Project Manager Rare Disease

Kandra Greaves

Clinical Biomarker and Diagnostics Project Manager

*******@*****.*** www.linkedin.com/in/kandragreaves 404-***-****

PROFESSIONAL SUMMARY

Results-driven clinical operations professional with over 8 years of experience in study management and execution, biospecimen lifecycle management, and medical imaging data integration for oncology and rare disease clinical trials. Proficient in overseeing CROs, vendors, and site operations to ensure compliance with HIPAA, GCP, ICH, and GLP regulations. Skilled in cross-functional leadership, developing study-specific documentation, and driving high-quality data delivery to support drug development and study design. Certified in HIPAA/PHI, human subjects protection, and GCP, with expertise in TMF management, vendor oversight, and risk mitigation. Adept at fostering agility, proactivity, and collaboration to meet study timelines, budgets, and quality standards.

PROFESSIONAL EXPERIENCE

Clinical Biomarker and Diagnostics Operations Lead Amgen Mar 2024 - Mar 2025

Provided strategic direction as operational partner to biomarker scientific leads, contributing to study design and execution for Phase 1/2 rare disease clinical trials, aligning with clinical development plans.

Oversaw end-to-end biospecimen lifecycle management, coordinating sample receipt, testing, and disposition, ensuring compliance with ICH, GCP, and GLP regulations and meeting study timelines.

Developed study-specific documentation, including SOPs, work instructions, and site training materials, enhancing operational efficiency and compliance.

Managed vendor relationships (CROs, central labs) and oversaw SOWs, budgets, and invoices, resolving escalations to maintain data integrity and study quality.

Created dashboards and KPIs to track sample testing metrics and study progress, presenting insights to cross-functional study execution teams to support decision-making.

Facilitated IRB/EC submissions and essential document management in eTMF, ensuring accurate filing and regulatory compliance throughout the study lifecycle.

Led risk identification and mitigation efforts, issuing data clarification forms to resolve protocol deviations and ensure high-quality data for database locks.

Medical Imaging Data Specialist Prolink July 2024

Conducted quality control and data annotation for CT/MRI imaging datasets, ensuring compliance with HIPAA, GCP, and internal protocols for rare disease trials.

Oversaw imaging data workflows using QMS and FogBugz, managing query resolution and escalations to maintain data integrity.

Supported cross-functional teams in integrating imaging data with clinical datasets, contributing to patient stratification and study execution.

Coordinated electronic data conversions with vendors, ensuring accurate data mapping and quality assurance during HER transitions.

Biomarker Project Manager/Clinical Associate Biogen Apr 2022 - Oct 2023

Managed clinical sample lifecycle for Phase 3 oncology and neuroscience trials, overseeing site feasibility, sample collection, and data transfers to ensure compliance with GCP/GLP.

Developed study-specific documentation, including protocols, SOWs, and training materials, and presented at investigator meetings to support site readiness.

Oversaw CROs and central labs, managing budgets, POs, and invoices, and resolving discrepancies to meet study timelines and quality standards.

Maintained TMF accuracy, processed documents via DocuSign, and tracked screening authorization forms, ensuring regulatory compliance and study lifecycle management.

Created project plans and dashboards to monitor study progress, driving query resolution and timely data reporting for database locks.

Clinical Team Manager/Site Management PPD Oct 2021 - Mar 2022

Provided global oversight of site operations, including site qualification, training, and compliance with ICH/GCP, ensuring high-quality data and study monitoring.

Coordinated with site coordinators and vendors to optimize biospecimen collection and shipment, enhancing operational efficiency and study execution.

Monitored studies for protocol deviations, issuing data clarification forms and contributing to risk mitigation strategies to maintain data quality.

Clinical Research Coordinator Emory University Mar 2019 - Feb 2021

Managed Phase I-IV clinical research projects in rare diseases, overseeing site feasibility, participant screening, and sample collection while ensuring compliance with regulatory requirements.

Developed study-related documentation (e.g., case report forms, flow sheets) and conducted data quality reviews to resolve discrepancies in clinical databases.

Collaborated with cross-functional teams to support study execution, risk identification, and mitigation, ensuring timely delivery of high-quality data.

Computed Tomography Technologist, PRN Numed Inc. Nov 2018

Operated CT equipment to produce diagnostic images, adhering to safety protocols and ensuring HIPAA compliance in clinical workflows.

Managed patient data in HIS/RIS systems, supporting accurate data mapping and quality assurance for radiology processes

CORE SKILLS

Study Management and Execution: Study design, site feasibility, vendor oversight, TMF management, risk mitigation

Compliance and Quality: ICH, GCP, GLP, HIPAA, CDISC, SDTM, CDASH

Drug Development and Study Design: Clinical development plans, patient stratification, biomarker integration

Product and Therapeutic Area Knowledge: Rare diseases, oncology, medical imaging (MRI, CT, PET)

Technical Proficiency: StarLIMS, CTMS, EDC, Veeva Vault, IRT, Smartsheet, Microsoft Excel (macros), DocuSign

Leadership and Collaboration: Cross-functional team leadership, investigator meeting facilitation, vendor relationship management

Agility and Proactivity: Query resolution, risk identification, process optimization

Communication: Study progress reporting, meeting minute documentation, stakeholder engagement

EDUCATION

Bachelor of Science in Biology University of South Carolina May 2000

CERTIFICATIONS

Certified Associate in Project Management Project Management Institute May 2018

HIPAA/PHI Privacy Certification

Human Subjects Protection Certification

Good Clinical Practice (GCP) Certification

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