Tugba Diken Cetin
Study Start‑Up Head
Istanbul
Summary
Collaborative leader partners with coworkers to promote engaged, empowering work culture. Motivated, innovative and customer- and people-focused clinical research leader with nearly 16 years' experience in pharmaceutical companies and global CROs, specializing in study start-up and clinical operations. Established and led country start-up functions across Turkiye, Saudi Arabia, Lebanon, Algeria and Morocco, building and managing multidisciplinary teams (feasibility manager; contract & budget manager; finance CTA; contract specialists; start-up specialists; import specialists) and providing line management for 20+ staff. Proven expertise in regulatory and ethics submissions, CTA dossier preparation, contract and budget negotiations, site feasibility, selection and activation, vendor and partner CRO management, eTMF oversight and local regulatory training. Track record of driving process improvements and operational efficiencies, including 63% reduction in submission timelines, 40% reduction in Health Authority approval timelines and 48% reduction in First Patient First Visit timelines. Holds dual BSc degrees in Food Engineering and Chemistry from Istanbul Technical University.
Overview
16
16
years of professional experience
6
6
Certifications
2
2
Languages
Work History
Study Start-up Head/ Study Start-up Manager
NOVO NORDISK
05.2023 - Current
- Established and led the CDC Turkey start-up function covering Turkiye, Saudi Arabia, Lebanon, Algeria and Morocco; recruited, developed and executed country-specific start-up strategies; managed start-up budgets, timelines, quality and risk to ensure timely site activations.
- Chaired periodic trial meetings, tracked country-level issues and implemented mitigation plans; led improvements to submission, contract, informed consent, import and translation processes.
- Reduced submission timelines by 63%, reduced Health Authority approval timelines by 40%; reduced First Patient First Visit timelines by 48%; improved informed consent, import, payment, feasibility and contract processes to accelerate site activations and approvals.
Sn Clinical/Site Intelligence & Activation Manager
PPD (Part of Thermo Fisher Scientific)
06.2020 - 04.2023
- Led country start-up operations by ensuring timely completion of feasibility, site selection and activation milestones for Turkey.
- Managed, hired, trained, resourcing, coached and managed performance of clinical staff (Country Approval Specialists, Contract Specialists, Clinical Research Associates, Clinical Trial Coordinators).
- Acted as primary country contact for start-up activities in Turkey; provided local expertise for site activation and coordinated technical risk resolution with contract, regulatory, PV and clinical ancillary teams.
- Oversaw vendor management for site coordinator activities and liaised with clients on issue resolution and project oversight.
Assoc Mg/Manager, Clinical and Start-up Operations
Fortrea (formerly Labcorp Development, Covance)
07.2016 - 05.2020
- Led country start-up operations by ensuring timely completion of feasibility, site selection and activation milestones for Turkey, Greece and Middle East Countries.
- Provided line management and support to CRAs and local start-up teams across Turkey, Greece; managed Middle East countries through partner CROs for start-up service delivery.
- Coordinated with Contract Managers, Global Regulatory Submission Specialists, PV, Clinical Ancillary Supply and other stakeholders to ensure alignment with critical path for site activation.
Global Site Services Specialist II
Fortrea (formerly Labcorp Development, Covance)
01.2014 - 06.2016
- Prepared and coordinated local regulatory submissions (MoH, EC and other national applications), Investigator Packages and site-specific patient information/informed consent documents.
- Managed site contract finalization, investigator grant budgets, payment schedules and ancillary agreements.
Regulatory and Site Start-up Coordinator/Assoc. Spec./ Specialist
IQVIA (formerly Quintiles)
02.2010 - 01.2014
- Prepared and coordinated local regulatory submissions and site start-up activities; acted as primary contact with investigators and local regulatory authorities; aligned submissions with critical path for site activation.
- Developed country and site-specific patient information sheets/informed consent forms and coordinated site contracts and related documents.
Education
BSc - Food Engineering
Istanbul Technical University
06.2009
BSc - Chemistry
Istanbul Technical University
06.2008
Skills
Team leadership
Certification
Leadership Journey, Novo Nordisk, 2024
References
- Asude, Ademogullari, Director, CDC Turkiye, asua@novonordisk.com, +90 533 714 63 72, Novo Nordisk
- Helene, Meytraud, Regional Director Southern EMEA & Africa, hmeytraud@aol.com, +33 660 10 01 82, PPD
- Seniz, Sagol Tuysuz, Clinical Research Executive, senizsagol@gmail.com, +90 530 391 39 41, Evideep
Accomplishments
- 30% and 63 % faster submissions in 2024 and 2025
- 25% and 40% reduction in HA approval timelines in 2024 and 2025
- 48% faster First Patient First Visit (FPFV)
- 65% of sites ready for site activation at First Patient First Visit (FPFV)
- Implementation of umbrella and single site contract templates to accelerate start-up
- Increased quality in submission packages supporting approval timelines positively
- Increased oversight in import export process supporting activation process
- Maintained strong relationship with internal and external stakeholder (Health Authority, Ethics Committees)
Timeline
Study Start-up Head/ Study Start-up Manager
NOVO NORDISK
05.2023 - Current
Sn Clinical/Site Intelligence & Activation Manager
PPD (Part of Thermo Fisher Scientific)
06.2020 - 04.2023
Assoc Mg/Manager, Clinical and Start-up Operations
Fortrea (formerly Labcorp Development, Covance)
07.2016 - 05.2020
Global Site Services Specialist II
Fortrea (formerly Labcorp Development, Covance)
01.2014 - 06.2016
Regulatory and Site Start-up Coordinator/Assoc. Spec./ Specialist
IQVIA (formerly Quintiles)
02.2010 - 01.2014
BSc - Chemistry
Istanbul Technical University
BSc - Food Engineering
Istanbul Technical University