Open To Work
Michele Bennett
Knightdale,North Carolina
Work Preference
Summary
Experienced Vendor Strategy Manager with extensive experience in BioPharma, specializing in vendor oversight, contract negotiation and supplier performance management within clinical research. Demonstrated success in risk mitigation and budget oversight, contributing to the successful execution of clinical trials. Proficient in developing RFPs, leading vendor selection, and cultivating long-term partnerships with third party vendors, including IVRS, EDC, and laboratory services. Results-driven professional with a focus on advancing vendor strategies to enhance operational efficiency and strengthen partnerships. Proven track record of driving organizational success through innovative solutions and effective collaboration. Committed to leveraging expertise to foster sustainable growth and improve vendor relations.
Overview
13
13
years of professional experience
Work History
Vendor Strategy Manager, FSP Pfizer
KPS Life
Knightdale, NC
12.2023 - 09.2025
- Oversaw timely vendor contracting with Clinical Operations, Procurement, Legal, and Finance
- Directed contract lifecycle management to ensure compliance and mitigate risks
- Collaborated with clinical and biomarker teams to align supplier capabilities with program needs, mitigating risk and resolving escalated performance issues
- Managed vendor performance issues, identifying risks and implementing corrective actions
- Facilitated vendor selection aligned with approved category strategy
- Served as primary liaison for vendors concerning service initiation and scope modifications.
- Monitored budget negotiations status and addressed escalation queries for sponsors
- Developed RFP templates to ensure consistency and compliance across submissions
- Guided clinical teams in accurate completion of RFPs within deadlines
- Provided oversight of contract & budget negotiations status and managed escalation queries on budgetary and contractual requests to sponsor decision-makers
Vendor Project Manager
ICON
Knightdale, NC
12.2021 - 09.2023
- Served as primary liaison for vendors, project teams, and clients throughout project lifecycle
- Directed third-party vendors with minimal supervision, ensuring alignment with project goals
- Facilitated weekly vendor management calls to address issues and promote collaboration
- Managed contractual deliverables, tracking progress against metrics and adherence to agreements
- Participated in bid defense processes as necessary to secure vendor partnerships
- Negotiated study contracts, overseeing vendor budgets and reporting to project management and clients
- Developed and maintained RFP templates to streamline vendor selection processes
- Oversaw multiple vendors from start-up through close-out, managing risks and resolving issues
- Conducted regular assessments of vendor performance to identify improvement areas.
- Managed day-to-day communications with multiple vendors simultaneously.
- Provided guidance on best practices for working with third-party vendors.
- Developed and implemented strategies for vendor onboarding, training, and performance management.
- Participated in and presented vendor management processes in project KOM (Kick-Off Meeting), and Investigator Meetings.
Clinical Trial Assistant
Zentalis
San Diego, California
10.2022 - 07.2023
- Ensured all study-related documentation was maintained in audit-ready condition
- Organized clinical operation SharePoint folders for easy document access
- Maintained Trial Master File and electronic Trial Master File in compliance with ICH-GCP and company SOPs
- Reviewed and upheld study-level training documentation to meet regulatory standards
- Supported CTM in managing training records according to training matrix requirements
- Assisted in preparation of essential study documents, including ICF and study plans
- Assisted in reviewing visit reports ensuring proper oversight
- Acted as primary liaison for vendors, project teams, and clients to facilitate communication
- Led vendor management calls to address issues and track document progress
- Participated in Investigator Meetings to discuss study updates and issues.
- Participated in Clinical Study Team meetings and led vendor-related issues, document tracking tools, dashboards, and templates
- Assisted in the preparation of regulatory submissions and compliance documents.
Sr. Clinical Trial Specialist
Theravance Biopharma
San Francisco, California
02.2020 - 12.2021
- Supported Clinical Study Manager with site selection and approval processes
- Reviewed and approved PSSV, SIV, and IMV reports for compliance
- Participated in contract and budget meetings to ensure alignment
- Assisted with data cleaning and quality control for clinical data
- Tracked essential documents, screening, enrollment progress, and CRF flow in absence of CRO
- Developed study guides, plans, worksheets, and quick reference materials to support studies
- Managed vendor activities and coordinated Investigator Meetings and CRA workshops
- Contributed to Inspection Readiness process and participated in cross-functional improvement groups
- Contributed to development of recruitment strategies and materials
- Coordinated clinical trial activities in compliance with regulatory guidelines.
Associate Project Leader
Duke Clinical Research Institute
Durham, NC
07.2019 - 09.2019
- Organized and participated in the project kickoff meetings and training, as well as the investigator meetings; presented materials as appropriate
- Analyzed and reviewed project tracking reports and metrics on a weekly basis during project evaluations.
- Generated, tracked, and resolved data queries; identified site and data trends, and recommended actions to project leaders.
- Analyzed enrollment data and reported inconsistencies.
- Read and understood project protocol documents, and created protocol training materials for the team
- Participated in the modification of department-specific and project-specific SOPs and guidelines
- Led meetings to review project status, challenges, and future actions collaboratively.
- Supported budget tracking to maintain financial oversight of clinical research projects.
- Prepared presentations highlighting key findings from project analysis activities.
Initiation Clinical Site Manager II
Parexel International
Durham, NC
11.2018 - 07.2019
- Coordinated site processes from selection to initiation during start-up phase
- Managed and executed the site identification process
- Distribute and collect site feasibility questionnaires
- Served as primary liaison for clinical sites, ensuring quality and timely delivery during pre-SIV/start-up phase.
- Developed strategies to configure, distribute, and collect, and review and approve, high quality country specific and/or site-specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation
- Built relationships with investigators and site staff
- Customized, reviewed, and negotiated as needed, country/site specific Informed Consent Forms (ICF), translations, and amendments
- Prepared and submittedIRB/IEC applications in accordance with country/regulatory/client requirements
- Assisted with forecast, development, and management of plans and strategies for site activation, patient recruitment, and retention
- Maintained a working knowledge of and ensure compliance with applicable ICH-GCP requirements, international and local regulations, PAREXEL standard operating procedures (SOPs), other PAREXEL/Sponsor training requirements and study specific procedures
- Actively participated in Investigator and other external or internal meetings, audits, and regulatory inspections as required
- Worked independently and managed multiple priorities to achieve project timelines.
- Used site management experience and understanding of clinical trials methodology to demonstrate leadership and problem solving.
- Used substantial site start up experience and strong understanding of clinical trials methodology to demonstrate team leadership within start up
Initiation Clinical Site Manager I
Parexel International
Durham, NC
01.2018 - 11.2018
- Clinical sites main point of contact, accountable for quality and delivery of sites during the pre-SIV / start-up phase
- Built relationships with investigators and site staff
- Developed strategies to configure, distribute, and collect, and review and approve, high quality country specific and/or site-specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation
- Customized, reviewed, and negotiated as needed, country/site specific Informed Consent Forms (ICF), translations, and amendments
- Prepared and submitted IRB/IEC applications in accordance with country/regulatory/client requirements
- Assisted with forecast, development, and management of plans and strategies for site activation, patient recruitment, and retention
- Maintained a working knowledge of and ensure compliance with applicable ICH-GCP requirements, international and local regulations, PAREXEL standard operating procedures (SOPs), other PAREXEL/Sponsor training requirements and study specific procedures
- Actively participated in Investigator and other external or internal meetings, audits, and regulatory inspections as required
Clinical Monitoring Associate (In-house CRA)
Parexel International
Durham, NC
07.2014 - 01.2018
- Collaborated with cross-functional teams to ensure project alignment
- Communicated updates on project status to team members effectively
- Performed remote clinical monitoring tasks and remote visits for designated projects in accordance with relevant SOPs, study specific procedures and regulations
- Generated contact reports in accordance with departmental timelines
- Conducted remote visits (initiation, monitoring, termination), if applicable
- Collaborated with CRA on site to resolve issues/actions
- Performed co-monitoring site visits with CRAs
- Maintained a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOP and study specific procedures
- Conducted and facilitated specific start-up activities such as Regulatory document collection, ICF negotiation and all supporting site management activities to ensure timely site initiation
- Ensured all assigned sites are meeting and/or surpassing their recruitment goals
- Responsible for the completeness and quality of the trial master file
- Conducted outbound and inbound calls to review recruitment plan, enrollment updates, address/resolve issues pending from the previous on-site visit, address protocol questions, confirm site staff assignment, support with drug/supply issues, and request outstanding regulatory document and review site payments
- Performed regular reviews of site level data (e.g. CTMS, EDC, IVRS, ISIS) and ensured timely and high quality data entry compliance from sites
- Maintained site staff details in CTMS
- Collected updated/amended regulatory documents in collaboration with CRA and CTS as needed
- Proactively work with other project team member and prioritize multiple tasks to meet project goals
- Ensured timely resolution and closure of all site issues (including Central File QC findings)
- Re-trained site staff on study specific tasks/procedures remotely as required
- Prepared sites and CRAs for on-site visits
Education
Master of Science - Clinical Research
Campbell University
Buies Creek, NC12-2012
Bachelor of Science - Chemistry
Winston Salem State University
Winston-Salem, NC05-2008
Skills
- Contract negotiation
- Vendor management
- Risk mitigation
- Budget oversight
- RFP development
- Clinical trials knowledge
- Project Management
- Vendor evaluation
- Analytical skills
- Procurement strategy
Accomplishments
CRA training -Barnett International, Online, 09Feb2021
Vendor/CRO Management and Oversight MasterClass –GLC Europe, Online, 04-05Nov2021
THERAPEUTIC AREAS
Respiratory
Early Phase Oncology
Immunology
Inflammatory Bowel Disease
Neurology
Timeline
Vendor Strategy Manager, FSP Pfizer
KPS Life
12.2023 - 09.2025
Clinical Trial Assistant
Zentalis
10.2022 - 07.2023
Vendor Project Manager
ICON
12.2021 - 09.2023
Sr. Clinical Trial Specialist
Theravance Biopharma
02.2020 - 12.2021
Associate Project Leader
Duke Clinical Research Institute
07.2019 - 09.2019
Initiation Clinical Site Manager II
Parexel International
11.2018 - 07.2019
Initiation Clinical Site Manager I
Parexel International
01.2018 - 11.2018
Clinical Monitoring Associate (In-house CRA)
Parexel International
07.2014 - 01.2018
Master of Science - Clinical Research
Campbell University
Bachelor of Science - Chemistry
Winston Salem State University