Whitney Escalante
Montgomery,TX
Summary
Clinical Operations Leader with 10+ years of experience. Skilled in overseeing end-to-end trial execution, regulatory compliance, and cross-functional team leadership. Proven ability to drive operational excellence, optimize study performance, and ensure adherence to ICH-GCP, FDA, and EMA regulations.
Overview
13
13
years of professional experience
Work History
Senior Clinical Trial Manager
Karyopharm Therapeutics, Inc.
03.2023 - Current
- Oversee the planning, implementation, execution, and management of global clinical trials from start-up through closeout, ensuring adherence to timelines, budget, and regulatory requirements.
- Manage CROs and third-party vendors, ensuring deliverables align with the Statement of Work (SOW) and budgetary constraints.
- Lead cross-functional teams to drive successful trial execution, meeting all key milestones
- Author, review, and approve study-related documents, including protocols, informed consent forms (ICFs), case report forms (CRFs), and study plans.
- Identify potential study risks and collaborate cross-functionally to implement mitigation strategies and escalate issues when necessary.
- Lead study-specific training, investigator meetings, and the development of clinical trial materials to ensure consistency and compliance.
- Ensure inspection readiness by maintaining Trial Master File (TMF) accuracy and engaging study teams in best practices for regulatory preparedness.
- Provide financial oversight for clinical trials, ensuring adherence to pre-approved budgets and proactively managing cost-related risks.
- Serve as the subject matter expert (SME) for assigned trials during regulatory inspections, ensuring compliance with ICH-GCP, FDA, and EMA standards.
- Mentor and provide guidance to junior team members, fostering professional development and process improvement.
Clinical Trial Lead
EQRx
08.2021 - 03.2023
- Led operational and monitoring oversight for a global Phase III oncology trial and Phase I JAK-inhibitor trial, ensuring full compliance with ICH-GCP, FDA, and EMA regulations while driving trial efficiency and data integrity.
- Oversaw CROs, vendors, and investigative sites, optimizing trial execution and patient recruitment.
- Led cross-functional teams to drive successful trial execution, meeting all key milestones.
- Implemented the company’s first FSP monitoring team, developing job descriptions, onboarding processes, and oversight metrics.
- Developed and implemented trial processes and manuals for execution of in-house studies.
- Served as Clinical Operations Lead for UAT of trial systems.
- Drafted study materials, including trainings, manuals, and supporting documents.
- Conducted monitoring activities for in-house studies and strategic master programs.
- Reviewed monitoring reports and study data to identify trends and deviations.
- Mentored CTAs, CRAs, and CTLs to support career growth.
Clinical Research Associate
Clinipace
02.2020 - 06.2021
- Developed study documents, trainings, and SOPs during COVID-19.
- Created iRECIST training materials for novice CRAs.
- Tested system functionality through UATs, identifying and resolving issues pre-deployment.
- Drafted informed consent templates across multiple studies.
- Performed site monitoring to ensure compliance with regulatory requirements, ICH/GCP guidelines, and SOPs.
- Managed site activities, including study tracking, team communications, and remote monitoring.
- Applied therapeutic area knowledge to assignments and project-related issues.
- Built strong relationships with site staff and sponsors.
- Ensured timely and accurate AE/SAE reporting, protecting subject safety.
- Conducted remote site evaluation, initiation, and interim visits.
- Experienced in electronic data capture (EDC) and electronic medical records (EMR).
- Collected and tracked regulatory documentation to maintain compliance.
Clinical Research Associate
Pharm-Olam International
10.2019 - 02.2020
- Performed site monitoring to ensure compliance with regulatory requirements, ICH/GCP guidelines, and SOPs.
- Managed data review and query resolution, ensuring completeness and consistency.
- Applied therapeutic area knowledge to assignments and project-related issues.
- Built strong relationships with site staff and sponsors to drive study success.
- Ensured timely and accurate AE/SAE reporting, protecting subject safety.
- Oversaw investigational product accountability and security.
- Executed site evaluation, initiation, interim, and close-out visits.
- Collected and tracked regulatory documentation to maintain compliance.
Manager, Clinical Support
Pharm-Olam International
02.2017 - 09.2019
- Managed a regional team of 18 Clinical Trial Associates (CTAs) for a mid-sized CRO, overseeing ~40 trials.
- Drove study deliverables within timelines and budget through cross-functional collaboration.
- Developed CTA job descriptions and training to align regional practices with global standards.
- Oversaw trial and department resourcing, ensuring optimal allocation.
- Analyzed system data and reports to identify trends and recommend alternative solutions.
- Handled trial escalations and provided strategic resolutions.
- Reported key performance and delivery metrics to leadership.
- Led cross-functional teams to improve internal efficiencies.
- Contributed to SOP development and global system implementation.
Sr. Clinical Trial Associate
Pharm-Olam International
07.2016 - 01.2017
- Served as administrative lead for a Phase I oncology trial.
- Tracked study deliverables and reported to study team.
- Developed trial newsletters and study communications for sites and staff.
- Organized meetings, documented minutes, and ensured timely follow-ups.
- Supported CRAs in monitoring visits and audit preparation.
- Ensured compliance with GCP, regulatory, and ethical guidelines.
Clinical Trial Associate
US Oncology Network
12.2015 - 07.2016
- Managed multiple clinical research studies across Phases I–III.
- Served as primary liaison between USON, sponsors, and network sites.
- Developed reports for internal management and external clients.
- Coordinated trial updates across budget, contracts, and regulatory teams.
- Created feasibility questionnaires and assisted in site selection analysis.
- Ensured contracts and budgets aligned with protocol requirements.
Clinical Research Coordinator
Hill Country Clinical Research
03.2012 - 11.2015
- Executed investigator-initiated trials in collaboration with PI, study staff, and sponsors.
- Conducted patient visits and performed orthopedic assessments.
- Collected and entered data into case report forms (CRFs).
- Managed regulatory upkeep and IRB submissions.
Education
Bachelor of Science - Psychology, Biology
The University of Texas
Skills
- Oncology Clinical Trial Management (Phase I/II/III)
- Leadership & Team Oversight
- Vendor & CRO Management
- Budgeting & Resource Allocation
- Risk & Quality Management
- Clinical Trial Protocol Development
- Site Engagement & Patient Recruitment
Accomplishments
- Rheumatoid Arthritis – Phase I
- Oncology (Biologics and Small Molecules) – Phases I–III
- Orthopedics – Phase IV
Recognitions
- Karyopharm eXceptional Partner Award – September 2024
- Karyopharm DevOps Recognition Award – March 2024
- Pharm-Olam Employee Leadership Award (Top 10 Finalist out of 700+ employees) – December 2017, October 2018, December 2018
Timeline
Senior Clinical Trial Manager
Karyopharm Therapeutics, Inc.
03.2023 - Current
Clinical Trial Lead
EQRx
08.2021 - 03.2023
Clinical Research Associate
Clinipace
02.2020 - 06.2021
Clinical Research Associate
Pharm-Olam International
10.2019 - 02.2020
Manager, Clinical Support
Pharm-Olam International
02.2017 - 09.2019
Sr. Clinical Trial Associate
Pharm-Olam International
07.2016 - 01.2017
Clinical Trial Associate
US Oncology Network
12.2015 - 07.2016
Clinical Research Coordinator
Hill Country Clinical Research
03.2012 - 11.2015
Bachelor of Science - Psychology, Biology
The University of Texas
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