SONIA MARTÍN FERNÁNDEZ

Sonia Martín BSc, MSc Telephone Number: 635 580 173 E-mail: sonmafer@gmail.com I am a very meticulous person, active, responsible, flexible and a good team worker. I like working with people, friendly contact and I am sure I am able to perform any job in Pharmaceutical sector as I consider it a goal and a reorientation of my professional career. The trust in my experience in Clinical Trials Start Up and monitoring training enable me to manage any clinical trial from the very beginning to the end successfully.

WORK EXPERIENCE

MAY 2015 TO NOWADAYS NOVONORDISK (ALPHA BIO RESEARCH) CTA Key outputs: Contribute to meeting targets set for the department by way of administrative management of the assigned clinical trials . Supplies/equipment tracking system Study payment spreadsheets/invoices and budgets Accurate SOP compliant filing systems Arranging internal and off-site meetings taking minutes and acting upon matters arising Key measures: Efficiency and effectiveness of administrative systems and processes Inspection/audit results for SOP compliance Delegate feedback from events and meetings SOP compliance Quality of relationships with internals and externals Responsibilities: -Provide administrative support in the compilation and submission of Clinical Trial documents to investigators, Ethics Committees, Hospital Management and the Spanish Medicines Agency. -Prepare and maintain Clinical Trial files. -Take delivery of, control, send and follow-up Clinical Trial material. -Perform general departmental administrative tasks: scheduling meetings and taking minutes, Co-ordinating events (conferences). -Processing Clinical Trial payments/bills and suppliers. -Co-ordinating functional resources including consumables and administrative equipment and supplies. -Handling external and internal enquiries made via telephone, e-mails or face-to-face. -Internally distributing safety notices related to clinical trials in connection with the local drug safety group of the Corporate Relations department. -Back-up of Regulatory -Local Administration of Archives (OMNIRIM)

-Individual Specific taks: (i.e: Local Record Manager, novoDOCS superuser,…):

OCTOBER, 2014 – MAY 2015 JANSSEN CILAG (INVENTIV HEALTH) Start Up Unit

-Submission of Clinical Trials and Amendments to Ethics Committees and Principal Investigators.( preparation of submission, assisting with fulfillment and management of signed documents required by Sponsor an PIs.) -Telematic submission, PANAKEIA (telematic submission in Andalucia) and incidences resolution concerning EC`s and Website application. -Elaboration of Annexes 1A and 1C for submission to ECs -Payments made using Ariba application and Ethics Committees' fees -Storage archive and Electronical Trial Master file (eTMF)

JANUARY 2008-FEBRUARY 2014 ROCHE FARMA CLIENT ( INVENTIV HEALTH): ETHICS COMMITTEES UNIT -Centralize clinical trial contract templates ensuring the signature process and the achievement of Site Management Approvals. Centralize clinical trial contracts in order to obtain the accomplishment of contracts signed by all parts involved in the signature process.

-Post-authorization and non- post –  authorization studies management. Contacts with Clinical Research

Organizations for questions related to clinical trial contracts management and processing. -Unite all kind of information related to Ethics Committees submissions in order to inform the study local team members about the progress with their current on- going clinical trials. etc

-Back up for Ethics Committee Unit induction training for new hires

-Contact with Ethics Committees for questions related to clinical trials submissions, tracking of necessary Approvals, following up the information related each Ethics Committee. Control and updated tracking of each clinical trial progress (Approvals,/ Site Management Approvals/ Contracts/ EC Excel worksheet registration. -Request of compulsory clinical trial documentation for submission and later tracking. Ethics Committees

Requirements and current contract Templates. -Inform the study local team members about the progress related to their clinical trials - Medical and other Departments support for questions related to clinical trials submissions, information gathering, reports about clinical trials and clinical sites, surveys..etc

-Ethics Committee Unit Databases: development, demos, and processes implementation.

- Sharepoint Tool Collaboration: rename Ethics Committees requirements and Contract templates. Ethics Committees and contracts Sharepoint/Touchpoint maintenance, development and update. -Close cooperation with Legal Department, submission of Reference Committee Reports, and new sites start up (Site Management Approvals)

-Keep “Farmaindustria”  (Spanish Association for the Pharmaceutical Industry”  -Metrics Database up to date.

Introduction of assigned clinical trials in Metrics BD. -Ethics Committee and contract Unit Sharepoint creation. -Identification and Enhancement of internal work software tools. -Telematic and PANAKEIA (Andalucia Community) submission, nowadays compulsory in Clinical Trials, Amendments, requested Clarifications and notifications. Incidents resolutions related to Ethics Committees Internet Web Portal.

MAY 2007-DECEMBER 2007 ROCHE FARMA CLIENT ( INVENTIV HEALTH) Drug Safety Unit. Archive, administrative tasks and mailing arrangement. Package delivery company management and Travelling booking. AEMPS (Spanish Agency for Medicines and Health Products) Auditing preparation. NOVEMBER 2004-MAY-2005 OXFORD OUTCOMES LTD & 3D-HR Clinical Psychology collaborator in the Company Psychology team assuming administrative tasks and patient’s clinical interviews related to Health studies.

1995-2004: Different jobs.

EDUCATION

2002-BACHELOR DEGREE IN PSYCHOLOLOGY Clinical Education Specialist. Universidad Autónoma of

Madrid. 2002. 2014-ICH GCP COURSE 2014-MASTER DEGREE IN CLINICAL TRIAL MONITORING AND MEDICAL AFFAIRS.CESIF.1650 hours

ADDITIONAL SKILLS

COMPUTER SKILLS Computer programs usage in Windows, Officce, Internet and email Environment. (User level in last two ones listed above) LANGUAGES Written and spoken English B2 level

OTHER INFORMATION OF INTEREST

I have worked as teacher trainer giving courses to elder people from beginner to internet advanced I have also worked as an educator of children, psychologist in different fields and as a volunteer of the

Red Cross.

On the other hand, I have been involved in the promotion of Infanta Sofia Hospital`s creation. I worked in Corte Ingles as a telephone operator and in Customer Service Department.

I played tennis for 12 years, taking part in tennis tournaments and being second-place in two of them.

Additional training: JUNE 2013-COURSE NUTRITION HEALTH-6 weeks online with Vanderbilt University MAY 2007-2013-ONLINE TRAINING: Information security, conflicts of interest, Ethics and Integrity

program…. Inventiv Health. One day each course CLASSROOM TRAINING Presentations to Public Audiences, Occupational Hazard Prevention, Clinical

Trials Audits, Professional Leadership – Inventiv Health –One day each course

SEPTEMBER-DECEMBER 06-JOB TRAINER MASERCISA. 330 h. Madrid OCTOBER 04-MAY 05 - C.A.P. CURSO DE ADAPTACIÓN PEDAGÓGICA. POSTGRADUATE

TEACHER CERTIFICATION PROGRAM Instituto de Ciencias de la Educación. ..U.C.M. Education and Sciences Institute.U.C.M

DECEMBER 02-MARCH 03-INFANT AND YOUTH ACTIVIST IMEFE. 300 h. Madrid 1997-2002- Different courses related to training and Psycholology.

MAY 1997-THE SILVA MIND CONTROL METHOD 40 h. Madrid.