C Markovic Email & Phone Number

Gather and generate data-driven insights to support strategic feasibility of clinical studies and programs.Contribute to the holistic planning of programs and trials by inspiring a shared understanding of the impact of program and trial design on Timeline- Risks & Opportunities through clinical performance benchmarks, modelling and lessons learned.Provide transparency of the scope, opportunity and limitation of data and models, and supports Evidence Teams with program and trial planning, including ambitious, yet realistic, baselines end-to-end along the life cycle, as well as trial country allocation.Provide support with:Internal and external benchmarks from the best available databasesData insights that catalyze Clinical Development Scenarios, planning of holistic timelines and budgetsCompetitive analysis and industry landscapeBaselines for measurements of speed, early warnings and predictive analysis

Home Based

Home Based

- Coordinating, managing and facilitating mock inspections (EMA, FDA and PMDA)- Participating to inspections, investigator sites and vendors audits, performing quality checksof TMF and diverse documents including clinical study reports- Identifying inspection risks and developing story boards- Reviewing audit reports, performing Root Cause Analyses, developing and ensuringimplementation of CAPAs- Actively contributing to various cross functional quality and process improvement initiatives- Mentoring and training trial team members and acting as GCP expert.

Home Based

-Successful management of Phase I, II and III onco –hematology full scope projects with up to 500 patients, 16 countries, and 90 sites involved, with vendors, financial, and resources management.-Lead and motivate cross functional study teams and sub-teams to deliver projects within the agreed timelines and budget, and in compliance with the required quality.-Effectively oversee and manage CROs.-Report project status internally and externally as appropriate.-Actively participate at CRAs, Investigators and BID defence meetings -Contribute to the preparation and review of all study documents, specific execution plans; WP and vendors specifications -Actively contribute to the regulatory submission (EMA and FDA) of Sponsor and Investigator Initiated Trials (IIT) supporting Marketing Authorization Application.-Ensure the compilation and maintenance of study documentation (e.g., TMF) including CSR appendices, 120day safety updates.-Ensure clinical trials and related documentation inspection readiness, overseeing adherence and compliance to study documents/Plans, WP and SOPs, GCP guidelines and regulatory requirements-Collaborate in the preparation of up to 50 Investigators Site Audits and Vendors Audits.-Ensure adequate and timely CAPA follow up and collection of supporting documentation of these audits.-Assist in the preparation of regulatory inspections and participate to a GCP MHRA inspection.-Provide advice and support for process improvement, study documentation maintenance and inspection preparedness to collaborative groups implementing IITs.-Participate in process improvement initiatives, including Trial Master File Quality Review processes.-Act as subject matter expert for GCP.-Development, implementation and maintenance of Standard Operating Procedures, forms and templates.-Perform quality review of all study documents including clinical study reports with TLG quality review.

Home Based

-Organization, setting and monitoring of onco-haematology clinical trials.-Contribute in the development of budgets ensuring project objectives and maximizing profitability.-Lead and motivate CRAs to deliver projects on time, within budget and with high quality.-Develop, review and edit clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists.Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required.-Report project status internally and externally as appropriate.-Prepare and conduct audit support visits, and ensure adequate and timely CAPA follow up.-Support the Clinical Operation Director for the implementation of operational processes.-Development, implementation and maintenance of Standard Operating Procedures, forms and templates.-Participate in various quality initiatives for process improvement.

Home Based

-Represent the company to prospective clients, and identify appropriate clients and opportunities.-Collaborate in the development of Request for Information and Request for Proposal.-Major contract award for CPR and instigate creation of SKM France subsidiary-Develop and update Data Base of prospective clients.-Identify appropriate trade shows, conferences, and conventions and actively participate.

Région De Genève, Suisse

-Development of SOPs for CRAs/monitors and investigators involved in clinical trials sponsored by the WHO Special Programme for Research and Training in Tropical --Diseases (TDR) and HVI.-Training of monitors, investigators and members of ethical review committees in developing countries on GCP.-Responsible for the development of the UNAIDS Guidance Document "Ethical considerations in HIV preventive vaccine research".-Contribute in the development of the WHO/TDR "Operational Guidelines for Ethics Committees that Review Biomedical Research".-Perform an Ethical review of phase III efficacy HIV vaccine clinical trial.-Collaborate in the development, revision and update of "National AIDS Vaccine Plans" for developing countries submitted to HVI (The HIV Vaccine Initiative of the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS)).-Review of research proposals and HIV preventive vaccine clinical trial protocols.-Organization and facilitation of workshops and scientific meetings.-Responsible for administrative issue of HVI, including budget and development and update of the HVI website.

Région De Paris, France

-Organization, setting and monitoring of clinical trials, phase I, to III, (France, Israel, Italy, Thailand, Taiwan, Vietnam) -Develop, review and edit clinical trial related documentation including but not limited to; Case -Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists. -Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required.-Prepare and conduct audit support visits, and ensure adequate and timely CAPA follow up.-Support the Clinical Operation Director for the implementation of operational processes.-Development, implementation and maintenance of Standard Operating Procedures, forms and templates.-Participate in various quality initiatives for process improvement.

Région De Paris, France

University Diploma, Auditor In The Pharmaceutical Industry, Quality Assurance - Audit

Gcp Auditor Certificate, Good Clinical Practice Auditing: Principles And Practice

University Diploma In Methodology For Therapeutic Evaluation

Certificate Of Medical Representative

University Diploma Of Technology In Statistics And Data Management, Statistics And Data Management