CV – MARIA DEL PIL AR GIMENEZ PEREZ Covance Clinical Development Services, Barcelona, Spain – Oct 2004 – presentSenior CRA – Oct 2004– present

Since February 2014 until Aug 2014 acting as Coordinator of Data Management tasks (missing pages, queries

and Patient Report Outcomes) for European and APAC sites of one on the studies which I’m involved.

Set-up of studies, pre-studies and site initiation visits of international clinical trials.

Feasibility and Financial Management of the project

International Investigator’s meeting and International Monitor’s meeting attends

Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical

sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other

duties, as assigned

Responsible for all aspects of site management as prescribed in the project plans

General On-Site Monitoring Responsibilities:

o      Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study

o      Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements

o      Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data

o      Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy

Prepare accurate and timely trip reports

Manage small projects under direction of a Project Manager/Director as assigned

Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned

Review progress of projects and initiate appropriate actions to achieve target objectives

Organize and make presentations at Investigator Meetings

Report, write narratives and follow-up on serious adverse experiences

Participate in the development of protocols and Case Report Forms as assigned

Participate in writing clinical trial reports as assigned

Interact with internal work groups to evaluate needs, resources and timelines

Act as contact for clinical trial supplies and other suppliers (vendors) as assigned

Responsible for all aspects of registry management as prescribed in the project plans

Undertake feasibility work when requested

Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities,

translation of study-related documentation, organization of meetings and other tasks as instructed by

supervisor as assigned

Negotiate study budgets with potential investigators and assist the Covance legal department with statements

of agreements as assigned

Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and

follow up of SAEs

Independently perform CRF review; query generation and resolution against established data review

guidelines on Covance or client data management systems as assigned by management

Assist with training, mentoring and development of new employees, e.g. co-monitoring

Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and

may act as a local client contact as assigned

Perform other duties as assigned by management

Recerca Clinica, CRO, Barcelona, Spain – Sep 2002 – Sep 2004Senior CRA – Sep 2002- Sep 2004

I have been involved in several therapeutics areas like Respiratory, Dermatology, Ophthalmology, Oncology,

Hematology, Neurology, Infectious and Gynecology.

Coordination of other CRA’s and supervising the following documents: Monitoring Reports, SAE reports and

all procedures related to study drug.

Organization of Investigator’s meeting as coordinator and speaker.

Hospital Vall d’Hebron, Oncology Service, Barcelona, Spain – Nov. 1999 – Aug.2002Study Coordinator – Nov 1999- Aug. 2002

Monitoring on Phase I, II and III studies following the GCP and the SOP´S of each company.

Data Management, patient’s randomization, queries resolution, attendance at Investigator’s meeting, SAE’S

and all the shipping and sampling procedures related to study drug.

Coordination of a National study about breast cancer.

Therapeutic ExperienceExperience on different therapeutic areas

Dermatology (multiform Erythema) Digestive (Crohn ´s disease) Phase III Hematology (Hodgkin’s and Non Hodgkin’s Lymphoma) Infectious (AIDS) Oncology Therapeutic Area (Breast, Lung NSCLC and SCLC, Glioblastoma, Hepatocelular carcinoma,

Colorectal Cancer, Head and Neck, Ovarian cancer, Genetic Therapy and solid tumors) Phases I, II and III.

Ophthalmology (implant in non infectious uveitis) Phase II Respiratory (Asthma) Phase III Special Senses Indications: Rheumatoid Arthritis Neurology (Vascular Dementia)

Language Capabilities Mother tongue: Language: Spanish

Fluent Language (s): English

Education Degree in Optics and Optometry

Polytechnic University of Catalonia Barcelona Spain

Master Science in Clinical Trials Monitoring

University of Barcelona Barcelona Spain

Postgraduate in Medicine for the Pharmaceutical Company

Hospital de San Pablo Barcelona Spain