Iva Ivanova

• Conducted site visits to monitor compliance with study protocols.
• Reviewed clinical trial documents for accuracy and completeness.
• Collaborated with study teams to ensure timely project execution.
• Assisted in training site staff on study procedures and regulations.
• Managed data collection processes to maintain integrity and quality.
• Coordinated communication between sponsors and clinical sites effectively.
• Evaluated site performance metrics to identify improvement areas.
• Supported regulatory submissions by preparing necessary documentation.
• Performed pre-study site evaluations, site initiations, interim monitoring and study close-out visits.
• Reported to project manager for issues related to overall study status.
• Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.
• Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
• Interacted with sponsors, CROs, investigators, vendors and subcontractors as needed.
• Coordinated the submission of regulatory documents to IRBs and ECs and other relevant authorities.
• Prepared reports summarizing study progress and results for senior management review.
• Evaluated proof of eligibility and consent for participants.
• Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
• Maintained strict confidentiality to keep personal information and collected data private.
• Monitored safety events reported during the course of clinical trials in accordance with SOPs.
• Collected and authenticated data collection forms to read and interpret complex clinical protocols.
• Ensured proper storage of investigational product at investigator sites per GCP guidelines.
• Tracked enrollment status across multiple sites to ensure target goals were met in a timely manner.
• Ensured timely completion of all deliverables by tracking project timelines and milestones.
• Attended investigator meetings to provide framework for successful research studies by establishing responsibilities.
• Adhered to good clinical practices, operating procedures and regulatory requirements.
• Coached team members on best practices for conducting effective studies.
• Participated in internal audits related to clinical research operations processes.
• Participated in educational training, activities, and professional development programs.

• Monitoring clinical trials within the Diabetic therapeutic area. Phase III
• Responsible for ensuring the highest possible quality of data obtained in clinical trials by managing trial sites in accordance with the trial protocols, the local legislation, Company policies, SOP’s and ICH GCP requirements.
• Performing monitoring functions to assess the progress of clinical studies at assigned investigative sites (either on-site or remotely) to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, ICH GCP guidelines, Company standard operating procedures (SOPs), and all applicable regulatory requirements.

Preparation and conduct of Trial sites initiations and closures. Audit readiness.

• Assisting the Site Start-Up Department in the preparation, compilation, submission and maintenance of regulatory documentation required by local and international regulatory agencies for clinical trials and marketing applications.
• Assisting the Project Team with the day-to-day management of clinical studies as required. Providing functional assistance to the Project Team and Clinical Team members with administrative, logistical and practical issues, including the tracking, collection, distribution and filing of study documentation.
• Governing high quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting, compliance with objectives, and co-operation with other team members. Ensuring adequate tracking is in place for all activities and reports formatted as required for submission within the agreed timelines.
• Tracking and supervising collection of ongoing study data for purpose of regular project status reporting as required.

• Budget negotiation with Investigators and Institutional lawyers, Contract negotiation with sites and Institutions; Distribution of completed documents; Communication with sites and teams on daily basis, etc.
• Led negotiations on contracts, ensuring favorable terms for stakeholders.
• Coordinated with legal teams to ensure compliance with contractual obligations.
• Advised senior management on various negotiating strategies based on industry best practices.
• Resolved conflicts during negotiations by implementing strategic communication techniques.
• Maintained relationships with key clients to ensure ongoing collaboration and trust-building.

Execution and follow up of payments: SAP general purchaser, Study budget tool management, Single point of contact with the investigators;
Study administration: eTMF & ANGEL, Impact (CTMS) administrator, Document management, Study coordination, Study submissions
Preparation of regulatory documents, Preparation of site-specific documents, including those with sensitive data, Contract management, Feasibility analysis;
Distribution of completed documents, Preparation of submission files to both Regulatory Agency and Ethics Committee for Multicenter Trials; Correspondence with Drug Agency, Local ethics committees and ECMT, etc.
Preparation of ISF’s, Preparation and maintenance of Study Master Files incl. eTMF based; Organization of investigator’s meetings, Organization of shipments to sites, Assistance in recruitment initiatives etc.

• Responsible for the introduction of new products to the market and expanding the reach of the existing products.
• Developed detailed segmentation plans to identify target audiences for marketing campaigns, based on their demographics, behavior, and lifestyle.
• Developed brand strategies to enter the market and/or enhance product visibility in the market.
• Conducted market research to identify potential partners in order to reach the target audience.
• Contacted potential clients, prepared offers, and conducted meetings.
• Negotiated with new partners.
• Initiated activities at field level.
• Developed various marketing campaigns. Recruited and trained promoters.
• Monitored and recorded inventory stock to document use of items.
• Coordinated with external vendors to facilitate delivery of targeted content and ads.

• Developed marketing content according to Samsung's guidelines.
• Request and defense of the marketing budget for Bulgaria.
• Analyzed market trends to identify opportunities for product promotion.
• Reorganization of the selling points for a better consumer experience.