Canan Elhan
Ankara
Summary
I have approximately 6 years of experience in clinical research and the pharmaceutical industry and I spent last 1.5 year in Amsterdam/Netherlands. Now, as of September 2024, I will relocate again to Ankara/Turkey.
During my time in the Netherlands, in addition to my work experiences in Turkiye, I also gained experience in the sites of Belgium & Netherlands.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Site Contract Manager
Johnson & Johnson Innovative Medicine through Syneos Health
03.2023 - Current
- Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored studies through direct negotiation for sites in Belgium & Netherlands & Turkiye
- Responsible for delivery of established targets/measurements
- Ensure that contractual terms and provisions are following corporate processes, systems, and strategies
- Analyze investigator grants for fair market value aligned with regional knowledge and the J&J grant pricing guidelines, and based on the adequate scope of work, the clinical trial protocol, and other clinical trial information
- Work with the global Contract & Centralized Services team to review and analyze to reach acceptable language
- Assess risks of budget and legal provisions in conjunction with members of the Contract & Centralized Services team and support functions and communicate such to partners
- Privacy, and other partners to acquire guidance and raise issues as appropriate
- Work proactively to improve processes and establish refinements that reduce cycle time, build savings, and improve efficiency in the initiation of clinical trial sites
- Mentor and train new contract coordinators and analysts
- Assume responsibility for all aspects of legal document and metrics tracking
- Resolve potential needs for contract amendments and lead amendment lifecycle
- Outstanding customer focus with a vision to drive solutions
Senior Site Start-Up & Regulatory Specialist
Syneos Health
08.2022 - 01.2023
Site Start-Up & Regulatory Specialist II
Syneos Health
02.2021 - 08.2022
- Responsible for quality deliverables at the country level
- Responsible from CTMS/Activate tracking and Veeva Vault/TMF uploading
- Compiles and/or reviews essential document packages for site activation
- Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval/submissions as required
- Oversees ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country
- Prepares country & site specific ICFs
- Local Site ID and Feasibility Support - Provides support site selection lead and PM/SSUL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial
Sr. Site Management Coordinator / Regulatory & Start-Up Specialist
IQVIA
07.2019 - 01.2021
- Manage of initial submission process based on country specific documents and core pack package from sponsor of the study (including insurance review, patient documents customization, delegation letter review)
- Perform submissions (Initial submission, maintenance submissions including substantial/non substantial amendments, notifications required per country regulation) to the EC and RA related in the assigned projects
- Communicate with local ethics committees and regulatory authority for study queries as single point of contact in Turkey on behalf of global team & sponsor
- Customize and finalized of country specific ICFs for submissions regarding the country specific guidelines
- Perform site specific budget and contract customizations, directly involved in negotiations with sites
- Prepare and collected the essential documents from sites
- Site initiation process with collected Essential Document Pack documents and fully executed Clinical Trial Agreement
- Prepare Study Coordinator Work Orders & Ancillary Agreements with the vendors for site activation
- Provide the site selection letter to the investigators and supported the site ID
- Worked with Quality Management to ensure appropriate quality standards for the duration of the project
Jr. Quality Assurance Specialist
Bilim Pharmaceuticals
05.2018 - 07.2019
- Manage of SAP and artwork process
- Create the packaging material's master data on SAP and prepared their artworks with Graphic, Production and Regulatory Departments regarding the Regulatory Authority guidelines
- Prepare SOPs and installed them on an internal system
- Manage change control process for packaging materials
- Communicate with vendors regarding the quality control department queries related with production materials
Education
Bachelor - Chemistry
Hacettepe University
01.2018
Certification
- The Project Management Course: Beginner to Project Manager, 03/2023
- Good Clinical Practices, 03/2023
- Product Management in Pharmaceutical Industry Program, 05/2019
- Supploer/Manufacturer Audits & Internal Audit Process, 02/2018
- Quality Risk Management & Root Causes Analysis, 12/2018
Languages
Turkish
Native language
English
Advanced
C1
Therapeuticexperience
- Hematology - Anemia, Sickle-Cell
- Immunology / Inflammatory - WHIM Syndrome
- Infectious Disease - COVID-19, Respiratory Syncytial Virus
- Neurology - Multiple Sclerosis, Spinal Muscle Atrophy
- Oncology - Breast Cancer, Lung Small Cell Cancer, Multiple Myeloma, Refractory Solid Tumors, Myelofibrosis
Timeline
Site Contract Manager
Johnson & Johnson Innovative Medicine through Syneos Health
03.2023 - Current
Senior Site Start-Up & Regulatory Specialist
Syneos Health
08.2022 - 01.2023
Site Start-Up & Regulatory Specialist II
Syneos Health
02.2021 - 08.2022
Sr. Site Management Coordinator / Regulatory & Start-Up Specialist
IQVIA
07.2019 - 01.2021
Jr. Quality Assurance Specialist
Bilim Pharmaceuticals
05.2018 - 07.2019
Bachelor - Chemistry
Hacettepe University
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