Dušan Nešić
SSU Manager I MPharm I PhD Student
Novi Sad
Summary
A SSU Manager and PhD student with a long-term goal of a dual career in academia and industry. More than 3 years of experience in clinical trial planning, regulatory compliance, and CTIS management. Previously a CRA, Site Activation Coordinator, and Start-Up Associate, ensuring seamless trial execution. Authored two student research papers and is second author of a published study in the European Journal of Drug Metabolism and Pharmacokinetics. As a scientific section manager at the Medical University of Novi Sad, oversaw student research and conducted quality control prior to professor reviews
Overview
3
3
years of professional experience
1
1
Certification
3
3
Languages
Work History
SSU Manager (Sr Initiation CRA)
Parexel
07.2024 - Current
- Gathered and compiled essential documents from multiple stakeholders to enable timely site initiation
- Engaged with Regulatory Affairs and Clinical Trial Management to plan Clinical Trial Applications (CTAs) for EU countries
- Managed EUCTD/R reporting and ensured accurate data entry in Clinical Trial Information System (CTIS) per EMA regulations.
- Prepared and submitted Institutional Review Board (IRB) applications
- Tracked key study milestones (Start, Completion, Enrollment) and maintained alignment across participating EU Member States
- Supervised vendors managing Clinical Trial Application (CTA) data within the EMA CTIS database
Sr Site Activation Coordinator
IQVIA
07.2023 - 07.2024
- Prepared, reviewed, negotiated and managed Site regulatory documentation and clinical trial agreements with Sites and Sponsors
- Served as the primary point of contact for investigative Sites and/or Sponsors
- Ensured tracking completion of all regulatory and contractual documents for Sites
- Ensured all Site activation activities are performed in accordance with all regulations, SOPs, Work Instructions and project requirements either at the global, regional, or country level and all relevant documents are submitted timely to the Trial Master File as per IQVIA/Sponsor requirements
- Participated in the broader Global Site Activation planning process; contributed to long-mid range goals and plans; and coordinated activities with other managers and their respective sub-families
- Supported the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information
Clinical Research Associate (CRA)
Accelsiors
10.2022 - 07.2023
- Study starts up activities (support with Site selection processes, collecting the essential documents, EC/CA submission packages)
- Performed Site Selection Visits
- Study initiation activities (Completed and recorded Study specific trainings, preformed the Site Initiation Visits etc.)
- Performed Interim Monitoring Visits according to Clinical Monitoring Plan, review AE/SAE, SDV and reporting in timeframe, frequent updates of TMF)
- Study close out activities (ensure timely queries resolution on site, ensure final accountability, performed on Site close out visits, etc.)
Start-up Associate
Accelsiors
11.2021 - 10.2022
- Complied with the Quality Management Systems
- Worked with the Study Start Up Manager on developing study specific strategic plans according to Sponsor contractual and internal timelines, milestones, and team needs.
- Assisted Study Start Up Managers with and participated in sponsor KOM
- Created, maintained/tracked, and obtained approval on essential study start up documents
- Adhered to start up timelines set forth by the Manager of Study Start Up.
- Attended and participate in internal and external calls, as well as developed agendas and circulated meeting minutes.
- Established, maintained and delivered Sponsor/CRO, Central Lab/Supplies communication as well as actions, decisions, and issues.
- Developed and implemented internal process improvement initiatives as applicable. Point of contact for internal and external staff throughout the start up process
Education
Ph.D. - Pharmacy
University of Belgrade - Faculty of Pharmacy
Belgrade, Serbia 04.2001 -
Master of Science - Pharmacy
Medical Faculty Novi Sad
Novi Sad, Serbia 04.2001 -
Skills
Team leadership
Operations management
Strategic planning
Decision-making
Performance management
Time management
Project management
Relationship building
Documentation and reporting
Certification
CRA Academy
Hobbies
Playing and following various sports, including tennis, padel and football. In love with nature and outdoor sport such as hiking.
Timeline
SSU Manager (Sr Initiation CRA)
Parexel
07.2024 - Current
Sr Site Activation Coordinator
IQVIA
07.2023 - 07.2024
Clinical Research Associate (CRA)
Accelsiors
10.2022 - 07.2023
CRA Academy
10-2022
Start-up Associate
Accelsiors
11.2021 - 10.2022
Ph.D. - Pharmacy
University of Belgrade - Faculty of Pharmacy
04.2001 -
Master of Science - Pharmacy
Medical Faculty Novi Sad
04.2001 -
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