Esma Ok

Esma Ok Email and Phone Number

Project Manager (CSM) @ Ascot Science | Clinical Research & Clinical Trials Management | Clinical Development Processes @ Ascot Science
maslak, istanbul, turkey
Esma Ok's Location
Istanbul, Türkiye, Turkey
About Esma Ok

I began my professional career in the pharmaceutical/health sector in 2002, after graduating from Yıldız Technical University's "Chemical Engineering" department. I worked at Kurtsan as a "Regulatory Affairs Responsible" and subsequently at Kurtsan Medical as a "Product Manager" between 2002-2005. I worked for Sanofi Pasteur outsourced to Manpower, as a "Monitor" for the HAF 65 trial, between 2006-2007, which enabled pursuing my clinical trials career. I ensured that clinical trials were conducted in accordance with international and national standards and ICH-GCP , and I made all essential follow-up and reporting. I worked as a "Clinical Research Associate, CRA" (2007 - 2009) and a "Country Study Manager, CSM" (2009 - 2015) at ROCHE, a global-scale organization that provides solutions in oncology, hematology, virology, dialysis, transplantation, rheumatology, and osteoporosis, between 2007-2015. After the Head of the relevant Department accepted a temporary duty in Egypt, I was chosen from the three CSMs and designated as the "Deputy of Clinical Trials Manager" by proxy.I played a key part in clinical trials and research for various indications such as rheumatoid arthritis, gastric cancer, hepatitis, breast cancer, lymphoma, basal cell carcinoma, dialyzes, during my time in Roche. In my profession, I had the chance to get broad expertise from phase II to IV clinical trials and also post-authorisation studies including planning and publishing. By anticipating difficulties that emerged/may arise in the procedures, I was able to promptly remedy them. I have made a difference in the field I work for by consistently delivering outcomes that exceed the target expectations. If I were to provide a few instances, - Recruiting the first patient in the EEMEA area for the Kamilla MBC trial,- Increasing the target number of patients in Stevie Phase II BBC trial from 5 to 10, Kamilla Phase III MBC trial from 30 to 50, the Gen C HCV study from 200 to 300, making it the third country with the most patients among 30 countries, and increasing the target number of patients in the Pegbase study from 150 to 200, making it the fourth country with the most patients among 27 countries. - 2008, 2009, 2011 and 2014 performance evaluation results; “Exceeded Expectations”For more information please check my Linkedin profile.*****Feel free to connect with me here on Linkedin if you'd like to stay in touch.Contact > esma.ok79@gmail.com

Esma Ok's Current Company Details
Ascot Science

Ascot Science

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Project Manager (CSM) @ Ascot Science | Clinical Research & Clinical Trials Management | Clinical Development Processes
maslak, istanbul, turkey
Website:
ascotscience.com
Employees:
7
Esma Ok Work Experience Details
  • Ascot Science
    Clinical Project Manager
    Ascot Science Nov 2023 - Present
  • Sentez Cro
    Project Manager
    Sentez Cro Sep 2022 - Nov 2023
    Istanbul, Turkey
  • Roche
    Country Study Manager
    Roche Aug 2009 - Oct 2015
    Istanbul, Turkey
    • To provide direction and leadership to Roche CRAs and to manage local CROs• To ensure goals are in line with the operational strategy agreed by clinical and study management teams• To develop and maintain effective business relationships - Key contact person for stakeholders (e.g. pharma business, GSM, functional management)• To oversee the project, protocol, site feasibility and to determine site selection and patient allocation• To establish and maintain accurate study level plans in PlanSource• To develop country-level work timelines and to ensure that milestones are set and managed for overall studies delivery• To develop and manage local CCO budget/financial plan, and to forecast using appropriate tools• To provide appropriate resources for the work to be done on time and within budget (for LSTs)• To select, train and manage external suppliers supporting local CCO | To ensure all local CCO regulatory, ethical, and administrative submissions and approvals | To ensure local CCO studies are performed in compliance with ICH-GCP guidelines, Roche SOPs, local operating guidelines • To ensure monitoring reports are timely, reviewed and to take appropriate actions for follow up on-site issues• To ensure that trial management tracking tools (e.g. CTMS/CTP) and systems are populated and maintained• To lead and/or organize and/or to participate in local or regional meetings and training sessions (LST meetings, Investigator Meetings, Monitor's Workshop, and CRO training, etc.)
  • Roche
    Clinical Research Associate
    Roche Sep 2007 - Aug 2009
    Istanbul, Turkey
    • To manage local CROs | To provide that clinical research is conducted according to international and national guidelines like GCP and ICH Guidelines | To ensure submission of event reports and necessary notifications for local health authorities like the Ministry of Health, local ethics committee | To ensure that reports and records kept at the site are accurate and complete• To provide that research products are stored under appropriate conditions safely• To organize and prepare for monitoring, pre-trial, initiation, and quality control visits• To ensure that trial management tracking tools (e.g. CTMS/CTP) and systems are populated and maintained• To ensure monitoring reports are timely, reviewed and to take appropriate actions for follow up on-site issues
  • Sanofi Pasteur
    Monitor
    Sanofi Pasteur Feb 2006 - Jun 2007
    Istanbul, Turkey
    • Responsible for one of Sanofi Pasteur studies HAF 65 which was outsourced to Manpower• To provide that clinical research is conducted according to international and national guidelines like GCP and ICH Guidelines | To organize, prepare and perform for monitoring visits | To provide necessary notifications to central (Ministry of Health) and local ethics committees• To prepare adverse event reports for local health authorities like Ministry of Health Ethics Committee, İstanbul Providence of Health Directorate, local ethics committee, submit these reports to related authorities and follow up processes• To ensure that reports and records kept in the field are accurate and complete, and research products are safely stored under appropriate conditions | To assist investigators about study procedures
  • Kurtsan İlaçları A.Ş.
    Product Manager
    Kurtsan İlaçları A.Ş. 2003 - 2005
    Istanbul, Turkey
  • Kurtsan İlaçları A.Ş.
    Regulatory Affairs Responsible
    Kurtsan İlaçları A.Ş. 2002 - 2003
    Istanbul, Turkey

Esma Ok Skills

Pharmaceutical Industry Oncology Clinical Development Clinical Trials Gcp Pharmacovigilance Ich Gcp Ctms Infectious Diseases Project Management

Esma Ok Education Details

Frequently Asked Questions about Esma Ok

What company does Esma Ok work for?

Esma Ok works for Ascot Science

What is Esma Ok's role at the current company?

Esma Ok's current role is Project Manager (CSM) @ Ascot Science | Clinical Research & Clinical Trials Management | Clinical Development Processes.

What schools did Esma Ok attend?

Esma Ok attended Yildiz Technical University.

What skills is Esma Ok known for?

Esma Ok has skills like Pharmaceutical Industry, Oncology, Clinical Development, Clinical Trials, Gcp, Pharmacovigilance, Ich Gcp, Ctms, Infectious Diseases, Project Management.

Who are Esma Ok's colleagues?

Esma Ok's colleagues are Beyza Gürler, Huseyin Parlak, Simge Akçora, Merve Uzunoglu, Sinan Kalfa, Onur Güner, N. Alara Sağlam.

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