Mallory Bryce
@mallorybryce
Clinical operations leader managing North America site delivery, compliance, and start-up execution end-to-end.
United StatesWhat I'm looking for
I lead North America clinical network execution with direct line management responsibility for operational staff. I’m accountable for delivering on-time, high quality site-level end-to-end deliverables, from site outreach and remote PSVs to site startup, regulatory greenlight, and site certifications for ready to enroll.
I serve as a Country Manager and subject matter expert for end-to-end site processes, timelines, training, and systems—including Veeva Vault (as Unified Clinical Vault), eTMF, and the Quality Management System. I ensure delivery of country-level deliverables, timelines, and compliance with legal and regulatory requirements for study activation and maintenance.
I bring deep start-up and regulatory experience from roles including Start-Up Project Manager / Senior Start-Up Specialist and Start-Up Specialist II. I reviewed, negotiated, and finalized informed consent forms for legal and regulatory compliance across U.S. and international jurisdictions, and I managed regulatory documentation aligned with FDA, Health Canada, HIPAA, and ICH-GCP requirements.
I also strengthen execution through contract and budget ownership and cross-functional collaboration. I directed staff in contract negotiation and budget development, aligned financial decisions with strategic priorities, supported IRB/IEC submission packages, maintained audit-ready Trial Master Files, and delivered department-wide training on regulatory interpretation and documentation standards.
Experience
Work history, roles, and key accomplishments
Managed North America clinical network operations, delivering end-to-end site deliverables including site outreach, remote PSVs, startup, certifications/equipment readiness, remote RMVs, site maintenance, and regulatory greenlights. Led contract and budget development, served as Country Manager/SME for country-level compliance and site processes, and supported role training across the department u
Served as Lead North America Specialist and Dual-Role Start-Up Project Manager, handling escalations on complex contract and informed consent negotiations. Reviewed, negotiated, and finalized informed consent forms and regulatory documentation aligned to FDA, Health Canada, HIPAA, and ICH-GCP requirements while coordinating cross-functional legal and CRO partners to resolve compliance barriers.
Conducted legal and regulatory review of site documentation and informed consents to ensure country-specific compliance. Acted as regional regulatory SME, maintained audit-ready Trial Master Files, and supported IRB/IEC submission packages while advising stakeholders on procedural risks and compliance requirements.
Executed compliance reviews of regulatory packets, informed consents, and legal documents under FDA and Health Canada regulations. Served as liaison between clinical sites, legal teams, clients, and IRBs to resolve approvals and maintained contract-related TMF documentation to support governance activities and amendments.
Research Coordination Specialist
Pharmaceutical Product Development (PPD)
Apr 2014 - Jun 2015 (1 year 2 months)
Reviewed regulatory and legal documents for quality, accuracy, and compliance ahead of IRB, client, or regulatory submissions. Prepared study-specific process manuals to support operational governance and helped train administrative staff on compliance processes and documentation standards.
Education
Degrees, certifications, and relevant coursework
University of Oklahoma, College of Law
Master of Legal Studies, Legal Studies
Master of Legal Studies at the University of Oklahoma College of Law, expected completion in 2026.
University of North Carolina at Wilmington
Bachelor of Arts, Psychology
2011 -
Bachelor of Arts in Psychology at the University of North Carolina at Wilmington (starting in 2011).
University of North Carolina at Wilmington
Bachelor of Arts, French
2011 -
Bachelor of Arts in French at the University of North Carolina at Wilmington (starting in 2011).
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
Interested in hiring Mallory?
You can contact Mallory and 90k+ other talented remote workers on Himalayas.
Message MalloryFind your dream job
Sign up now and join over 100,000 remote workers who receive personalized job alerts, curated job matches, and more for free!
