Ana Robledano
Summary
I'm a motivated, customer-focused start-up team manager (STM) for Project Delivery, with over 20 years of experience in clinical research and the pharmaceutical industry. My depth of experience managing the Start-Up of clinical trials consists of all phases I, II, and III trials, including the implementation of study protocols, feasibility, site selection, and site activation, oversight of submissions to regulatory and local country authorities as a Global and Regional STM across North America, Asia Pacific, Latin America, and Europe.
Overview
23
23
years of professional experience
Work History
START-UP TEAM MANAGER
PPD (Thermo fisher scientific (since Dec2021))
Madrid
06.2018 - Current
- Lead, execute and achieve site activation and amendment deliverables within a region or globally, within the assigned projects, by managing the scope of work to timelines, costs and quality.
- Ensure all project deliverables meet contracted and customer’s expectations, providing accurate projections, reports, and updates, as well as ongoing risk assessments.
- Develop and maintain strategic relationships with customers in alignment with assigned projects, ensuring individual project targets are met clients are satisfied, services are provided with the highest quality standards, and policies and procedures are followed.
- Creates and presents business development materials for SIA, under AD/Director supervision. Guides, mentors, and trains Regional STMs, Functional Managers, and country team members on project and team management principles. Offers support to new staff needing mentoring.
- Collaborates with the team to set up proper controls to ensure project resources and expenses stay within budget while being accountable to Global Project Management.
- Serve as the primary startup contact for the Project Lead and clients.
COUNTRY APPROVAL SPECIALIST
PPD
Madrid
04.2010 - 05.2018
- Prepared, reviewed and coordinated the local regulatory submissions (MoH, EC and additional special national local applications when applicable) aligned with the global submission strategy
- Provided project specific local submission strategy, technical expertise and coordination oversight for projects in collaboration with relevant internal departments
- Primary contact for investigators and for local regulatory authorities to ensure submissions were managed in a timely manner
- Acted as a key contact at country level for all submission related activities and ensured the submission process for sites and studies were aligned to the critical path for site activation
- Prepared Regulatory Compliance Review packages, and developed country, and site-specific Patient Information Sheet/Informed Consent form documents
CRA- START-UP
PPD
Madrid
05.2008 - 03.2010
- Performed and coordinated identification of qualified study sites, site evaluation visits by IGH, GCP & FDA guidelines and global SOPs to ensure the selection of appropriately qualified sites
- Worked in conjunction with the Country Approval Specialists and Contract Specialists to prepare investigational sites for initiation
- Represented PPD in the global medical research community and developed collaborative relationships with investigational sites
- Supported local Country Manager/Start-up in the mentorship, training and work direction of local Start-up team members
- Identified and suggested potential process improvements
- Provided feedback on tools, processes and procedures
- Acted as a point of reference for operational and role-specific
CLINICAL RESEARCH ASSOCIATE
PPD
Madrid
10.2005 - 04.2008
- Performed pre-study, initiation, interim monitoring and close-out visits
- Acted as Lead CRA, reviewed and approved monitoring visit reports and secondary CRF review
CLINICAL RESEARCH ASSOCIATE
Astellas Pharma
Madrid
08.2002 - 09.2005
- Performed pre-study, initiation, interim monitoring and close-out visits
RESEARCH ASSISTANT
01.2002 - 06.2005
- Research Assistant in a global phase III study Performed filing and RTMS tracking
- Assisted in the investigator selection
- Participated in the Start-Up activities such us, EC submissions, RCR packages, etc
Education
MSc - Pharmaceutical and Para-pharmaceutical Industry
Center for Advanced Studies of the Pharmaceutical Industry (CESIF)
Madrid, Spain01.2002
B.S. - Pharmacy
Universidad de La Laguna
Tenerife, Spain01.2001
Skills
- Solid understanding of global/regional/national regulatory requirements and procedures, including EU CTR legislation
- Thorough knowledge of ICH and other global regulatory guidelines
THERAPEUTIC AND INDUSTRY SUMMARY
Experienced in conducting Phase I-IV clinical studies in adults and pediatrics across North America, Latin America, Asia Pacific, and Europe. Therapeutic expertise includes:
- Circulatory: Giant Cell Arteritis
- Infections/Parasitic Diseases: Severe Sepsis, Flu
- Oncology: Liver, Breast, Head and Neck, Lung, Lymphoma, Colorectal, Solid Tumors
- Vaccines: COVID studies
- Transplant: Kidney Transplant
- Hematology: Relapsed or Refractory Multiple Myeloma
- Nervous System/Sense Organs: Acute Non-Hemorrhagic Stroke, Transient Ischemic Attack (TIA)
- Respiratory: Asthma
- Neurosciences: Schizophrenia
- Rare Diseases: Duchenne Disease
Languages
Spanish (native)
English (professional competence)
Additionalrelevantexperience
- Audit experience: Process Audit (Internal & Sponsor).
- Systems Experience: Clinical Trial Management System (CTMS), eTMF (Veeva Vault), Activate- Gobalto.
Timeline
START-UP TEAM MANAGER
PPD (Thermo fisher scientific (since Dec2021))
06.2018 - Current
COUNTRY APPROVAL SPECIALIST
PPD
04.2010 - 05.2018
CRA- START-UP
PPD
05.2008 - 03.2010
CLINICAL RESEARCH ASSOCIATE
PPD
10.2005 - 04.2008
CLINICAL RESEARCH ASSOCIATE
Astellas Pharma
08.2002 - 09.2005
RESEARCH ASSISTANT
01.2002 - 06.2005
MSc - Pharmaceutical and Para-pharmaceutical Industry
Center for Advanced Studies of the Pharmaceutical Industry (CESIF)
B.S. - Pharmacy
Universidad de La Laguna
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