Denitsa Radeva
Sofia,Bulgaria
Summary
Offering strong organisational and problem-solving skills, with background in coordinating operations and improving processes. Knowledgeable about teamwork, communication, and adaptability, with focus on delivering results and driving improvements. Ready to use and develop analytical, strategic planning, and multitasking skills
Overview
16
16
years of professional experience
2012
2012
years of post-secondary education
1
1
Certification
Work history
Clinical Systems Operations Specialist I
PPD
Sofia
11.2023 - 11.2025
- Guides and supports study teams and site payments team through the creation, activation, and maintenance of the Subject Visit Template/SVT for the study
- Reviews all study related documents such as protocol, budget, payment schedule and Systems Alignment template to determine the best approach to the SVT build and its structure and visit schedule taking into consideration the study design, schedule of events, phases and treatment arms
- Completes SVT amendments due to a protocol amendment and budget amendment – assessing the impact of the SVT amendments on existing subjects and data entered
- Monitoring of the timelines of the new SVT build and amendments to mitigate the risks in case of issues or delays
- Works on Visit Activity Matrix/ VAM requests – Completes VAM requests sent by the SVT review team in a timely manner, created a workaround for easier and faster VAM creation and entry in CTMS
- Assists clinical and site payments team with issues regarding the study SVT and subject tracking and escalates issues to the clinical systems support, if necessary
- Performs quality checks of the work of other team members and provides them with feedback
- Systems Alignment SME – helping clinical and site payments team complete, submit and update the System Alignment Template for the study
BSSO Specialist I
PPD
Sofia
05.2021 - 11.2023
- Provides ongoing support and guidance to ensure that the study teams are able to use the systems efficiently and effectively.
- Identifies risks, issues or concerns and proactively communicates them to the Project Lead.
- Works with the study team and, as necessary, relevant support channels to find solutions to the issues.
- Mentors, supports and trains other team members.
- Participates in initiatives to develop, optimize and improve clinical systems and/or associated support, training and communications.
- Organizes and leads the Subject Visit Template (SVT) Build process within SVT meetings.
- Overseeing the daily activities of a small team ensuring accuracy, consistency, and adherence to established process and timelines.
- Serving as team lead. Assigning and reviewing work within the team, overseeing escalated issues, and mentoring junior team members.
- Reviewing output within the work group to ensure accuracy, consistency, and adherence to established processes, quality standards and timelines.
- Participating in new team members selection, interviewing and onboarding process by attending candidate interviews and providing feedback
Principal CTMS Activation Specialist
PPD
Sofia
04.2017 - 05.2021
- Guides and supports study teams with the creation, activation, maintenance, closure and archival of projects within CRG’s clinical systems.
- Supports study teams with systems alignment, customized template creation, study access management and study maintenance.
- Coordinates and leads meetings with study teams to finalize study creation, activation, closure and/or archival.
- Evaluates risks, issues or concerns raised by the study team, provides recommendations and/or solutions and, as necessary, works with the relevant support channels to ensure they are resolved.
- Mentors, supports and trains other team members.
- Undertakes projects, assignments, and other administrative tasks per business needs including, but not limited to, data entry and data quality review.
Senior CTMS Activation Specialist
PPD
Sofia
04.2016 - 04.2017
- Cooperating with study teams to complete the Systems Names Alignment process
- Reviewing all study related documents to build the MASTER Subject Visit Template for the study
- Leading the Subject Visit Template review and finalization meeting with the project lead and site payments representative
- Leading weekly team review meetings with the team in Sofia office to discuss assignments, workload distribution and issues.
- Performing quality checks of the work of other team members
- Training and mentoring new team members.
CTMS Activation Specialist
PPD
Sofia
10.2013 - 04.2016
- Reviewing study information to effectively customize all study related templates.
- Leading and coordinating CTMS Activation study-related meetings
- Proactively escalating of potential issues to limit their impact and seek satisfactory resolutions.
- Managing accuracy of entered data.
- Recording and acting on CTMS Activation related requests
CTMS Analyst I
PPD
Sofia
10.2011 - 10.2013
- CASCADE and PPD CTMS data entry in a timely manner and in compliance with applicable SOPs/WPDs
- Adherence to QC processes and responding to QC discrepancies in a timely manner.
- Reviewing study information, client reporting needs and project team needs to efficiently develop and customize site Subject Visit Templates in CASCADE
IT Specialist
Alpha Bank Bulgaria
Sofia
01.2010 - 09.2011
- Administration of key banking systems, First level user support, Coordination and escalation of incidents
Education
MSc - Industrial Engineering
Technical University
Sofia, BulgariaBSc - Industrial Engineering
Technical University
Sofia, BulgariaSkills
- MS Office (Outlook, Word, Excel, Power Point, OneNote, Access, SharePoint)
- CTMS Siebel
- Veeva
- Oracle Activate
- Preclarus
- ProjectView
Certification
- PPD EDGE, 2013
- PPD LEAD, 2017
- PPD Lean Six Sigma, 2017
- PPI Business System Power User, 2025
LANGUAGES
Native Tongue: Bulgarian
Proficient: English
Accomplishments
2018 - PPD CEO Defining Principles Award: Game Changer
2020 - PPD CEO Defining Principles Award
Timeline
Clinical Systems Operations Specialist I
PPD
11.2023 - 11.2025
BSSO Specialist I
PPD
05.2021 - 11.2023
Principal CTMS Activation Specialist
PPD
04.2017 - 05.2021
Senior CTMS Activation Specialist
PPD
04.2016 - 04.2017
CTMS Activation Specialist
PPD
10.2013 - 04.2016
CTMS Analyst I
PPD
10.2011 - 10.2013
IT Specialist
Alpha Bank Bulgaria
01.2010 - 09.2011
BSc - Industrial Engineering
Technical University
MSc - Industrial Engineering
Technical University