Nonyelum Martins

• Oversaw Full Cycle of Clinical Trials: Managed clinical trials from protocol initiation to study completion, ensuring the adherence to timelines, regulatory requirements, and the overall study plan. Led clinical trial site activities and ensured timely initiation, monitoring, and close-out visits for Phase I-IV oncology trials.
• Regulatory Compliance & Documentation: Collaborated with clinical research sites and CROs to ensure the timely submission of regulatory documents, including informed consent forms, study protocols, and adverse event reports, in compliance with ICH-GCP guidelines. Maintained a meticulous documentation trail for all trial activities to ensure audit readiness.
• Site Monitoring & Quality Control: Conducted comprehensive site visits (qualification, initiation, monitoring, and close-out) to ensure compliance with study protocols, regulatory standards, and patient safety procedures. Developed and implemented robust site monitoring plans, tracking key metrics and ensuring high-quality data collection throughout the study.
• Patient Recruitment & Retention: Led recruitment efforts by developing strategies for patient enrollment and retention, ensuring the successful recruitment of eligible participants while maintaining participant safety and ethical standards. Provided continuous support to patients and site staff to facilitate smooth trial operations.
• Informed Consent & Ethical Oversight: Ensured proper informed consent procedures were followed, providing study participants with clear, concise, and accurate information regarding the study’s purpose, procedures, risks, and benefits. Played a key role in safeguarding patient rights and confidentiality throughout the clinical trial process.
• Data Management & Monitoring: Utilized Electronic Data Capture (EDC) systems to collect and verify clinical trial data, ensuring completeness, accuracy, and integrity. Collaborated with data management teams to implement data validation processes, ensuring data consistency and timely reporting.
• Training & Support for Site Personnel: Trained site staff on study-specific protocols, GCP, and regulatory requirements, empowering them to maintain high standards of compliance and data accuracy. Provided ongoing support to site staff and answered queries related to trial procedures and documentation.
• Cross-Functional Collaboration: Worked closely with physicians, research coordinators, CRAs, and other key stakeholders to ensure smooth study execution. Facilitated open communication across teams, addressing any issues or challenges quickly and effectively to ensure the continuity of trial activities.

Oncology Trials:

• Atezolizumab + Nab-Paclitaxel in Metastatic TNBC (Phase III)
• CAR-T Therapy in Relapsed/Refractory DLBCL (Phase II)
• First-in-Human Trial of KRAS G12C Inhibitor in NSCLC (Phase I)

• Supported monitoring and site management for early-phase dermatology trials in moderate-to-severe plaque psoriasis, atopic dermatitis, and hidradenitis suppurativa.
• Ensured accurate source documentation and compliance with ICF procedures during biologic trials for IL-17 and IL-23 inhibitors.
• Worked closely with dermatologists to assess EASI and PASI scores, documenting efficacy outcomes.
• Conducted IP accountability and managed site start-up documents including 1572s and financial disclosures.
• Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
• Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
• Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.

Dermatology Trials:

• Secukinumab vs Placebo in Chronic Plaque Psoriasis (Phase III)
• Dupilumab for Atopic Dermatitis in Adolescents (Phase III)
• JAK Inhibitor Topical Application for Vitiligo (Phase II)

• Monitored multiple Phase II–III COVID-19 trials involving mRNA vaccines, antiviral agents (e.g., molnupiravir), and monoclonal antibodies (e.g., bamlanivimab) for outpatient and hospitalized patients.
• Conducted over 50 site visits, both remote and on-site, verifying protocol adherence, informed consent processes, and IP accountability.
• Managed SAE reporting, deviation tracking, and adverse event reconciliation across global sites under Emergency Use Authorization (EUA) regulations.
• Collaborated with centralized labs and CROs for PCR result verification, serologic endpoints, and lab data QC.
• Ensured data entry in eCRFs (RAVE) and participated in database lock meetings under compressed timelines.

COVID-19 Trials:

• Phase III mRNA COVID-19 Vaccine Trial (sponsored by major biotech firm)
• Oral Antiviral Therapy for Mild-to-Moderate COVID-19 (Molnupiravir)
• Monoclonal Antibody Combination for Severe COVID-19 Patients (Emergency IND)

• Clinical Trial Lifecycle Management: Directed the end-to-end administration of clinical trials by overseeing site qualification, initiation, interim monitoring, and close-out activities, ensuring each phase met protocol standards and regulatory expectations while maintaining the highest level of compliance and data integrity.
• Regulatory Documentation Oversight: Orchestrated the management, validation, and archival of essential trial documents, including protocols, informed consent forms, and clinical study reports, meticulously verifying each document for regulatory compliance, procedural accuracy, and consistency with Good Clinical Practice (GCP) standards.
• Site Monitoring and Quality Assessment: Developed and implemented robust monitoring frameworks to assess and enhance site quality, performing rigorous data verification across case report forms, source documents, and study protocols to ensure uniformity and high standards of data accuracy and reliability.
• Coordination with Contract Research Organizations (CROs): Facilitated seamless collaboration with Contract Research Organizations (CROs), managing the regulatory submission process and ensuring documentation and procedural alignment with compliance protocols and regulatory requirements.
• Training and Compliance Assurance for Site Personnel: Delivered comprehensive training to site personnel on regulatory mandates, GCP standards, and study protocols, cultivating a high standard of adherence to trial requirements and empowering staff to maintain data integrity throughout trial operations.
• Electronic Data Capture (EDC) System Implementation: Spearheaded the development and integration of advanced Electronic Data Capture (EDC) systems, optimizing trial data workflows, reducing redundancies, and enhancing data accuracy for efficient and reliable trial management.
• Liaison Between Sponsors, Investigators, and Regulatory Bodies: Acted as the primary communication conduit among trial sponsors, clinical investigators, and regulatory authorities, fostering transparent, responsive interactions that preemptively addressed discrepancies and upheld compliance with regulatory standards.
• Regulatory Readiness and Site Audit Coordination: Ensured that clinical trial sites were consistently regulatory-ready by conducting periodic audits, rigorously reviewing data consistency, addressing protocol deviations, and implementing corrective measures promptly to maintain operational and data compliance.
• Detailed Site Visit Reporting and Documentation: Produced detailed site visit reports documenting observations, potential deviations, and corrective actions, providing stakeholders with clear insights into trial progress, operational compliance, and data quality, fostering an informed and controlled trial environment.
• Participant Welfare and Ethical Conduct Assurance: Upheld the ethical standards of clinical research by ensuring all trial activities prioritized participant rights and welfare, fostering a compliant, participant-focused research environment that safeguarded both data integrity and the wellbeing of study participants.

• Assisted CRAs in monitoring studies on systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and ankylosing spondylitis (AS).
• Coordinated patient visits, performed eCRF data entry, and conducted SDV with clinical monitors.
• Monitored DAS28 and SLEDAI scores under protocol-specific endpoints.
• Managed investigational product handling for TNF and IL-6 inhibitors, maintaining strict temperature logs.
• Followed informed consent processes and maintained records.
• Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
• Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.

Rheumatology Trials:

• Tocilizumab in Refractory RA (Phase III)
• Belimumab in Active Lupus Nephritis (Phase III)
• IL-17 Inhibitor in Axial Spondyloarthritis (Phase II)