Sevda Demireva

• Onboard and manage staff in TMF Hub in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning and directing work, assessing performance and guiding professional development, addressing issues and resolving problems.
• Participate in the selection for hiring new employees by participating in the interviewing process. Ensure new staff are properly onboarded and trained on TMF tasks.
• Participate in the allocation of resources by assigning staff to TMF tasks in clinical studies based on their experience and training.
• Monitor TMF KPIs and internal productivity targets.
• Develop comprehensive training programs to enhance staff skills and improve TMF quality,

• Successfully managed multiple projects simultaneously by providing TMF Quality oversight, KPI analysis and Records Management expertise according to urgency, resource availability, and alignment with organizational goals.
• Served as primary point of contact for internal and external customers with regards to TMF activities.
• Managed a dedicated team of specialists with various roles upon agreed timelines.
• Participated in audit and inspection preparation, conduct and follow-up activities.
• Participated in implementation of plans and resource projections for the assigned studies.
• Primary point of contact for budget discussions and projections within the functional area.

Additional activities:

• Resourcing Manager for different projects, participated in development of resourcing strategies which meet current and future organizational needs.
• Provided mentor and onboarding support to peers new to the role.

• Supported the delivery of accurate and robust site strategies (including, but not limited to Requests for Proposals, awards and re-strategies).
• Mapped country, site and patient's capacity in appropriate geographic areas and contributed to the country, site and patient development strategy to support the company pipeline.
• Contributed to the process improvement to deliver quality and consistency.

• Participated in eTMF setup, maintenance, adherence to milestones, close out.
• Monitored reports on eTMF quality, completeness and timeliness with close collaboration with study teams.
• Supported audit and inspection readiness and GCP compliance throughout the study tenure.
• Assisted in development and monitor of study metrics to highlight deficiencies and suggest process improvements.

• Performed comprehensive TMF quality reviews as per applicable SOPs and customer requirements.
• Provided final quality check of the documents finalized in eTMF
• Identified missing documents by performing applicable cross-checks and co-dependency checks

• Elaborated and disseminated the company mission to partners and clients
• Implemented sales strategies and promotional activities
• Collaborated with Customer care to create and maintain long-term partnerships
• Maintained and expanded customer database

• Arranged and performed presentations to physicians and pharmacists
• Maintained positive working relationships with clients
• Reached and if possible exceeded sales targets

• Planned and implemented marketing, communication and PR strategies
• Managed media relations
• Organized events
• Developed and coordinated medical tourism partnerships
• Developed short- and long-term plans and budgets for marketing activities