Summary
Overview
Work History
Education
Skills
Key Therapeutic Areas of Expertise
Timeline
Generic

Ayşe Sinem Demiralp

İstanbul

Summary

Clinical Research Leader with over 9 years of hands-on experience managing end-to-end clinical trials across multiple therapeutic areas, with a strong focus on Oncology alongside extensive involvement in Immunology, Cardiology, Psychiatry, Endocrinology, and Nephrology.

Skilled in driving complex, multi-center studies from startup to LSLV with strategic oversight, protocol mastery, and operational precision. Known for exceeding patient recruitment targets (up to 128%), achieving first-in-region milestones, and maintaining consistent audit readiness through proactive risk management and stakeholder alignment.

My leadership approach blends scientific rigor with agile execution—prioritizing patient-centric design, cross-functional synergy, and data integrity at every stage of a trial.

Recipient of the Eli Lilly President’s Award, in recognition of my impact in accelerating oncology research through operational innovation and strategic execution.

Overview

10
10
years of professional experience

Work History

Clinical Trial Manager

ICON Plc (FSP for Eli Lilly)
11.2023 - Current
  • Lead the planning, execution, and oversight of multiple Phase IIb–III clinical trials across Oncology, Immunology, Cardiology, Psychiatry, Endocrinology, and Nephrology in an FSP model, serving as country-level decision-maker for protocol execution, regulatory navigation, and site engagement across Turkey.
  • Delivered EMEA-first startup milestones, including first Site Ready-to-Enroll, first Pre-screening, and first Patient Visit in a seamless study setup.
  • Exceeded oncology enrollment targets by 128% within 6 months through tailored mutation-positive screening and proactive investigator engagement.
  • Recovered a 3-month IP delay in a cardiology trial via early site mobilization and pre-screening; enabled first-patient-in on SIV day and completed full enrollment in 8 months.
  • Completed feasibility for 15+ sites across 10 cities in 3 days and finalized site selection in 15 days, ensuring national representation and site diversity.
  • Launched feasibility across 13 Phase I units, forming the foundation for future early-phase partnerships.
  • Contributed to protocol development through early feasibility input on epidemiology, patient access, and operational viability; influenced I/E criteria and national recruitment scope.
  • Streamlined regulatory submissions and ethics approvals alongside IP, lab kits, ISF, and ancillary logistics, preventing startup delays and enabling synchronized site readiness.
  • Aligned submission strategy with import logistics and local regulatory timelines, enabling first-site activation without delay.
  • Directed performance of vendor-assigned SCs and CRAs via quarterly reviews, workload balancing, and issue escalation.
  • Advocated for vendor restructuring due to local performance misalignment; improvements led to ~20% faster activation and ~15% fewer query delays (per internal tracking and CRA feedback).
  • Prioritized operational resources across overlapping studies, reallocating CRA support based on complexity and sponsor priorities.
  • Defined FTE and staffing plans for long-term CRO resourcing across multi-year portfolios.
  • Tracked CRA/SC KPIs (activation time, deviation rate, query cycle) to trigger timely interventions.
  • Led oncology audit readiness and execution with zero major findings; all action items closed within 10 days.
  • Integrated systems such as CTMS, EDC, eTMF–Veeva Vault, IXRS, SIP, and Power BI into oversight processes to minimize deviations and accelerate timelines.
  • Mitigated lab kit, IP, and B&C risks through centralized tracking tools and cross-functional escalation workflows.
  • Navigated a critical PI payment dispute by maintaining sponsor confidentiality, realigning institutional budgets, and restoring site trust through HCP engagement.
  • Positioned Turkey among the top-enrolling countries in a global study despite early operational setbacks.
  • Designed multi-year SC budget plans aligned with enrollment timelines and protocol task modeling.
  • Directed B&C teams to apply institution-specific budget structures within sponsor limits.
  • Oversaw long-term FTE projections to ensure staffing continuity and trial efficiency.
  • Led cross-functional alignment with clinical ops, regulatory, startup, finance, and medical affairs to meet study milestones.
  • Mentored ~20 CRAs across 6 trials through protocol-specific refreshers and SC oversight modules.
  • Facilitated learning forums with 40+ site-facing personnel in Turkey covering RBM, retention, and operational standards.
  • Created team engagement programs to build cohesion, psychological safety, and shared ownership.
  • Managed SC–PI–CRA relationship conflicts via discreet mediation, ensuring trial continuity and care quality.
  • Maintained ethical neutrality during sensitive PI budget discussions, focusing on institutional equity and compliance.
  • Honored with the Eli Lilly President’s Award for excellence in milestone delivery, oncology performance, and leadership.

Senior Site Manager

ICON Plc (FSP for Janssen)
03.2022 - 11.2023
  • Managed end-to-end site operations for Phase II–III trials in Immunology and Infectious Diseases portfolios, supporting study execution from site initiation through close-out across Turkey.
  • Designed and implemented patient engagement strategies that improved enrollment velocity and minimized screen failure rates, especially in high-burden therapeutic areas.
  • Monitored site performance against key milestones and proactively identified deviations, leading to early interventions that reduced protocol deviation risk.
  • Conducted feasibility assessments and PI engagements during pre-selection, contributing to the onboarding of high-performing sites aligned with study goals.
  • Led SC/CRA onboarding for newly opened sites, providing tailored coaching and practical training to ensure protocol adherence and patient safety compliance.
  • Partnered with medical science liaisons and clinical teams to optimize patient journey and site readiness prior to each major study milestone.
  • Served as primary point of contact for PI and site staff during site activation crises, helping resolve B&C bottlenecks, shipment delays, and data query escalations.
  • Actively contributed to process improvement feedback loops by identifying site-level workflow inefficiencies and collaborating with sponsor teams to co-design corrective strategies.
  • Oversaw documentation and site file completeness in line with GCP and sponsor SOPs, achieving audit-readiness status across all assigned sites.
  • Supported cross-country knowledge exchange by mentoring junior monitors and contributing to internal Janssen/ICON alignment forums on best practices and regional trends.

Clinical Research Associate II

Labcorp
03.2021 - 03.2022
  • Monitored Phase II–IV studies across Hematology (Hemophilia, Gaucher Disease, MM), Pulmonology (Asthma, COPD), and ENT (Rhinosinusitis), ensuring protocol adherence and regulatory compliance.
  • Served as RBM Subject Matter Expert (SME), training CRA teams and supporting risk-based implementation at PI-initiated trial sites.
  • Supported study startup and risk-based monitoring at a PI-initiated, RBM-supported trial site, facilitating site readiness, system setup, and operational alignment with sponsor expectations.
  • Consistently exceeded patient recruitment targets, achieving 121% enrollment across assigned studies through proactive site engagement and patient retention strategies.
  • Led SIV, IMV, and COV visits independently; supported database lock and interim analyses through timely query resolution.
  • Mentored junior CRAs during site transitions and contributed to CRA onboarding on GCP, protocol training, and clinical systems.

Clinical Research Associate

Clintec
09.2019 - 03.2021
  • Monitored Phase II–IV trials across Oncology (lung, breast, gastric, urothelial) and Anesthesia, managing all CRA activities from SIV to close-out.
  • Served as Shared Investigator Platform (SIP) and Clinical Supply SME, training site staff and supporting digital platform implementation.
  • Designed site-specific forms and data collection tools, reducing source data errors and improving query resolution rates.
  • Acted as the first onsite monitor during the COVID-19 pandemic, ensuring protocol continuity under emergency conditions.
  • Achieved 118% patient recruitment across assigned trials by implementing proactive retention strategies.
  • Led protocol training sessions and GCP briefings for site staff and newly hired CRAs, promoting protocol adherence and site readiness.

Clinical Research Site Initiation Coordinator

Atlas CRO
11.2016 - 08.2018
  • Acted as Lead Coordinator for Phase III lung cancer trials under PI Prof. Mustafa Özgüroğlu, managing end-to-end trial execution and high-quality data capture.
  • Supported clinical trial operations in Pediatric Hematology protocols, training naive investigators and site staff on protocol adherence, GCP, and documentation standards.
  • Facilitated subject enrollment and retention through proactive patient engagement and visit coordination, contributing to consistent recruitment performance.
  • Collaborated with study monitors and sponsors to resolve site-level queries and optimize source documentation quality.

Project Assistant

PPD Global
04.2018 - 07.2018
  • Acted as Global eTMF Subject Matter Expert (SME), ensuring accurate trial master file management and regulatory compliance across multi-country studies.
  • Led document QC activities for the Turkey office and trained new project assistants, promoting SOP adherence and audit preparedness.
  • Managed Payments SME responsibilities in absence of a local finance unit, ensuring timely and accurate investigator reimbursements.
  • Supported multiple sponsor audits and contributed to FDA site inspection preparation, maintaining documentation integrity under regulatory scrutiny.
  • Coordinated communications between sites, sponsors, and ethics committees during startup, supporting submissions and site readiness for global Phase III trials.

Research Assistant

Atabay Pharmaceuticals & Fine Chemicals
05.2016 - 11.2016
  • Conducted formulation and validation processes for chemotherapeutic agents in a GMP-aligned environment.
  • Contributed to biosimilar drug research within a TUBITAK/KAMAG-funded experimental biotechnology project.

Lab Assistant

Acıbadem Healthcare Group
09.2015 - 01.2016
  • Assisted in sample processing and quality control within a clinical laboratory, ensuring compliance with biosafety and regulatory standards.
  • Supported lab operations including data logging, equipment calibration, and pre-analysis preparation under supervision.

Education

Master of Science - Molecular Biology And Genetics & Biotechnology

Istanbul Technical University
İstanbul
06-2017

Bachelor of Science - Biology

Istanbul University
İstanbul
06-2015

Skills

  • Clinical Trial Management (Phase I–III)
  • Feasibility, Site Selection & Start-Up
  • Regulatory Strategy & Submission Planning
  • Risk-Based Monitoring (RBM) – SME experience
  • CRA & SC Oversight & Training
  • Patient Recruitment & Retention
  • Budget Forecasting & FTE Planning
  • Audit & Inspection Readiness
  • Cross-functional Project Leadership
  • Conflict & Crisis Resolution
  • Document QC, TMF QC
  • Protocol Training Design

Key Therapeutic Areas of Expertise

  • Oncology: Lung Cancer, Breast Cancer, Gastric Cancer, Urothelial Cancer, Cervical Cancer
  • Hematology: Multiple Myeloma, Hemophilia, Gaucher Disease
  • Immunology: Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn’s Disease
  • Endocrinology: Obesity
  • Psychiatry: Schizophrenia, Bipolar Disorder, Alcoholism, Tobacco Use
  • Cardiology: Atherosclerotic Cardiovascular Disease (ASCVD), Heart Failure with Preserved Ejection Fraction (HFpEF)
  • Nephrology: Chronic Kidney Disease (CKD)
  • Respiratory & ENT: Asthma, COPD, Rhinosinusitis
  • Anesthesia: Reversal of Neuromuscular Blockade

Timeline

Clinical Trial Manager

ICON Plc (FSP for Eli Lilly)
11.2023 - Current

Senior Site Manager

ICON Plc (FSP for Janssen)
03.2022 - 11.2023

Clinical Research Associate II

Labcorp
03.2021 - 03.2022

Clinical Research Associate

Clintec
09.2019 - 03.2021

Project Assistant

PPD Global
04.2018 - 07.2018

Clinical Research Site Initiation Coordinator

Atlas CRO
11.2016 - 08.2018

Research Assistant

Atabay Pharmaceuticals & Fine Chemicals
05.2016 - 11.2016

Lab Assistant

Acıbadem Healthcare Group
09.2015 - 01.2016

Master of Science - Molecular Biology And Genetics & Biotechnology

Istanbul Technical University

Bachelor of Science - Biology

Istanbul University

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Ayşe Sinem Demiralp