Clinical Trial Manager

MICHELL RIST

Hilton, NY ***** 585-***-**** *******.****@*****.*** LinkedIn URL

Clinical Trial Manager Research Director Senior RFI Analyst Driving successful clinical trials and RFI processes with expertise in compliance, strategic leadership, and client satisfaction Results-driven Clinical Trial Manager with 10+ years of experience in clinical research, RFI/RFQ management, and team leadership. Successfully led high-profile trials, secured multi-million-dollar accounts, and developed company-wide training programs. Proven track record in auditing, compliance, and delivering complex projects on time. Adept at fostering collaboration across cross-functional teams, ensuring operational excellence, and exceeding client expectations. Equipped with strong business acumen and Six Sigma Yellow Belt certification, consistently driving process improvements and organizational success. CORE COMPETENCIES

Clinical Trial Management

RFI/RFQ Process Management

CAPA Implementation

Stakeholder Collaboration

FDA & Regulatory Compliance

SOP Development

Cross-Functional Team Leadership

Project & Timeline Management

Strategic Account Acquisition

Clinical Data Auditing

Quality Assurance & Control

Training & Development

Vendor Management

Site Documentation Management

Risk Mitigation

Process Improvement

Budget and Resource Allocation

Client Relationship Management

FDA Audits

Finance

GCP

PROFESSIONAL EXPERIENCE

SENIOR ANALYST Clario

Hilton, NY (August 2020 – July 2024)

Budget and Contract Submissions to Sponsors (including Rate Cards)

Spearheaded the management of RFI/RFQ processes, overseeing requests through the Clario proposal system and delivering accurate, tailored responses aligned with complex client specifications.

Collaborated with SMEs to gather and refine technical details, driving the development of precise RFI/RFQ submissions that bolstered client relationships and secured business success.

Curated and maintained a robust library of SME content, streamlining response workflows and improving overall submission speed and efficiency across multiple departments.

Led thorough reviews of SME-provided responses, elevating content quality and delivering consistent, high- standard information for all client-facing documents.

Worked with cross-functional teams to expedite the delivery of imaging RFIs, consistently meeting strict deadlines and achieving high levels of client satisfaction. Key Accomplishments:

Orchestrated strategic meetings with key stakeholders at AstraZeneca and Samsung, securing a $2.6 million account and elevating Clario to preferred provider status.

Designed and implemented training programs for remote employees, standardizing workflows and developing workbooks that were adopted across the company to enhance RFI processing efficiency.

Partnered with the Contracts Department to craft precise statements of work for major clients, including AstraZeneca, Moderna, and Samsung, ensuring flawless execution and timely delivery. Michell Rist Page 2

585-***-**** • *******.****@*****.***

CLINICAL RESEARCHER BioTel Research

Rochester, NY (January 2015 –January 2020)

Directed internal and external audits of data centers, media storage, and trial sites, driving compliance with clinical standards and managing CAPAs to implement effective quality improvements.

Acted as the primary liaison for imaging and cardiac sites, overseeing end-to-end trial communications, documentation, and training from initial qualification to study completion, ensuring smooth trial operations.

Developed and delivered customized communication templates and training programs via WebEx, significantly enhancing clinical trial efficiency and ensuring staff readiness for trial processes.

Provided continuous site support through email and phone, troubleshooting issues related to trial equipment, logistics, and documentation, and ensuring adherence to SOPs and trial protocols.

Managed the tracking, recall, and reconciliation of clinical trial materials, coordinating shipments, allocating budgets, and adhering to regulatory standards throughout the trial lifecycle. Key Accomplishments:

Created and delivered comprehensive ECG machine training materials within a 24-hour timeframe for a sponsor, exceeding expectations and facilitating uninterrupted trial operations.

Led the preparation of 100% accurate documentation for 10 oncology studies during an FDA audit, collaborating with the Quality Team to ensure full compliance and audit readiness.

Took charge of an oncology project when the project owner went on disability, managing timelines and hosting weekly meetings to successfully deliver the project within the 1-year deadline.

Achieved 100% completion of weekly audits, ensuring all documentation and processes were meticulously accurate and up-to-date across multiple clinical trials.

Qualified 100% of clinical trial sites for participation, significantly contributing to the overall success and seamless progression of the studies.

Returned 90% of clinical trial equipment within a year, maintaining compliance with trial procedures and ensuring efficient management of trial-related resources. Early Career Experience:

PAYROLL ADMINISTRATOR Xerox Corporation – Henrietta, NY MANAGER & TRAINER Sporting Dog Specialties – Brockport, NY EDUCATION & PROFESSIONAL DEVELOPMENT

BACHELOR'S OF SCIENCE IN BUSINESS University of Phoenix Technical Skills: WebEx BlueJeans ADP Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) Google Workspace (Docs, Forms, Sheets)

Training, Licenses, Certifications, & Awards:

Six Sigma Yellow Belt Training

Customer Centrix Training

LinkedIn Learning Awards

Dean's List Awards

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