Saida Kadyrova MD, PhD, MBA

• Exercised leadership capabilities by successfully motivating and inspiring others.
• Provide training for the big group of cosmetologists and individual training in the following areas Botulinotherapy, treat migraine with BTA, Aesthetics medicine, Injectioans augme with filler, mesotherapy and other injectable practice

• Responsible for leading, developing, supporting and providing direction to Study Management and Operations (SMO) personnel for project, TA/scientific/technical, and operational related issues to enable delivery of drug projects and non-drug projects. Accountable for resourcing SMO members on study teams to support delivery of clinical programs. Responsible for embedding consistent ways of working across Hubs and building SMO capabilities.
• Managing and coaching CTAs, GSAMs, GSLs, PrGSLs
• Leadership of group work and building a team spirit, including developing team style and behavior
• Organize and chair a monthly project review meeting in SMM China
• Ensuring adequate resources for the studies assigned
• Development and performance management of direct reports
• Ensure that the everyone in the team or direct reports have development and training plans, according to IDP process
• Contribute to high quality feasibility work
• Contribute to the quality improvement of the study processes and other procedures.
• Plan and organize coaching of the team members and all direct reports
• Ensure that the individual performance planning and review process is completed for all direct reports
• Prepare salary and bonus proposals of all team members or direct reports based on their performance in close collaboration with responsible SMM Director and HR partner.
• Assist SMM Director or Local Study Leader/teams in forecasting study timelines, resources, recruitment, study materials and drugs.
• Provide direction to LSL/teams on major study commitments including resolving any key issues identified.
• Perform necessary accompanied site visits for direct reports, supporting ongoing coaching and development.
• Support SMM region in initiatives/activities as agreed with SMM Director(s).

Associate Director Global Site Monitoring and Management since 1 October 2018

Associate Director Clinical Research – since 1 October 2017

Senior Clinical Research Manager - Since May 25, 2012 till 31 September 2017

Clinical Research Manager-since January 1,2010 till 25 May 2012

• Responsible for planning and execution International clinical trials in Russia and CIS (Belarus, Georgia and Ukraine), (phases I-II, III, IV) in the field of Hematology, Oncology, Inflammation & Immunology and Local studies.
• Support with clinical trials oversight activities in Russia, Belarus, Bulgaria, Bosnia/Herz, Georgia, Lithuania, Estonia, Latvia, Moldova, Ukraine
• Manage in-house studies from start up phase to close out activity and CRO oversight for CRO conducted trials Russia and CIS country (Belarus, Georgia and Ukraine, ) . Supports CRO oversight trials conducted trials Latvia, Estonia, Lithuania, Moldova, Croatia, Romania, Bulgaria, Serbia, Bosnia and other EU Eastern Europe countries.
• Upon SMs request support with other EU countries such as and others
• Conduct assessment visits and co-visits; Site Health Checks with CRO CRAs and in-house CRA in Russia, Ukraine, Belarus, Georgia, Latvia, Lithuania, and Estonia, Greece
• Quality File Check review of the following countries: Australia, Czech republic, Greece, Italy, Israel, Turkey
• Assessment visit with in-house CRAs and CRO CRAs
• Support in conduction of IITs and NPP (Named Patients Program).
• Support to the Marketing department in preparation for AdBs
• Communication within the company: contribute on Business goals together with marketing and sales team; implement Business plan developing Clinical trials activities
• Interaction with patient organizations

CRA management

• Hire and mentor clinical research staff to ensure project timelines are met. Conduct performance reviews and ensure personal and professional growth of staff. Approve CRO CRAs for outsource studies.
• Managing and coaching of in-house CRAs in various aspects of management that are relevant to particular project issues.
• Planning and supporting the meetings and work of the various groups and bodies associated with the trial.
• Work with trial sites to ensure expedient patient recruitment in conjunction with CROs.
• Partner with Clinical Development to identify investigators and clinical experts that support compound development.
• Work with the commercial team to ensure clinical support and regional activities are in alignment with corporate objectives.
• Communicate on a regular basis with management and study teams information on the emerging standards of care, changes in the therapeutic area and needs of clinicians in the community.
• Management of the clinical monitoring group to assure adherence to high quality GCP standards.
• Assist in vendor identification, negotiate contracts with vendors.
• Manage outside CROs and consultants.
• Manage, track and administer local trial budgets, FTE requirements, and schedules with responsibility for cost, time and quality of clinical trial activities.
• Manage the budget for clinical trials. Have responsibility for the financial management of the clinical trial programme including budget planning, resource allocation.
• Interface with development operations personnel to ensure timelines are met, conflicts resolved and trials are on time and on budget.
• Preparation and participation of the Local Investigator Meetings; International trainings for Investigators
• Work with the commercial team to ensure clinical support and regional activities are in alignment with corporate objectives.
• Communicate on a regular basis with management and study teams information on trainings for Investigators.
• Participation at AIPM meeting; Medical Director and Clinical Research meeting
• Training of sales and marketing representatives at cycle meetings.

Quality Management function at the affiliate level - January 2010-March 2017; December 2017-Feb 2018, mentor for QC Manager Feb 2018 till now

• Establish QMS in the Russian affiliate
• Execution and oversight of SOPs and WPs at the affiliate level, training needs for employees in Russian affiliate
• Affiliate Managing, developing, updating and implementation of the MAF and ClinOps departments SOPs and WPs. This includes training of responsible individuals within and across departments.
• Provide training on GCP and Inspection Readiness for local staff.
• Support in preparation to the audit
• CAPA resolution
• Monitoring of Local Regulation in Russia, Ukraine, Belarus, Georgia, Latvia, Lithuania, and Estonia.
• Implement training programmes for CRAs and other Medical affairs staff.

Drug Safety Manager Back up for the since January 2010 till 2013

Fully trained

• Undertake the notification of adverse events to Celgene International
• Report expedited ADR reports to local regulatory agency as required by local regulations
• Obtaining follow up information for all adverse events received
• Maintaining a tracking system for all adverse events
• Ensure compliance with local regulatory PhV requirements and with Celgene’s internal requirements
• Maintain up to date knowledge of local PV requirements and ensure this information is provided to Celgene International
• Management and supervision of Clinical Safety Specialists.
• Liaise with CROs and other external partners as necessary to ensure Celgene fully meets its Regulatory requirements in respect of case receipt and expedited reporting

Medical Affairs functions during maternity leave of RML Jan 2010 till Oct 2010.

• Med info request and responses
• IIT and Local Studies
• NPP (Named Patients Program).
• Training for the sales force during Cycle meeting
• Cooperation with KOLs
• Interaction with patient organizations

June 2009 – December 2009

Country Research Manager

with function of Process Improvement Coordinator (Quality Manager); Local trainer and Country Capacity Resource Planner

• Management of 10 International Clinical Trials Phase II, III, IV trials in the following therapeutic areas ( Transplantology; Urology: Oncourology; Antiinfection) in Russia, Ukraine and Belarus
• People management and coaching. -9 direct subordinators (Cluster Study Managers, Senior Clinical Research Associates; Clinical Research Associates I and II level, Drug Safety Officer and Clinical Trial Assistant). Supervise and review staff activities, staff appraisals, evaluates, manage and conduct training. Participation in creation of employers’ career plan. Developing job descriptions for all clinical research positions.
• Full management of the clinical trials from start up activities to close out activities of the study.
• Hire and mentor clinical research staff.
• Coordinate and manage clinical operations to ensure the quality, timeliness and accuracy of studies in accordance with written protocols
• Set study timelines and take action to ensure the timely completion of studies as needed
• Participating in study planning and set-up activities including vendor management, project management, and coordination of study and implementation plans
  Supporting vendor relationships; site selection; site feasibility
• Coaching of CRAs in various aspects of management that are relevant to particular project issues.
• Implement training programmes for CRAs and other clinical staff with topics that include: principles and practices of project management, team communication, computer software, protocol and CRF writing, adverse event reporting and the importance of pharmacovigilance, and budget control and reporting, etc.
• Provided ongoing training and support to the clinical team through regular team meetings and communication.
• Ensure effective follow-through on all assigned tasks as well as strategic delegation of tasks to qualified individuals.
• Perform co-monitoring visits
• Develop and writing local WPs and SOPs, forms, and processes to facilitate efficiency and high quality work

Cluster study manager and Process Improvement Coordinator; Local trainer

Clinical trial management as a Cluster study manager

People management and coaching -5 direct sub-ordinators: 3 Clinical Research Associate and 1 Clinical Trial Assistant and , Drug Safety Officer.

Management of 5 International Clinical Trials in Russia, Ukraine and Belarus

• Urology, phase III, 20 site’s, 240 patients
• Urology, phase III, 20 site’s, 240 patients
• Urology, phase III, 14 site’s, 165patients
• Urology, phase III, 14 site’s, 165 patients
• Urology, Phase IV; 10 site’s; 100 patients

Full management of the clinical trials from start up activities to close out activities of the study.

People management:

• Participates to recruitment interviews for Clinical Research Associate (CRAs) and Clinical Trial Assistants (CTAs);
• Trains new staff members on internal procedures and trial protocol
• Contributes to the continuous improvement of the Clinical Research Team
• Regular control of the monitoring activities, timely review and approval of monitoring reports, co-monitoring visits with Clinical Research Associate.
• Perform co-monitoring visits

Trial management:

• Participate in trial planning and set-up activities including vendors management
• Provide training for the international investigators during International Investigators meetings
• Coordinates trial and site feasibility process and gives feedback to Headquarters for international trials
• Prepare and negotiate with Headquarters the Trial Agreement including the costing templates
• Contributes and coordinates preparation and conduct of CRAs meetings and Investigators meetings
• Coordinates start-up activities including clinical trial submission to the Main Ethics Committee, Local Ethics Committees, Primary Care Trusts, Research and Development offices and other relevant boards. Liaise with Regulatory Department for activities related to submission to Competent Authorities
• Keep the trial within the given timelines and budget
• Ensures quality of all steps during preparation, conduct and closure of the clinical trial by following the currently approved protocol/amendment, SOP, GCP/International Conference on Harmonisation Guidelines and other regulatory requirements
• Supports preparation and quality control of clinical trials

Process Improvement Coordinator (PICO)/ Local trainer

• Authors and keeps updated the SOPs and WPs
• Train the New Staff as - company procedures, different company and study program Shared learning session for CRA’s.
• Provide training to medical department employees on new SOPs
• Provide study- and GCP-specific training to investigators during International Investigators meeting, monitors and/or relevant Company staff.

• Monitored practice budget closely to prepare financial reports for monthly board of directors meetings.
• Researched industry innovations and emerging treatments to improve care delivery.
• Treated patients suffering from strokes, brain disorders, and traumatic brain injuries.
• Diagnosed and treated patients suffering from chronic conditions.
• Monitored post-operative recovery and educated patients on at-home recovery.
• Consulted with referring physicians on cases involving disorders and conditions of nervous system.

The competitor of a scientific degree (PhD)

Theme of PhD work: Scientific basis of formation and realization Rehabilitation programs affected by an accident at work

Clinical Research Associate

With function of Clinical Research Physician since January 2007-March 2008

• Award of CRA of the quarter 2006
• Coaching new employees concerning local SOPs, protocol, internal procedures, shared learning session, co-monitoring (Mentor for new employees);
• Prepare presentations for Medical Department meeting, team and investigators meeting.

Description: Management of Clinical Trials

Full management of the clinical trials from start up activities to close out activities of the study.

• Protocol design development and writing
• Preparation of ICD, ICD amendment, ICD summary of changes
• CIB summary of changes preparation
• Active involvement in Protocol design for Local Gastric cancer study.
• CRF design development for local study.
• Analyze and calculate budget for country
• sites selection, feasibility
• IRB and Regulatory study submission, Interim and annual report preparation
• Letter of Agreement and Amendment to the Contract with institution preparation and signing (including all exhibits),
• ontract with distributor companies preparation and signing for marketing drugs other CT-materials/equipment purchase locally
• start-up meeting and annual investigators meetings logistic, arrangement and conducting
• full study logistics (including study drugs, other CT-materials import; biological samples)
• sites initiation, sites monitoring accordingly a monitoring plan and monitoring procedure,
• sites support in CRFs and eCRF’s (EDC) completion and queries answering resolution process
• business contacts with Product/Project Teams, strict adherence to their requirements and a fixed timeline, implement a new monitoring procedure,
• study drugs accountability and final reconciliation,
• interim/final study data locks active participation, close-out visits preparation and conducting,
• Organize and conduct investigator trainings
• Clinical trial record binder cross files check in oncology areas of clinical trials,
• Payments for sites (Act of acceptance preparation for sites etc)

• Neurologist in the neurology department,
• Co-investigator in clinical trials since 2003-2005 phase II, phase III, phase IV, post-marketing research program, IIT. (Alzheimer disease; Parkinson disease, Epilepsy, multiple sclerosis)
• Protocol design development and writing for IIT “Cognitive disorders”
• Scientific work related to the Cognitive disorders
• Organization of local congress with international speaker involvement
• Teamed with other physicians, specialists, and health care providers to provide well-rounded care for complex cases.
• Identified serious conditions and emergency situations and immediately referred to hospital for prompt care.
• Thoroughly examined patients and elicited medical history data to use in assessing health and identifying conditions.
• Engaged with other professionals to impart knowledge and discuss best treatment courses.
• Diagnosed and treated patients suffering from chronic conditions.
• Participated as monitoring physician in clinical trials of medications and treatments.
• Treated patients suffering from strokes, brain disorders, brain cancer and traumatic brain injuries.
• Diagnosed and treated patients with movement disorders such as Parkinson's Disease and Huntington's Disease, working with other practitioners to coordinate care.

Moscow Academy National Economy and Public Administration

Certificate of Oncologist valid 5 years

• Completed professional development in Oncology

Moscow Academy National Economy and Public Administration

Certificate of Neurologist valid 5 years

• Completed professional development Neurology

Moscow Academy National Economy and Public Administration

• Professional development completed Cosmetology

Russian Academy of State (Public) Service at the President of the Russian Federation 2006-2009

State and Municipal Management

The diploma with distinction

Moscow International Higher Business School

2006-2009

Master of Business Administration

(MBA) Management of the international business

The diploma with distinction

Federal Bureau of Medical and Social Expertise of the Ministry of Health and Social Development of the Russian Federation

2005-2008

PhD (The competitor of a scientific degree of the candidate of medical sciences)

CIENTIFIC BASIS FOR THE FORMATION AND IMPLEMENTATION OF THE PROGRAM OF REHABILITATION OF THE INJURED DUE TO AN INDUSTRIAL ACCIDENT

12 publications

Russian State Medical University, at "Russian Cancer Research Center

Blokhin " 2006

Certificate of Oncologist

2003-2005

Clinical Residency in Neurology at the State Hospital.

Do clinical and scientific work. Do clinical trials as sub-investigator

State Medical University of Ryazan under name of Pavlov

2002-2005

management

education 1997-2003

Diploma with Distinction