Clinical Research Management

Mrs Sefika OZTURK, Ph. D

**** *** **********, ******, **, H4G1A1 tel. 514-***-****, email: **************@*****.*** PROFILE

PhD in neurobiology with over 7 years in Life Science projects management and in Clinical Research.

Guidelines: ICH GCP (E6, E2) & FDA 21 CFR 312, 56, 50, 54 & Form 1572, F&D Act, Div.5, FRSQ

Computer: Pack Office (Word, Excel, PowerPoint, Visio), Inform, RAVE, TAO Language: French mother tongue, English (advanced professional level), German

(school level)

Therapeutic Areas: Neurobiology, Endocrinology, Cardiology and Infectious Diseases PROFESSIONAL EXPERIENCE

Clinical Research Coordinator December 2014

Clinique OPUS, Medicine Urbaine, Montreal

Clinical Trial Design, Study Conduct and Monitoring SOPs

Management and Coordination of multiple studies

Preparation/review/approval of regulatory documentations

Subjects Recruitment and Retention, Data Management

AE/SAE Reporting, Query Resolution, Audits, Submissions

Medical devices regulations, IDE, PMN, PMA

Clinical Research Assistant 2014-present

Clinical Research Training Center-Montreal

Project Management in Pre-Clinical Research (Neurology) July/2013–Nov 2014 Montreal Neurological Institute, University of McGill.

Resource planning, developing schedules, reporting progress

Time and cost estimating (70 000$)

Supervise 4 undergraduate/graduate students

Project Management in Pre-Clinical (Neurobiology) Dec 2009 to June 2013 Institute of Neuropathology, Bale, Switzerland.

Managing and leading the project team (3-8 persons)

Managing coordination of the partners and working groups engaged in project work

Time and cost estimating (300 000$)

Developing and maintaining a detailed project plan Project Management in Endocrinology 2008-2009

Department of Nephrology and Hypertension, University Hospital, Bern Switzerland.

Developing and maintaining a detailed project plan

Developing schedules

Reporting progress

Research assistant work 2007-2008

Institute of Molecular Signalling and Neurodegeneration (INSERM), U692, ULP, Strasbourg, France.

EDUCATION

Clinical Research Professional Certificate August 2014 to present Clinical Research Training Center – Montreal

ICH GCP (E6, E2)&FDA 21 CFR 312, 56, 50, 54 & Form 1572

Clinical Trial Design, Study Conduct and Monitoring SOPs

Clinical Sites Selection, Management and Coordination

Subjects Recruitment and Retention, Data Management

AE/SAE Reporting, Query Resolution, Audits, Submissions

Medical devices regulations, IDE, PMN, PMA

Research Scientist 2013-2014

Montreal Neurological Institute, University of McGill PhD in Neurobiology 2009- 2013

Institute of Neuropathology, Bale, Switzerland

PhD internship in Molecular Biology 2008-2009

Department of Nephrology and Hypertension, University Hospital Bern Switzerland

M.Sc. in Pharmacology 2006-2008

Louis Pasteur University, Strasbourg, France

COMPETENCES

- Maintained updated information:

Maintain effective communication tools and documentations

Provide feedback and status updates to internal and external collaborators

Meet the appropriate timelines at the site

-Provided assistance:

Site monitors

Clinical site manager

Physicians and researchers

-Issue resolution:

Answer/resolve to site related stakeholders (site monitors, clinical data manger, sponsors)

Resolution of queries

SKILLS

- Proven ability to handle multiple assignments & meet deadlines

Managed 12 projects at a time

Obtained results earlier than expected

Presented in internal and external meetings

- Analytical approach to problem solving

Set up all methodologies used in laboratory and in clinic

Established new procedures to analyse tissue

Established new procedures to coordinate the flow in clinic

- Proactive and highly motivated

Identified and resolves issue noted during any procedures

Coordinates initial and ongoing training of study staff

Suggested improvements of SOPs in laboratory by changing some conditions

- Dynamic, flexible & adaptable professional, high ability for quick assimilation of information

Switched quickly from practical to written work

Collected data from others and organized in a time manner

- Strong oral & written communication skills in English and French

National and international congress

Peer reviewed publications in relevant journals

- Excellent skills of organization, project management and time, tracking project costs and schedules, conducting meetings and trainings, effective communication and influencing skills

Successfully managed 4 projects in neurosciences and 12 projects in clinical research

Organized meeting with PIs, lab and site members

Trained 5 students and serves as a resource for colleagues

- Exceptional work ethic and ability to work in collaboration in interdisciplinary area, worked in a multicultural environment.

References: Available on request

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