1. CV – MARIA DEL PILAR GIMENEZ PEREZ
Covance Clinical Development Services, Barcelona, Spain – Oct 2004 – present
Senior 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 siteinitiation 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 sitemonitoring 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 theproject plans
 General On-Site Monitoring Responsibilities:
o Ensure thestudy staff who will conduct the protocolhave received the proper materials and
instructions to safely enter patients into the study
o Ensure theprotection of study patients by verifyingthat informed consent procedures and protocol
requirements are adhered to according to the applicable regulatory requirements
o Ensure theintegrity of the data submitted on Case Report Forms (CRFs) or other data collection tools
by careful source document review. Monitor datafor missing or implausible data
o Ensure theresources of theSponsor 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 protocolor project and may assist in establishing monitoring plans as assigned
 Review progress of projects and initiate appropriateactions to achieve target objectives
 Organize and make presentations at Investigator Meetings
 Report, writenarratives and follow-up on serious adverse experiences
 Participatein thedevelopment of protocols and Case Report Forms as assigned
 Participatein 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 theproject plans
 Undertake feasibility work when requested
 Recruitment of potentialinvestigators, 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 potentialinvestigators 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

2.  Independently performCRF 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 2004
Senior 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: MonitoringReports, 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.2002
Study 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 shippingand sampling procedures related to study drug.
 Coordination of a National study about breast cancer.
Therapeutic Experience
Experience 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) PhaseIII
 Special Senses Indications: Rheumatoid Arthritis
 Neurology (Vascular Dementia)
LanguageCapabilities
 Mother tongue: Language: Spanish
 Fluent Language (s): English
Education
 Degree in Optics and Optometry

3. Polytechnic University of Catalonia
Barcelona
Spain
 Master Science in Clinical Trials Monitoring
University of Barcelona
Barcelona
Spain
 Postgraduate in Medicine for thePharmaceutical Company
Hospitalde San Pablo
Barcelona
Spain