencies on submission requirements and timelines, expediting approvals as needed for continued study progression.
• Continually assessed emerging trends in the field of clinical research management to inform future strategy decisions.
• Negotiated contracts with vendors and service providers, securing competitive pricing while maintaining high-quality standards for all aspects of the study.
• Championed patient safety by implementing rigorous monitoring procedures and promptly addressing any concerns or adverse events.
• Mentored junior team members in best practices for managing clinical trials effectively.
• Ensured regulatory compliance by maintaining thorough documentation and adhering to industry standards throughout the study lifecycle.
• Managed cross-functional teams to ensure timely completion of clinical studies, resulting in expedited drug approval processes.
• Monitored study progress closely, identifying potential risks and proactively addressing issues to maintain project timelines.
• Maintained open communication channels with all team members, fostering a positive work environment conducive to achieving shared goals.
• Implemented innovative strategies to recruit and retain diverse patient populations for complex clinical trials, improving study outcomes and validity.
• Conducted regular site visits to oversee trial operations firsthand, ensuring proper execution of protocols at all locations involved in the study.
• Created comprehensive training materials for staff members, enhancing their understanding of protocol requirements and increasing adherence rates.
• Utilized cutting-edge technology platforms to manage data efficiently, leading to more accurate results and faster decision-making processes.
• Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
• Followed informed consent processes and maintained records.
• Gathered, processed, and shipped lab specimens.
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Maintained compliance with protocols covering patient care and clinical trial operations.
• Complied with research protocols by providing ongoing quality control audits.
• Collected, evaluated, and modeled collected data.
• Reviewed referral information and kept track of intakes from various referral sources.
• Facilitated focus group sessions with project patients.
• Monitored unit budget to meet financial objectives for spend rate and funding.

Key Projects/Achievements:

Clinical operational lead for multiple phase clinical studies, providing leadership to internal teams, CROs, and external service providers. Studies conducted included CNS particularly for mental health (Bipolar, Schizophrenia, Depression, ADHD, epilepsy) Assures strategy alignment and consistency across program and vendors. Served as an operational lead for registrational study to support approval of Abilify Asimtufii (approved April 2023). Clinical lead in a FDA audit for Abilify approval in January 2024 with no findings

Indications: Nephrology, Central Nervous System -CNS (ADHD, Depression, Bipolar, Schizophrenia, epilepsy) Translational Medicine

• Managed vendor relationships and negotiated contracts, ensuring timely delivery of high-quality services while maintaining cost control.
• Oversaw site selection and initiated partnerships with qualified investigators, leading to optimized resource utilization and accelerated study start-up times.
• Evaluated performance metrics against established benchmarks, identifying opportunities for improvement and implementing appropriate action plans.
• Ensured compliance with regulatory requirements by conducting regular audits and implementing corrective actions as needed.
• Responsible for the development of a comprehensive project plan that is designed to establish project milestones and establish communication processes.
• Developed study materials (e.g., protocol amendments, CRFs, study manual, training materials, etc.) to support protocol and regulatory compliance.
• Identified risks and implemented contingencies as needed.
• Enhanced patient recruitment and retention strategies, leading to increased enrollment numbers and reduced dropout rates.
• Coordinated the efforts of the Project Team, including Clinical Research Associates and Clinical, Data Management, Biostatistics, Medical Safety, Medical Writing, Study Supply functional units.
• Led efforts to optimize study site performance by implementing targeted monitoring strategies and providing ongoing support to site staff.
• Achieved study objectives by working with team members to set project priorities and milestones and resolve project conflicts; respond promptly and appropriately to study issues raised by investigative sites, sponsors, monitors and consultants; and participate in the analysis, summary and reporting of clinical data for regulatory or marketing purpose throughout the course of the study.
• Built strong relationships with key opinion leaders in therapeutic areas relevant to company''s product pipeline, leveraging their expertise to inform study design decisions.
• Tracked all studies activities and reports on the ongoing status of tasks to completion.
• Established effective communication channels among team members, fostering a collaborative environment conducive to successful project execution.
• Kept line management and Project Team informed on progress of the study/studies, new developments, or deviation of plans in such a way that pro-actively and timely can be anticipated on these developments.
• Led cross-functional teams to successfully complete complex clinical trials within budget and deadline constraints.
• Managed Clinical Research Associate and Clinical Research Organizations
• Devised strategic plans for the successful execution of multiple simultaneous clinical projects, achieving organizational objectives within specified timeframes.
• Rewrote the Human Subject Testing (HST) Global Policy.
• Provided training and education globally on HST ethics and compliance related topics.
• Mitigated all risks for each study by leading study Risk Assessment and Mitigation meetings.
• Developed and designed associated training program(s), strategy, and materials.
• Led initiatives that strengthen the corporate infrastructure and remove barriers to compliance with HST Global Quality Standard

Indications: Women’s health, urogynecology, incontinence, infection control, and respiratory

• Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
• Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
• Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
• Implemented electronic data capturing systems to adhere with clinical research guidelines.
• Operated as the main point of contact for the site during the study.
• Conducted Site Qualification Visits by informing the investigator about the study and the study drug while evaluating the investigator and the staff’s ability to conduct the study.
• Conducted Site Initiation Visits by verifying that all preparatory steps have been completed, determined that facilities at the site remain adequate for the study, and familiarized the entire study personnel with the protocol.
• Drove and executed monitoring plan and study timelines at assigned sites.
• Verified that the investigator and study staff remain adequate throughout the study.
• Verified that the study protocol, standard operating procedures, and applicable regulatory requirements are being followed correctly and according to Good Clinical Practice Guidelines.
• Determined whether AEs and SAEs are properly reported within the time periods required.
• Interpreted sponsor policies and regulatory authority requirements for the investigator and the other study site personnel.
• Checked the accuracy and completeness of the electronic CRF entries against the source documents.
• Devised strategies to deal with each problem detected, proposed these strategies to the study staff and assisted in the implementation of proposed solutions.

Indications: renal transplant, vaccinations, hemophilia, inflammatory, orthopedics, oncology, immunology, neuroscience, & women’s health

• Compared adverse event source documents against safety database screens for transcription and medical accuracy.
• Facilitated effective communication between clinical teams and pharmacovigilance staff for coordinated response efforts.
• Provided support during regulatory inspections, demonstrating a strong understanding of compliance requirements.
• Continuously monitored, directed, and tracked the flow of the local and global safety cases for all UCB drug products.
• Requested additional information and conducted follow-up of all cases.
• Maintained the maintenance of appropriate documentation of the progress of all cases.
• Assisted in the development and implementation of training materials, contributing to the ongoing education of fellow Drug Safety Associates.
• Participated in ongoing training programs, honing skills necessary for success in the field of pharmacovigilance.
• Contributed to the development of standard operating procedures, promoting consistency in drug safety practices.
• Collaborated with cross-functional teams to develop risk mitigation strategies for drug products.
• Determined the seriousness and expectedness of spontaneous cases and decided whether it is expedited to the FDA.
• Data entered SAEs and SUSARs and expedited the study cases to the FDA.
• Reviewed literature and publications regularly for adverse experiences, including reports of therapeutic failure or “lack of efficacy” to assess any significant changes in the product safety profile.
• Kept current on all-pertinent regulatory safety publications and requirements. Informed and educated staff.

• Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
• Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
• Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
• Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
• Verified that the investigator and study staff remained adequate throughout the study.
• Verified that the study protocol, standard operating procedures, and applicable regulatory requirements are being followed correctly and according to Good Clinical Practice Guidelines.
• Determined whether AEs and SAEs are properly reported within the time periods required.
• Interpreted sponsor policies and regulatory authority requirements for the investigator and the other study site personnel.
• Checked the accuracy and completeness of the electronic CRF entries against the source documents.
• Devised strategies to deal with each problem detected, proposed these strategies to the study staff and assisted in the implementation of proposed solutions.
• Participated in a Sponsor audit that adheres to Good Clinical Practice Guidelines.
• Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.

• Expedited study timelines by efficiently coordinating participant scheduling, follow-up appointments, and data entry tasks.
• Reduced protocol deviations by providing thorough training on study procedures to both staff members and participants alike.
• Developed research protocols in collaboration with multidisciplinary teams for streamlined study execution.
• Minimized risk of bias in study outcomes by rigorously adhering to randomization procedures during participant enrollment processes.
• Collected and documented adverse event information for evaluation by the investigator and reports to study sponsor in a timely manner.
• Placed eligible patients on both pharmaceutical and National Cancer Institute Phase I-IV clinical research studies. Wrote SAE reports in narrative form and sent the reports to the study sponsor and IRB within the time periods required.
• Educated patients, families, physicians, and ancillary about clinical research trials and investigational drug side effects.
• Worked with monitors at the following pharmaceutical companies: Schering Plough, Osiris, Johnson & Johnson, and Super Gen.
• Served as a resource to physicians concerning protocol requirements and determined data requirements as delineated by each clinical trial.
• Prepared and submitted research protocols to the Institutional Review Board, wrote informed consents, and maintained Institutional Review Board compliance within the research department.
• Screened cancer patients for protocol eligibility requirements
• Obtained informed consent through patient education.
• Familiar with FDA regulations, Standard Operating Procedures, and Good Clinical Practice guidelines.
• Maintained case report forms for each patient placed on study.
• Instructed patients and family regarding study design and purpose, anticipated side effects, patient’s responsibilities, and rights.
• Prepared budgets for each study