Maryjane Talamantes
Las Vegas,NV
Summary
Senior Clinical Study Manager with 11+ years experience leading Phase I–III global clinical trials across North and South America, EMEA, Asia Pacific, and Sub-Saharan Africa.
My background spans opthalmology, oncology(Hema-oncology and immuno-oncology) IVD and device–drug development programs, with responsibility for multinational operational execution under diverse regulatory frameworks. I lead cross-functional teams across Clinical, Regulatory, Medical Affairs, Data Management, and vendor partners to deliver inspection-ready trials across multiple geographies.
I have overseen:
• Early- and late-phase global clinical trials from start-up to CSR.
• Multi-regional regulatory coordination
• CRO and specialty vendor strategy and performance governance
• Risk-based study management and audit preparedness
Overview
12
12
years of professional experience
1
1
Certification
Work History
SENIOR CLINICAL STUDY MANAGER
Therakos
02.2026 - Current
- Sponsor-side lead for outsourced clinical programs, serving as primary accountability owner for CRO and third-party vendor performance.
- Direct oversight of vendor governance including selection, onboarding, KPIs, and contractual compliance to ensure regulatory-ready study execution.
- Owns end-to-end study execution including timelines, financial forecasting, risk assessment, and milestone delivery aligned with regulatory strategy.
- Works with the clinical development team to develop core study documents including protocols, ICFs, study plans, and CSR deliverables prior to regulatory submission.
- Partners cross-functionally with Regulatory, Data Management, Pharmacovigilance, Quality, and Clinical Development to drive execution strategy.
- Leads financial oversight of CRO and vendor budgets, tracking forecast variance and cost performance.
- Ensures audit readiness and inspection support to ensure ICH-GCP and SOP compliance.
- Leads complex issue resolution and decision-making to protect study critical path and corporate development timelines.
- Develops detailed project plans for multiple clinical trials simultaneously.
- Creates comprehensive training materials for staff members, enhancing their understanding of protocol requirements and increasing adherence rates.
- Manages over 34 sites globally.
CLINICAL TRIAL MANAGER
Roche
08.2019 - 01.2026
- Led clinical trial operations for oncology therapeutic studies (hematology, solid tumor, immuno-oncology) alongside medical device and diagnostic trials, including biomarker assays and companion diagnostics supporting oncology programs.
- Oversaw global Phase II–III oncology trials and device/combination product studies, ensuring ICH-GCP, FDA, and EMA compliance across North America, EU, and Asia-Pacific regions.
- Worked with cross-functional teams (medical affairs, regulatory, biostatistics, pharmacovigilance and regulatory affairs) to deliver 95% on-time trial milestones and regulatory submissions.
- Drove vendor and CRO oversight, contract negotiations, and clinical monitoring strategy for both drug and device portfolios, strengthening cross-portfolio trial management expertise.
- Drafted and reviewed informed consent forms, study manuals, investigator brochures and other related documents.
- Coordinated Site selection, initiation and monitoring across 50+ global clinical sites, improving investigator engagement and patient recruitment strategies.
- Supported IND, IDE AND NDA filings.
- Implemented innovative digital health tools (eCOA, ePRO, and remote monitoring devices) to enhance patient adherence and trial data capture.
- Mentored junior operations team members, providing leadership in trial management processes, quality standards, and regulatory compliance.
- Reviewed monitoring visit reports submitted by CRAs to ensure that all observations are addressed in a timely manner.
SENIOR CLINICAL RESEARCH ASSOCIATE
Ora Inc.
04.2017 - 06.2019
- Conducted site qualification, initiation, monitoring, and close-out visits for Phase I–III clinical trials in ophthalmology, covering both drug and medical device programs (intraocular lenses, ocular implants, diagnostic devices).
- Ensured ICH-GCP compliance, informed consent accuracy, and patient safety across 15+ investigator sites in the U.S.
- Performed source data verification (SDV), reviewed case report forms (CRFs), and managed query resolution to maintain high-quality data integrity.
- Collaborated closely with investigators, coordinators, and site staff to address protocol deviations, enhance patient recruitment, and optimize study timelines.
- Prepared detailed monitoring visit reports and escalated critical issues to project management and sponsors in a timely manner.
- Supported regulatory submissions and sponsor audits, ensuring trial master file (TMF) completeness and inspection readiness.
- Worked with cross-functional teams to support study execution for both pharma and biotech sponsors.
CLINICAL RESEARCH ASSOCIATE
Ora Inc.
04.2014 - 03.2017
- Assisted senior CRAs in conducting site qualification, initiation, routine monitoring, and close-out visits for ophthalmology clinical trials involving drug, medical device, and combination products.
- Performed essential document collection and review for investigator site files and Trial Master File (TMF) to ensure inspection readiness.
- Supported source data verification (SDV) by cross-checking case report forms (CRFs) against source documents and flagging discrepancies for resolution.
- Observed and later conducted supervised patient informed consent checks, ensuring compliance with ICH-GCP and protocol requirements.
- Assisted with safety data collection, including adverse event (AE) and serious adverse event (SAE) documentation and reporting.
- Drafted and maintained monitoring visit reports under senior CRA guidance, documenting protocol deviations, data issues, and corrective actions.
- Coordinated with study sites to facilitate patient recruitment strategies and provide ongoing support to site coordinators and investigators.
- Gained experience across multiple ophthalmology therapeutic areas including glaucoma, dry eye, retinal disease, and ocular surgical implants.
Education
BACHELOR OF SCIENCE (B.S.) - PHARMACOLOGY
Delta State University
Skills
- Clinical Trial Management (Phase I–III, Global Operations)
- Site Monitoring, Source Data Verification (SDV) & TMF/eTMF Systems
- Cross-Functional Team Leadership & Mentorship
- Vendor/CRO Oversight & Stakeholder Collaboration
- Proficiency in EDC, CTMS & eTMF systems (Medidata Rave, Oracle InForm, Veeva Vault)
- Oncology, Ophthalmology & Medical Device Trials
- Regulatory Compliance (ICH-GCP, FDA, EMA, MHRA)
- Investigator & Site Relationship Management
- Excellent Communication & interpersonal skills
Certification
- Cancer Genomics and Precision Oncology
- Drug Discovery and Development
- Project Management Professional PMP.
Languages
English
Native or Bilingual
Spanish
Professional Working
Timeline
SENIOR CLINICAL STUDY MANAGER
Therakos
02.2026 - Current
CLINICAL TRIAL MANAGER
Roche
08.2019 - 01.2026
SENIOR CLINICAL RESEARCH ASSOCIATE
Ora Inc.
04.2017 - 06.2019
CLINICAL RESEARCH ASSOCIATE
Ora Inc.
04.2014 - 03.2017
BACHELOR OF SCIENCE (B.S.) - PHARMACOLOGY
Delta State University
THERAPEUTIC EXPERTISE
- Oncology: Hematology, immuno-oncology, and solid tumors (Phase I–III).
- Ophthalmology: Glaucoma, retinal disease, dry eye, ocular inflammation, intraocular lenses & implants.
- Medical Devices & Combination Products: Ocular implants, ECP, diagnostic platforms, companion diagnostics, Software as a Medical Device (SaMD)