Ilian Ivanov
MD
Summary
Productive Clinical Operations Manager with highly developed skills in program development and people, implementation and oversight. Superior oral and written communication talents to develop effective clinical policies and procedures. Culturally sensitive and aware of diversity with over 20 years of CRO experience.
Overview
26
26
years of professional experience
1
1
Certification
Work History
Senior Clinical Operations Manager Balkan Region
Easthorn Clinical Services in CEE
9 2012 - Current
- Drives EastHORN geographical expansion and growth in the Balkan Region
- Manages staff in the region to ensure clinical staff works efficiently, while meeting quality and timeline requirements.
- Commits to the company-wide initiatives
- Manages clinical resourcing for the assigned region
- Responsible for local vendor management
- Responsible for external subcontractors management in Balkan Region
- Assists in administrative management of EastHORN office
- Supervise project work
- Support Business Development activities
Director Clinical Operations
INC Research (post acquisition of Kendle International)
2011.10 - 2012.09
- Support of CNS business unit with proposals – review of clinical operations budgets and clinical operations input into country selection and study considerations where appropriate.
- Assignment of LCRAs to proposals and on-going study LCRA needs.
- Interface with other Business Units regarding resourcing to or from other BUs when needed, transfers of resources, oversight of cross BU study assignments
- Manage staff in accordance with organization's policies and applicable regulations
- Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems
- Approve actions on human resources matters.
- Direct the hiring and selection process for country or office and works collaboratively with senior management to set targets for recruitment and retention across roles.
- Establish methods to develop and evaluate office based on-boarding processes
- Develop standard processes to ensure that staff has the proper materials, systems access and training to complete job responsibilities
- Oversee the execution of the training plan, SOP review and mentored training experiences for a region/office/country.
- Provide a leadership role in country/region clinical resourcing process through continual evaluation of existing and future resource alternatives, pro-active planning and collaboration with study team leadership and operational peers.
- Evaluate the quality of the clinical work product for a variety of job roles and/or a specialized job function
- Evaluate regional workload, quality and budget metrics through regular review and reporting of findings
- Collaborate with senior management and other functional leadership to improve efficiencies, project outcomes and quality metrics for clinical projects.
- Act as a coach and mentor for line managers, Clinical Study Managers (CSMs) and Clinical Study Director (CSDs) as they develop in their role
- Work collaboratively with project leadership including the PM, client representatives and other functional leadership to manage project related challenges and to achieve exemplary customer service.
- Analyze and reviews budgets for clinical studies within the country
- Pro-actively plans for appropriate clinical operations budget consumption and guides line managers and CTLs in managing variances and in developing corrective fiscal action plans.
- Conduct Clinical Project Review and participates in Project Management Review according to regional guidelines and interfaces with appropriate functional leadership to achieve positive outcomes.
- Lead corporate or departmental quality or process improvement initiatives
- Act as a client liaison.
General Manager
Kendle International
2009.10 - 2011.09
- Strategy and Results Orientation
- Accountable for developing and managing top and bottom line revenue growth and expense budgets for Bulgaria
- Work in partnership with function, service, and region leaders in the organization to develop and create an appropriate infrastructure and coordinate cross-functional solutions to support the growth and development of Kendle services within Bulgaria
- Leverages experiences, knowledge and best in class practices to generate new ideas for Bulgaria
- In conjunction with the Functional Management team, ensure that project milestones at the country level are achieved
- Customer Relations
- Functions as the primary contact in Bulgaria for the creation, development and nurturing of key strategic client relationships, ensuring that Kendle is leading the competition in market position in Bulgaria
- Understands and anticipates the needs of the customer to consistently deliver quality service in Bulgaria in a timely manner against contractual obligations
- When appropriate, and in conjunction with Functional management, directly contact clients on project issues related to Bulgaria
- Lead project bids for proposals in Bulgaria; also participate, when appropriate, at bid defense meetings and present sponsor proposals in securing new business
- Leadership
- Conducts monthly Country specific project reviews with operational staff from all functions and local/regional Functional Managers, to ensure effective allocation of resources (utilization and billability), efficient work flow, consistent service levels, compliance with SOPs / Work Instructions and meeting country level project timelines
- Regularly review local Work Instructions to ensure that they allow for the most efficient use of local functional resources and that they fully comply with local regulatory requirements
- Supervises and coordinates with the Support Unit's present in the country (IT, Legal, HR, Finance, Sales, Facilities, etc) or when these Support Unit's do not yet have a representative in the country, works with global/regional Support Unit heads so that these services are provided in the country
- In conjunction with Support Unit's and Functional Management, participates in the selection, management, training and appraisal of staff within Bulgaria
Director Global Clinical Development
Kendle International
2006.10 - 2009.09
- Accountable for the success of the Operating Unit's business in the specified country and for assuring that the country staff work cooperatively with other countries and other operating units in the successful execution of multi-national, multi-operating unit projects.
- Responsible for assisting other operating units, as necessary, in the successful execution of their projects within the assigned country.
- Financial / Performance Management - Budgeting and P&L, Project Management and Business Development
- General Management - Leadership / Strategic Direction, Human Resources, Kendle SOPs, Facilities Management, Integration, External Relations, Legal and Worker's Council Special Projects
Country Manager
Kendle International
2004.05 - 2006.09
- Accountable for the success of the Operating Unit's business in the specified country and for assuring that the country staff work cooperatively with other countries and other operating units in the successful execution of multi-national, multi-operating unit projects.
- Financial / Performance Management - Budgeting and P&L, Project Management and Business Development
- General Management - Leadership / Strategic Direction, Human Resources, Kendle SOPs, Facilities Management, Integration, External Relations, Legal and Worker's Council
Quality Assurance Manager Europe
INC Research Ltd.
2001.08 - 2004.05
- Ensuring that all company clinical trials are performed in accordance with GCP, company SOPs and Sponsor's requirements;
- Ensuring all company offices and sites are audited regularly and as per approved audit plan;
- Planning and performing in house and on-site trial audits
- The audits may be internal, on client's request or with external auditing company.
- Preparation of Audit Reports.
- Performing internal system audits on all company offices.
- Participation in joint inspections.
- Conducting audits on EC and Regulatory Authorities.
- Creation and updates of QA SOPs.
- Planning, development and promotion of the company's QA activities
Head of GCP unit
Bulgarian Drug Agency
1999.09 - 2001.08
- Senior GCP Inspector responsible for various types of inspections in Republic of Bulgaria
- Member of Specialized Committee for Approving Clinical Trials at Ministry of Health
- Other Responsibilities for:the adoption & Implementation of ICH Tripartite Guideline for GCPharmonization of Bulgarian legislation, regulatory regulations and requirementscreation and review and update of departmental SOPs
- Organizing Various Conferences and Training courses for Clinical Research & Development and GCP
Clinical Research Associate
Pharm-Olam International
1998.08 - 1999.08
- Monitoring of clinical studies
- Regulatory submissions
- Customs clearances
- Feasibility, site selection, and translations
Education
High School Diploma -
English Language School
Vidin 2001.04 - 1988.04
M.D. - Medicine
Medical University
Sofia, Bulgaria 2001.04 - 1996.04
Skills
GCP Knowledge
Clinical trial management
Site monitoring
Audit preparation
Patient recruitment
Ethics Committee Liaison
Investigator relations
Onboarding and coaching
Team Management
Office procedures
Clinical Leadership
Training and mentoring
Teamwork and Collaboration
Therapeutic experience
- Infectious disease: Hepatitis B, Hepatitis C
- COVID 19 prevention
- Rheumatoid arthritis
- Complicated Intra-abdominal infections
- CNS: Schizophrenia, Bipolar disorder (2 projects), Parkinson's disease, Alzheimer's disease
- ENT: Sudden idiopathic hearing loss
- Gastroenterology: Crohn's disease, Ulcerative colitis
- Respiratory: Asthma, COPD
- Cardiology: Heart failure, Stable angina
- Oncology: CINV, Pain, Colorectal Cancer, NSCLC, Acne rash in oncology patients, Hematology: Warm Autoimmune Hemolytic Anemia, Acute Myeloblastic Leukemia, Chronic Lymphocituc Leukemia
- Ophtalmology: Macular degeneration
- Various PK studies
- Healthy volunteers
Kendle college courses
- Balanced Scorecard
- TrialWatch – PM, CM, RG training
- EU PL Global resourcing database
- EU PL line management tasks
- EU PL systems (Trial systems & e-forms)
- EU Clinical Trial Directive 21/2002 EC part II
- EU CV repository update requirements
Continuing education and professional meetings
- Training course – Good Regulatory Practice – Drug Institute, Warsaw, Poland
- Training course – Practical GCP compliance Auditing Trials and Systems - London, UK - DIA
- Monitoring Training course - Ascot, Berkshire, UK - Pharm-Olam International
- Monitoring Training Course – Los Angeles CA, USA - Unitas Pharm International
- Human Resource Training – Budapest, Hungary, INC Research
- Project Management Training - Budapest, Hungary, INC Research
- Project Managers' training - Managing Conflict & Difficult Situations in Clinical Research – Poland, International Academy of Clinical Research Ltd, UK
- Training course – Project Finance Review
- Training course – Handling conflict
- Training course – Project Management – on-going
License and certification
Medical Doctor
English language teacher
Presentations
- First Meeting of Drug Regulatory Authorities in CEEC – 1997 (Bulgaria) organizer
- Current Status of GCP & CT in CEE – 1998 (Budapest, Hungary, DIA) - speaker
- Healthcare Management in Europe – 1998 (Bulgaria)
- Bioethics in CEE – 1998 (Bulgaria, Council of Europe)
- IV Phase Clinical Trials in Bulgaria – 1999 (Bulgaria) - speaker
- GCP & CT in Bulgaria – 2000 (Bulgaria) – organizer & speaker
- III International Conference: “Clinical Trials in CEE” – 2000 (Budapest, Hungary, DIA) - speaker
- Clinical Trials in CEE – 2003 (Bulgaria, DIA) - speaker
Personal Information
Date of Birth: 04/16/69
Languages
Bulgarian
Native language
English
Proficient
C2
Russian
Intermediate
B1
Serbian
Upper intermediate
B2
Certification
ICH GCP E6 R2 for Sponsors and CROs 03/2024- 04/2026
Interests
Astrology
Esotericism
Timeline
Director Clinical Operations
INC Research (post acquisition of Kendle International)
2011.10 - 2012.09
General Manager
Kendle International
2009.10 - 2011.09
Director Global Clinical Development
Kendle International
2006.10 - 2009.09
Country Manager
Kendle International
2004.05 - 2006.09
Quality Assurance Manager Europe
INC Research Ltd.
2001.08 - 2004.05
High School Diploma -
English Language School
2001.04 - 1988.04
M.D. - Medicine
Medical University
2001.04 - 1996.04
Head of GCP unit
Bulgarian Drug Agency
1999.09 - 2001.08
Clinical Research Associate
Pharm-Olam International
1998.08 - 1999.08
Senior Clinical Operations Manager Balkan Region
Easthorn Clinical Services in CEE
9 2012 - Current
ICH GCP E6 R2 for Sponsors and CROs 03/2024- 04/2026
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