Clinical Data Manager

Elias MARDHY

WORK EXPERIENCE

April ****- August 2017 Medical Research Institute of New

Zealand, Wellington, New Zealand

Supervised by Pr. Richard Beasley

Clinical Data Manager Internship

Redcap programming, Implementing new databases for administrative and clinical study purposes. Monitoring studies and establishing data quality checks (Novel START, KH10study). January 2017 Saint Eloi Hospital, Department of Haematology, Montpellier, France

Supervised by Pr. Guillaume CARTRON

Clinical research associate Internship

Daily Management of clinical trials, Monitoring the trials (CLLstudy) July 2016- August 2016

Saint Eloi Hospital, Department of Anesthesiology Resuscitation, Montpellier, France

Supervised by Pr. Samir JABER

Clinical research associate Internship

Daily management of clinical trials, by setting up thetrial, collecting the data (e-CRF).

FORMATION

2016-2018 Faculty of Pharmacy,

Montpellier, France

Ongoing – Masters in Health

Engineering - Clinical Operations

Management and Data Management,

Specialty in DataManagement.

2013-2016 Faculty of Pharmacy,

Montpellier, France

Bachelor in Biology, Health

Engineering specialty.

About me

I’m an enthusiastic and cheerful

person who’s eager to expand

his skill set and also, discover

new horizons and cultures.

CONTACT COMPETENCES LANGUAGES

Tel : +33 6 29 96 5517

Addresse: 75 Avenue Augustin Fliche

34090, Montpellier, France

Email: ***********@*****.***

GCP

SAS

EDC

Clinical trials

English

French

Spanish

Clinical Data Manager Student

Full time job / internship

CDISC - SDTM

Elias MARDHY

75 Avenue Augustin Fliche,

34090, Montpellier, France

+33 6 29 96 55 17

***********@*****.***

January 9th, 2018

To whom it may concern,

I would like to apply for a full time work position or for an internship as a Clinical Data Manager at your company.

Following my Bachelor’s Degree in Health Engineering at the University of Pharmacy of Montpellier in France, I am currently preparing a Master’s Degree in Clinical Operation Management and Data Management, which will result, in February 2018, in a specialty in Clinical Data Management. As required, I need to undergo an internship or a working experience as a Clinical Data Manager of at least 6 months to finish my diploma. My course of study has so far been related to a large panel of pharmaceutical courses identical to the pharmacy studies, accompanied by three years of GCP courses, clinical trial regulations and, in the past year, a full specialization in Data Management, using Microsoft Access, SAS, SQL, PL/SQL and EDC systems (Oracle), CDISC Standards, CDASH, SDTM, MedDRA. All of these tools were integrated to the understanding of the clinical study process by the many pharmaceutical professionals across the country.

Moreover, my previous internships as a Clinical Research Associate, followed by an internship as a Clinical Data Manager at the Medical Research Institute of New Zealand in Wellington, gave me the opportunity to learn how to set up and conduct a clinical trial and how to put in place REDCap databases and ensure a good data quality.

These experiences, combined with the clinical study given to us by the Pierre Fabre laboratory, gave me the proper knowledge to set up a database system from scratch. This study has taught me to redact the Data Management Plan, the SOPs, the MedDRA coding, to create the database

(CDISC/CDASH), to monitor it, lock it and to export the data for the statistical analysis. I also believe that my fluency in English will contribute to and ease my insertion in the data management environment. Taking an internship abroad can only strengthen my bilingual ability. The combination of my work experience, my linguistic abilities and the courses I follow at the University will, with what your company has to offer, provide the perfect atmosphere to progress as a Clinical Data Manager.

I would like the opportunity to discuss with you any job or internship opportunities you might have.

Best regards,

Elias MARDHY

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