Dr Milorad Stamenovic, BSc ecc, BSc Med, MSc IBM, MSc PH, M2RMI, PhD ecc - Project manager Clinical trials/Scientific researcher (Health economics, Public health)  - PhD. ecc, med. sci

Dr Milorad Stamenovic

BSc ecc, BSc Med, MSc IBM, MSc PH, M2RMI, PhD ecc

Project manager Clinical trials/Scientific researcher (Health economics, Public health)

PhD. ecc, med. sci

Nice, PACA | France

Main Specialties: Orthopaedic Sports Medicine, Public Health

Additional Specialties: PH

ORCID logohttps://orcid.org/0000-0003-3181-3146


Top Author

Dr Milorad Stamenovic, BSc ecc, BSc Med, MSc IBM, MSc PH, M2RMI, PhD ecc - Project manager Clinical trials/Scientific researcher (Health economics, Public health)  - PhD. ecc, med. sci

Dr Milorad Stamenovic

BSc ecc, BSc Med, MSc IBM, MSc PH, M2RMI, PhD ecc

Introduction


THERAPEUTIC EXPERIENCE:
Therapeutic area: Indication:
Neurology
Alzheimer / feasibility for two studies phase III
Sxhizophrenia with alchohol use disorder
Gastroenterology

Cyrosis-phase III trial,
Cirosis-epidemiology trial,
Chron disease – phase II trial – inductional trial
GIST
Anal fisures
Post operative illeus
Oncology Melanoma
GIST
Breast cancer
Ovarian Cancer
Squamos cell carcinoma of the oral cavity
Reumatology Rheumatoid arthritis – feasibility for trial phase 3
Pulmology Pulmonary Embology Thrombosis
Endocrinology Diabetes – two clinical trials phase III
Dermatovenerology Mastocitosys – feasibility for trial phase III
Cardiology Pulmonary Embology Thrombosis – phase III
Hematology ITP – phase III
Pediatric studies


Surgery

Stem cells

MEDICAL DEVICES:




Hyponatremia
Hemophilia

Surgical Hemostasys (various types of surgeries), Phase II

Stem cells in sphincter dysfunction

Chron’s Disease (neurostimulation), Phase II






EMPLOYMENT HISTORY:
Mar 2016-Oct 2018 ERGOMED PLC
PM/CTM/Line Manager/Training coordinator/QA
Duties and responsibilities of PM:

Project-wise:
Upon request, supporting Business Development group in developing the study proposal as per Client’s Request for Proposal and contributing to the Bid Defence meeting
Serving as Point of Contact for Sponsor
Determining resource requirement for the project; securing the resources in partnership with the Resource Manager, Office Director and Functional Head.
Verifying and ensuring that all assigned project team members (Monitors, Site Managers, CTAs, Lead Site Manager, Data Manager etc) are trained (e.g. GCP, SOP, indication, protocol, study specific procedures / requirements, etc.) to perform their assignments
Organizing and facilitating project meetings throughout the project (study organization, initiation / kick off meeting, investigator meeting, regular project team meetings during project execution, and project close-out meeting) – with project team members, other Ergomed functional groups as needed, vendors and Sponsor, as appropriate
Additional Monitors’ Meetings may be arranged per the project plan, or as required. Those meetings should be documented on Training Attendance Log
Participants of Investigator Meeting should be provided with Investigator Meeting Attendance Certificate for their records. Additionally, meeting agenda, list of attendees and training materials should be filed both in TMF and ISF
Contributing to study documents development as applicable (e.g. protocol, ICF, CRF, CRF completion guidelines, CSR etc.)
Developing/review and revise project plans (e.g. project management plan, communication plan, recruitment plan, risk management plan, monitoring plan, safety management plan, data management plan, etc.) including specific Key Performance Indicators (KPIs) to ensure consistent and timely execution of the project with quality and within budget
Developing study ECIS share folder (with support of IT) in order to facilitate sharing of key study documents / guidelines / templates, and reporting / review of study status and KPIs
Safeguarding quality of study conduct and initiating corrective / preventative measures as needed – e.g. update of study guidance documents, re-training, co-monitoring, etc.
Vendor selection/ qualification as required per the contract
Investigator identification and selection per the contract
Contracting investigational sites (e.g. investigator / team, institution as applicable)
Supporting Regulatory Affairs group in the regulatory and EC/IRB submission process
Reviewing and verifying that all required documents are in good order for the first IMP release to the investigational site
Ensuring the set up and maintenance of the clinical trial master files as per Ergomed SOP (or per Sponsor SOPs) and GCP, including TMF QC
Management of clinical project, including deliverables from all functional areas and vendors in accordance with contractual timelines, sponsor specifications, quality, and GCP
Providing operational (field and in-house) support to clinical study execution, as needed
Reviewing of Monitors’ reports. If the master files are set up and maintained by the Sponsor, the PM or Ergomed project lead will ensure all original documentation, including visit reports, are forwarded to the Sponsor, according to SOP. Periodic review of cumulative listings of study non-compliance issues to assess whether there are any trends at any site or at the study level and determine if any additional corrective / preventative actions should be taken and/or issues communicated to the responsible parties and Sponsor
Reporting project status to Sponsor, assigned Project Director, and Ergomed Senior/Executive Management as requested
Responsible for project profitability
Preparing study budget forecast
Negotiating out-of-scope tasks / units with the Sponsor
Regular reporting to finance department / Head of Clinical Operations
Review of project grants / expense reports, and financial trackers (invoicing/expenses) in a timely manner
Managing the preparations for study specific audits, attending in-house project audits, reviewing audit reports, proposing and overseeing completion of Corrective and Preventative Action Plan
Coordinating the process of study files reconciliation at the end of the trial in preparation for the file transfer to the Sponsor and identifying a sub-set of files to be archived at Ergomed
Contributing to review of Clinical Study Report, as requested
Participating in review cycles to ensure all protocol and GCP deviations were provided to the medical writer
Facilitating the provision of documents and data to the medical writer
In addition to project related tasks, the PM considered as senior project staff, will be involved in development of Company processes and standard operational procedures by supporting the following activities:
Training coordinator – for monitors
Training of the junior monitoring staff & and revision of monitoring related procedures / templates
Working with other training program providers to facilitate provision of agreed training modules and ensure that each step of the program is documented through training logs and progress tracked until competency sign off
Coordination and performance of co-monitoring visits with other senior staff
Trainings for clients on SOP and GCP
Line management role
Line Management role (international), cross cultural management (EU, APEC, USA)
Hiring and initial assessment of new employees
Preparation and assessment of Appraisal forms;
Evaluation of monitors performance in accordance with Appraisal forms and metrics on projects
Completion of timesheet and PTC review
CO-Monitoring and assessment/triggered visits with CRAs (global experience in COMVs/assessment visits: e.g. UK, USA, Germany, Austria, Italy, Bulgaria, Romania, Hungary, Serbia, Croatia, Bosnia, India, Sri Lanka) etc.

QA department role:
QA department should focus on quality assurance as a system and auditing
Audits/Inspections, Co-Monitorign visits organizsed per cause or as part of regular quality assessments
Development and providing quality control processes and procedures which are closer to mentoring, coaching and training
Developing, reviewing and revision of Ergomed SOPs within their area of expertise in order to ensure consistency with Good Clinical Practices and other applicable regulatory standards / requirements
Contributing to Ergomed training programs to enhance knowledge of Good Clinical Practices, related guidance documents, Ergomed SOPs and Working procedures
Assuring adequate quality of TMFs for clients
conducting clinical studies requires a pro-active monitoring of industry trends, uptake of new methods and techniques as well as implementation of continuing professional development program for study teams to stay competitive
Quality improvements, especially of the TMFs,
Handle study-specific tasks within the desired (regulatory-accepted) quality definition
Adopt changes in the industry
Co-visits to study sites,
CAPA development,
Training (monitors, CTAs, etc.),
Annual training plan for the PM Group,
Final QC of TMFs,
QC of key study documents, e.g. Protocols, ICFs, CSRs, etc.
SOP development support to workforce,
Following on new regulations, planning and implementing steps for readiness,
A pro-active uptake of new trends,
Contribution to Lessons Learnt meetings,
Analyses of and support in development of Client, Investigator and other Questionnaires.


Mar 2015 – mar2016


ERGOMED PLC
Lead Monitor/Clinical team manager

Verifying and ensuring that project team members (Monitors, Site Managers, CTAs) are trained (e.g. GCP, SOP, indication, protocol, study specific procedures / requirements, etc. ) to perform their assignments
Contributing to study documents development as applicable (e.g. protocol, ICF, CRF, CRF completion guidelines, etc.)
Safeguarding quality of study conduct and initiating corrective / preventative measures as needed – e.g. update of study guidance documents, re-training, co-monitoring, etc.
Vendor selection/ qualification as required per the contract
Contracting investigational sites (e.g. investigator / team, institution as applicable)
Supporting Regulatory Affairs group in the regulatory and EC/IRB submission process
Reviewing and verifying that all required documents are in good order for the first IMP release to the investigational site
Ensuring the set up and maintenance of the clinical trial master files as per Ergomed SOP, or per Sponsor SOPs and GCP, including TMF QC.
Management of clinical project, including deliverables from all functional areas and vendors in accordance with contractual timelines, sponsor specifications, quality, and GCP
Providing operational (field and in house) support to clinical study execution, as needed
Reviewing of Monitors’ reports. If the master files are set up and maintained by the Sponsor, the PM or Ergomed project lead will ensure all original documentation, including visit reports, are forwarded to the Sponsor, according to SOP.
Managing the preparations for study specific audits, attending in-house project audits, reviewing audit reports, proposing and overseeing completion of Corrective and Preventative Action Plan
Coordinating the process of study files reconciliation at the end of the trial in preparation for the file transfer to the Sponsor and identifying a sub-set of files to be archived at Ergomed
Contributing to review of Clinical Study Report, as requested
In addition to project related tasks, both PM and Lead Monitor, considered as senior project staff, will be involved in development of Company processes and standard operational procedures by supporting the following activities:
Development, review and revision of Ergomed SOPs within their area of expertise to ensure compliance with Good Clinical Practices and other applicable regulatory requirements/industry standards

Oct 2013- Nov 2014
















Aug 2012 – Apr 2013
INC Research Sr.CRA
Completes project activities associated with monitoring functions of Phase I-IV clinical research studies while developing mastery and a thorough understanding of the drug development process, Good Clinical Practices (GCP), and relevant regulations.
Provides clinical and technical support for Clinical Research Associates (CRA) I and II and administrative staff.
Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures.
Clinical trial documents preparation and submission to Local Ethics committees and Competent Authority of Republic of Serbia in accordance with ICH and GCP and local regulations


ICON PLC Clinical research
CRA II
Monitor all stages, from evaluation to close out, of the conduct of clinical trials at assigned trial sites, write reports, maintain required documentation in the Site file and provide required documentation for the Trial Master file.
Ensure compliance of trial sites with study protocol, GCP and applicable regulatory requirements.
Control the integrity of the data produced by trial sites through review of case report forms, source documents, medical and pharmacy records
Verify patient eligibility, communicate and document protocol violations.
Review Serious Adverse Event forms

Jan 2009 – Aug 2012 Pierrel Research SPA, Italian CRO, Belgrade, Serbia
CRA, SCRA,PM
PSV, SIV, PMV, COV in Phase II, III, IV clinical trial, managing and monitoring
Monitoring Phase II,III,IV clinical trials

Translation and submission documentation to EC and CA
Import license obtaining
Co monitoring activities
March 2009 – Dec 2009 IFE FGmbH, German CRO, Belgrade, Serbia
CRA II
PSV, SIV, PMV, COV in Phase II, III, IV clinical trial, managing and monitoring
Monitoring Phase II,III,IV clinical trials
Translation and submission documentation to EC and CA
Oct 2008 – Feb 2009 IFE GmbH, German CRO, Belgrade, Serbia
CRA
PSV, SIV, PMV, COV in Phase II, III, IV clinical trial, managing and monitoring
Trainings and courses:
Best strategies in clinical monitoring
Trial master file training
Electronic trial master file
Computing Environment
Essential documents training
ICH and GCP guidelines training
Clinical trials management system
Contracting Institutions and PIs

EDUCATION:
Oct 2012-present PhDc- Public health and Epidemiology;
PhD dissertation title: Pharmacoepidemiology in clinical trials and new approaches based on statistical analysis, Medical Faculty, Belgrade University, 180 ECTS

Oct 2014-Oct 2017 PhD – Faculty for business studies, John Naisbitt University, PhD dissertation title : Use of strategic management in clinical trials
Oct 2011-Oct 2012 Health faculty – Physiotherapy – BSc in Physiotherapy (180 ECTS)
Comparative of clinical trials of rheumatoid arthritis trough therapy with pharmacology agents in combination with kinesis therapy
Oct 2011- Oct 2013 Master of Science in International Business and management, Internationalprogram of Middlesex University, London, England, Approved Master dissertation theme “International Project Management in clinical trials”, 90 ECTS,
Jan 2011 - Sept 2012 M.Prof. in sanitary ecology engineering - Health Sanitary School of Professional studies, Specialist dissertation theme: “System of decision making processes in field of clinical trials ” , 60 ECTS
Jan 2005- Sept 2010 Faculty for International Economics, Belgrade, Serbia, 240 ECTS

LANGUAGES:

Serbian-Mother tongue, Croatian -very good knowledge, spoken and written, English Advanced knowledge, spoken and written, Russian, German, French-Basics
member of Translators Society of republic of Serbia for English language

COMPUTER SKILLS:
Microsoft Office package, eCRF, CTMS/eTMF, Share points, e-training environment (e.g. I Learn), CTMS’s: IMPACT, ORACLE, FIRECRAST, right track II, Elara; eCRFs: OCRDC, Forward, eDOC,), OpVerdi etc. IWRS, Rave, RECIST, SPSS etc.

LICENSE AND CERTIFICATION:


Certified GCP trainer (internal company certification)
Multiple GCP certifications
Certificate in Good Clinical Practice - GCP - Timisoara, Romania

Certificate in Good Clinical Practice - GCP - Pierrel Research Italy
Certificate in Good Clinical Practice - GCP - Pierrel Research Romania,
Certificate in Good Clinical Practice - GCP - Pierrel Research Europe
Certificate in Good Clinical Practice - GCP - Icon PLC
Certificate in Pharmacovigilance, training, Pierrel Research Certificate of seminar atendance in Pharmacovigilance, CRA Academy

Multiple trainings perfomred throught carrier

Publications/Articles
Year Title
Under review – due date end of 2018 Benefits of outsourcing strategy in new drug development – Management journal, Faculty of organizational sciences

Comparation of benefits of electronic ICFs with current practice – Acta Medica medinae
Actual aspects of marketing in clinical trials – Acta medica medinae medical scientific journal
2017 Editor in chief – International scientific conference (multidisciplinary) TQM, Eurobrand, june 2017

2016 Economic theory and market liberalisation (in terms of drug markets) –Law life International Scientific Journal (supported by UNESCO), 2016; Co-authors: Prof dr Mihajlo Rabrenovic
2016
Importance of strategic management for clinical trials, Law life International Scientific Journal (supported by UNESCO), 2016; Co-authors: Prof dr Mihajlo Rabrenovic, Prof dr Sanja Stosic
2014 Application of Quantitative Methods on problem solving, Internaitonal scientific conference TQM
2012 SUGGESTION OF A MODEL OF A CENTRALIZED SYSTEM FOR PROVIDING SERVICES IN THE FIELD OF CLINICAL TRIALS ON DRUG, International scientific Symposium Symorg 2012, Co-author Prof. Dr Suzana Pavlovic
2013 Lecture by call
MODEL OF A CENTRALIZED SYSTEM FOR PROVIDING SERVICES IN THE FIELD OF CLINICAL TRIALS ON DRUG, International Scientific conference Eurobrand
SUGGESTED METHOD FOR MODEL OF IMPLEMENTATION OF GLOBAL TECHNOLOGY AND OPERATIONS STRATEGY , Romanian International Scientific Journal, Metalurgia

Stamenovi?, M., Pavlovi?. "Suggestion of a model of a centralized system for providing services in the field of clinical trials on drugs". XIII International Symposium Symorg. Faculty of Organizational Sciences, University of Belgrade. ISBN 978-86-7680-855-5. 2012. M31

Stamenovic M, Gulan. B, Dragash. scientific monograph. Serbia Today - Contemporary Aspects of Neoliberalism, Economics, Demography, Health, Security and Transition. Prometheus. 2017 (M41)

Rabrenovi?, M., Stoši?, S. Stamenovi?.M. The importance of strategic management for clinical trials. Belgrade: Legal Life. ISSN 0350-0500. Number 9, 2016. M51

Stamenovic. M, Dobraca. A. Benefits of Outsourcing Strategy and IT Technology in Clinical Trials "Manuscript Number: AIM-2017-08-094. Acta Informatica Medica. Accepted paper for publishing August 2017 (M23)

Book Health Economics and Management M42, Publisher Institute for Economics and Agriculture

Gulan B. and Stamenovi?.M. Promises and Expectations (Economy of Serbia and the European Union; Trading on the international foreign exchange market - FOREX). Novo Miloševo: BKC, 2016 M13

Gulan. B,Stamenovic, M. Land potential. 12th International Multidisciplinary Scientific Conference EUROBRAND. ISBN 978-86-88065-34-4, May 2016. M31

Rabrenovi?, M., Stamenovi?, M. Liberalization in economic theory. Beograd: Pravni život, 2017. M51

Radojlovi?, J. and Stamenovi?.M. "Readiness of teacher of elementary education of primary schools for inclusion in regular classes in the territory of the municipality of Belgrade (Republic of Serbia)". International multidisciplinary conference EUROBRAND, 2013. M31

Stamenovic, M., Cvetkovski, T. Primorac.D. "Challenges in forecasting exchange rates by Multinational corporations in global finance era". ESD International Scientific Conference. ISSN 1849-689X. Belgrade, May 2016 M31

Stamenovic, M., Stamenovic.K. "Application of quantitative methods for problem solving". International multidisciplinary Scientific conference EUROBRAND. ISBN 978-86-88065-31-3. Dec. 2014. M31

Stamenovic, M., Stamenovic.K. "Forecasting new technology in the case of Forex and Equity markets". International multidisciplinary Scientific conference EUROBRAND. ISBN 978-86-88065-31-3. Dec. 2014. M31

Stamenovic, M., Stamenovic.K. "Recommended model of implementation of global technology and operations strategy". Metalurgia International. ISSN 1582-2214. No 2-3, 2014. M24
Tornjanski, V. and M. Stamenovic, V. Pajic, S. Marinkovic. "Evaluation of Eurobank EFG Bank Development Priorities Using Normative Forecasting". Metalurgia International. ISSN 1582-2214, Vol. 4, 2013. (M23)

Tornjanski, V. and M. Stamenovic. Analysis of capital structure patterns of multinational corporations. International multidisciplinary Scientific conference EUROBRAND. ISBN 978-86-88065-31-3. Dec 2014 (M31)

Arrangement of proceedings from the international conference, May 2017 Interdisciplinary Eurobrand Conference (M36)


Memberships od Professional Soceties, Associations

KLINIS - Association for the advancement of clinical trials – member
YUPMA - Serbian Project management Association - member
SENET - South East Europe Project Management Network - member
IPMA - International Project Management association
Association of scientific and technical translators of Serbia - translator for English-Serbian and vice versa
Society of Physiotherapist of Republic of Serbia – member
UK alumni students , Siti klub- member



Primary Affiliation: Project manager Clinical trials/Scientific researcher (Health economics, Public health) - Nice, PACA , France

Specialties:

Additional Specialties:

Research Interests:


View Dr Milorad Stamenovic’s Resume / CV

Education

Apr 2020
SKEMA business school
M2
Sep 2018
Faculty for business studies, Belgrade
PhD
Sep 2018
Faculty for business studies, Belgrade
PhD
Apr 2017
Medical school
Bsc
Oct 2014
MIDDLESEX University London
MSc
Oct 2012
Medical school
MSc
Apr 2010
Faculty of economics, Belgrade
BSc
Apr 2010
Faculty of economics, Belgrade
BSc

Publications

3Publications

2Reads

14Profile Views

1PubMed Central Citations

Contemporary Aspects of Marketing in Clinical Trials Including Segments of IT and Technology Transfer.

Acta Inform Med 2018 ;26(1):67-70

PhD student, Faculty of Medicine, University of Tuzla, Tuzla, Bosnia and Herzegovina.

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Source
http://dx.doi.org/10.5455/aim.2018.26.67-70DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5869228PMC
January 2018
1 Read

Benefits of Outsourcing Strategy and IT Technology in Clinical Trials.

Acta Inform Med 2017 Sep;25(3):203-207

PhD student, Faculty of Medicine, University of Tuzla, Tuzla, Bosnia and Herzegovina.

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Source
http://dx.doi.org/10.5455/aim.2017.25.203-207DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5639890PMC
September 2017
1 Read
1 Citation