Abby Rufus
Houston,TX
Summary
Accomplished Global Clinical Operation Lead with a proven track record at Moderna, showcasing expertise in CTMS proficiency and cross-functional collaboration. Spearheaded clinical trial operations, enhancing data integrity and stakeholder relationships. Achieved significant milestones through strategic risk management and operational efficiency, demonstrating exceptional leadership and communication skills.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Global Clinical Operation Lead
Moderna
12.2021 - Current
- Trial Coordination & Oversight: Lead clinical trial operations and the study team by coordinating functional teamwork and activities across sites, CRAs, and stakeholders, ensuring that all study activities are aligned with regulatory requirements and project milestones.
- Allocate and optimize resources for project efficiency.
- Oversee clinical project delivery strategy, cost assumptions, and budgets for assigned projects.
- Enhanced vendor and client relationships through effective vendor delivery management and clinical deliverables related to endpoints.
- Influenced strategies to align with global goals.
- Performed regular reviews of CRAs metrics to identify site-specific trends and quality issues.
- Supervised the creation and maintenance of crucial study documents to ensure inspection readiness.
- Database Cleaning and Collaboration with Data Management: Works closely with Data Managers to conduct routine database cleaning, data cut-offs, interim and final database lock cleaning, ensuring data integrity, and identifying inconsistencies that require follow-ups.
- Risk Management: Conducts risk assessments and develops mitigation strategies, proactively addressing potential issues and ensuring seamless trial progression.
- Ensured project milestones were achieved through quality and risk management.
- Managed project expenses, scope, and schedule to ensure budget compliance.
- Developed and implemented operational strategies, policies, and procedures to ensure organizational efficiency.
Sr Clinical Trial Manager
ICON (FSP Pfizer)
09.2017 - 10.2021
- Trial Management: Performed oversight of pre-study site evaluations, site initiations, regulatory document collection and submission, interim monitoring, and study close-out visits in accordance with GCP, study-specific requirements, clinical monitoring plans, organizational SOPs, applicable regulatory requirements, and defined quality and performance standards.
- Budget Development and Monitoring: Created and managed clinical trial budgets, ensuring financial accuracy and transparency in alignment with project goals.
- Performed monthly analysis on the budget and hours billed by the clinical operations project team, and reviewed monthly invoices from investigative sites and vendors for approval and payment processes.
- Protocol Development, Planning, & Study Plan Development: Designed and implemented study start-up plans, monitoring strategies, and protocols, ensuring detailed guidelines for data capture and management.
- Cross-functional Collaboration: Worked closely with a cross-functional team to ensure clinical program timelines and goals are met.
- Served as the primary clinical contact, managing the execution of the protocol.
- Risk Management: Managed risk and contingencies proactively, and led problem-solving and resolution efforts.
- Ensured awareness of project-specific quality and performance standards, and provided timely responses to quality assurance regarding regulatory authority inspection audits.
- Strategic study timeline management: Effectively managed multiple projects and timelines simultaneously.
- Engaged problem-solving skills that ensured the meeting of critical timelines and improved the quality of deliverables.
- Responsible for communication and escalation of study-related issues as required, and provided support to CRAs, investigator sites, and vendors.
- Organized and managed clinical trials in compliance with ICH-GCP guidelines.
- Developed and implemented clinical trial management plans, protocols and reports.
Clinical Trial Manager
Simbec- Orion
07.2015 - 07.2017
- Led the planning and management of clinical studies from feasibility through closeout, in alignment with study timelines.
- Ensured operational feasibility, development of a realistic, detailed study start-up, country allocation, and site selection processes in collaboration with key stakeholders.
- Prepared the study and sites for audits and inspections, and coordinated responses to findings.
- Selected and managed study vendors in collaboration with the sourcing team.
- Managed study budgets and worked on investigator fees, site payments, and patient reimbursement activities.
- Identified and managed resource needs, monitored resource utilization, and established contingency plans as necessary.
- Performed a monthly analysis of the budget and hours billed by the clinical operations project team.
- Provided study support with vendor setup, management, and payment processes.
- Served as the primary clinical contact, managing the execution of the protocol.
- Responsible for communication and escalation of study-related issues as required, and provided support to CRAs, investigator sites, and vendors.
- Ensured awareness of project-specific quality and performance standards, and provided timely responses to quality assurance regarding regulatory authority inspection audits.
- Developed study management plans, and reviewed work instructions and SOPs as needed.
- Reviewed and approved routine monitoring visit reports and follow-up letters as per required timelines, utilizing CTMS and other applicable systems to review and provide study reports.
- Oversaw pre-study site evaluations, site initiations, and regulatory document collection.
- Prepared the study and sites for audits and inspections, and coordinated responses to findings.
- Generated and maintained high-quality study start-up and recruitment timelines, tracking progress effectively.
- Worked closely with a cross-functional team to ensure clinical program timelines and goals are met.
Clinical Research Associate I & II
Simbec Orion
01.2012 - 06.2015
- Performed CRF review, source data verification, drug accountability and compliance, document maintenance and archival
- Ensured Safety Reporting and compliance with adverse event reporting
- Ensured timely, accurate access and update of applicable trail management systems and trial master file documentation
- Ensured quality and integrity of data, and ensured sites were compliant with protocol, study requirements, GCP and applicable regulatory requirements
- Reviewed subjects’ safety data, AE/SAEs
- Ensured appropriate escalation, reporting and follow up on Adverse Events and Serious Adverse Event (SAE) according to protocol/regulatory requirements
- Verified CRF data accuracy, coordinating with Data Management to address discrepancies and resolve queries for clean, analyzable datasets
- Ensured delivery of all supplies and equipment to assigned study sites
- Coordinated activities of associates and investigators to ensure compliance with protocol and overall clinical objectives
- Performed pre-study visits, reviewing study-related information with potential investigators (study synopsis, study logistics)
- Provided necessary study updates to Clinical Management on a regular basis
- Performed study Interim Monitoring Visit and closeout visit activities ensuring that required documents are in order
- Drafted visit reports within 5 business days to ensure timely report finalization
- Established and maintained working relationship with study coordinators and investigators at assigned study sites
- Ensured accuracy and completeness of the data in CRFs and resolution of data queries
- Reported trends and observations noted at sites to study team
- Coordinated the timely delivery of trial materials, ensuring sites had the necessary resources to maintain protocol timelines and data collection standards
Clinical Research Coordinator
West Houston Clinical Service
08.2010 - 12.2011
- Implemented the subject recruitment strategy in conjunction with the Principal Investigator prior to startup.
- Compiled and submitted regulatory documents at study initiation promptly.
- Maintained compliance with all IRB guidelines for studies.
- Collected, organized, and submitted all required regulatory documents at study startup in a timely, accurate manner.
- Performed research assessment and patient intervention under the supervision of the Principal Investigator (PI).
- Assured compliance with all aspects of individual studies.
- Ensured the timely coordination and completion of study-related procedures within assigned responsibility.
- Ensured that all relevant regulatory and Good Clinical Practice (GCP) guidelines were adhered to.
- Recruited and screened potential study subjects according to the protocol’s inclusion and exclusion criteria.
- Compiled trial related documents into a master file as required by sponsor or regulatory agency.
Education
PhD - Public Health
Charisma University
01.2017
Master’s - Business Administration
University of Phoenix
01.2013
Bachelors of Science -
University of Ilorin
01.2009
Skills
- CTMS Proficiency
- Data Quality Assurance
- Trial Master File Management
- Trip Report Evaluation
- Vendor Management Expertise
- Risk Evaluation and Management
- Patient Recruitment Strategies
- Compliance and Inspection Preparedness
- Operational Strategy for Clinical Trials
- Cross-Functional Collaboration
- Employee Development
- IRT Systems Management
- Effective Communication
Clinicalresearchareas
- Oncology, Breast Cancer, Phase 2, Biological
- Oncology, Acute Multiple Leukemia, Phase 1/2, Pharmaceutical
- Oncology, Ovarian Cancer, Phase 3, Biological
- Oncology, Advanced Solid Tumors, Phase 1, Biological
- Oncology, Multiple Myeloma, Phase 1, Pharmaceutical
- Oncology, Non-Small Cell Lung Cancer, Phase 2, Biological
- Oncology, Advanced Colorectal Cancer, Phase 3, Pharmaceutical
- Cardiovascular, Myocardial Infarction, Phase 3, Pharmaceutical
- Cardiovascular, Pulmonary Hypertension, Phase 1, Pharmaceutical
- Cardiovascular, Aneurysm, Phase 1, Pharmaceutical
- Endocrinology, Diabetes Mellitus T2DM, Phase 3, Pharmaceutical
- Endocrinology, Diabetes Neuropathy, Phase 2, Pharmaceutical
- Infectious Disease, COVID-19, Phase 3, Vaccine, Pharmaceutical
- Infectious Disease, Hepatitis B, Phase 1, Vaccine, Pharmaceutical
- Infectious Disease, RSV, Phase 3, Biological
- CNS/Neurology, Bipolar Disorder, Phase 2, Pharmaceutical
- CNS/Neurology, Multiple Sclerosis, Phase 3, Biological
- CNS/Neurology, Alzheimer, Phase 2, Pharmaceutical
- CNS/Neurology, Chronic Pain, Phase 3, Pharmaceutical
- Rare Disease, DMD, Phase 1/2, Biological
- Rare Disease, Gaucher Disease, Phase 2, Pharmaceutical
Summary Of Experience
Abby Rufus is a seasoned Clinical Trial Operation Lead with over 14 years of experience in clinical research, leading Phase 1-3 trials across oncology, cardiology, infectious diseases, Neurology, Endocrinology and rare diseases. Expertise in trial management, regulatory compliance, and data integrity. Proactive and result oriented in project planning, initiations, evaluation, monitoring and closeouts. Abby has successfully overseen global studies at companies like Simbec Orion, ICON, Pfizer, and Moderna, ensuring inspection readiness and high-quality data that support regulatory submissions. Her strengths include study team management, strategic timeline management, study document authoring, CTMS/EDC/Trial Master File (TMF) management, cross functional collaboration, and budget oversight, with a proven ability to foster client and vendor relationships. Skilled in risk assessment, database cleaning, and cross-functional teamwork, Abby is committed to advancing medical research through effective trial execution and operational excellence.
Certification
- Project Management professional
Timeline
Global Clinical Operation Lead
Moderna
12.2021 - Current
Sr Clinical Trial Manager
ICON (FSP Pfizer)
09.2017 - 10.2021
Clinical Trial Manager
Simbec- Orion
07.2015 - 07.2017
Clinical Research Associate I & II
Simbec Orion
01.2012 - 06.2015
Clinical Research Coordinator
West Houston Clinical Service
08.2010 - 12.2011
- Project Management professional
PhD - Public Health
Charisma University
Master’s - Business Administration
University of Phoenix
Bachelors of Science -
University of Ilorin
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