Antwerp, Flemish Region, Belgium
Dedicated research professional with more than 15 years of experience in the healthcare, academia and biotechnology/pharma industries as a physician, senior clinical team lead, director of clinical development, clinical project manager, clinical research manager and clinical data manager. Awarded a Medical Degree from the accredited School of Medicine at the Universidad Autónoma de Guadalajara in Mexico and credited to practice medicine in Mexico. Deep knowledge in clinical research trials protocols execution, financial management and pharmacovigilance regulations, as well as ICH/GCP, FDA, EMA and institutional regulations nationally and internationally. “Hands-on” experience in clinical research within different settings including project management, regulatory submission, budget negotiations, patient recruitment and care, protocols operations, laboratory procedures and electronic data capture systems for more than 9 years in oncology, hematological rare diseases and dermatological aesthetics(phases I – IV) and 2 years in dermatological aesthetics. Recognized for exceptional scientific knowledge, management of complex trials and for skillful patient relationship management. Routinely acknowledged for exceptional communication skills, as well as bilingual capabilities with Spanish and English.
Developing first in class mRNA immunotherapies for the treatment of cancer and infectious diseases.
Senior staff member responsible for the management of multiple clinical projects with the goal a successful implementation of a new indications from existing aesthetic brands approved in USA and bringing new products from our European portfolio for FDA approval. Current projects include new glabellar injection, chin volume augmentation and a new product for the mid face volume augmentation. • Manage global cross-functional teams of professionals responsible for product development from early stage until launch. Currently in the approval process of pivotal product and indication to expand the existing portfolio. • Responsible for vendors and CRO procurement as well as contract review, reconciliation and negotiations. • Create and review multiple clinical operations manuals, safety manuals and monitoring manuals. • Lead in the selection process of sites and medical experts participating in each project. • Train multiple members participating in the protocols such as principal investigators, coordinators, CRA’s and other senior staff members. • Oversees daily activities of project such as monitoring reports, IP distribution, daily data review, TMF audit, etc in conjunction with multiple staff members including other CPM, CRA, regulatory experts and medical writers across US and Europe. • Successfully submitted initial IND and PSUR annual reviews. Responsible for drafting the appropriate response to FDA inquiries. • Conduct relationship building with principal investigators and medical partners as well as continue communication with vendors and potential new parties.
Project leader and medical science liaison of the solid tumor program responsible for multiple clinical trials implementation globally with sites across United States, Europe and Asia. Manage trials phases I trough III with indications of gastric cancer, glioblastoma and sarcoma. • Responsible for the opening of new sites nationally and internationally as well as conducting SIV while educating other team members and institutional partners. • Acted as primary liaison with investigators and vendors. • Lead and directed cross-functional team leaders and third parties/vendors with supervision and support. • Managed and negotiated project budget with sites, CRO’s and vendors. • Participated and attendance in bid defense process. • Acted as lead speaker in multiple investigator meetings across US, Europe and Asia. • Provided feedback on project team members’ performance to respective line-managers. • Maintained detailed understanding of each functional service area and lead multifaceted functional teams effectively with little supervision or support. • Developed in depth analysis and projections of project timelines and financials for senior and customer management.
Managed and reviewed research study procedures to ensure receipt, completeness, and accuracy of research data required by our pharmaceutical industry partners as well as non-profit national organizations partners in the fields of neuro oncology, benign hematology and skin malignancies. Collaborated with physician in determining eligibility of patients for clinical trials. Provided education to staff and patients. Ensured site research quality by practicing in compliance with the university of Texas southwestern medical center standard operating procedures, principles of Good Clinical Practice and applicable federal, state, and institutional regulations. • Coordinated all regulatory aspects, such as preparing safety reports, adverse events, FDA compliance, laboratory standards as well as maintaining databases related to each specific trial. • Coordinated aggregation and maintenance of local and national research data required to ascertain and identify research study outcomes. • Developed and prepared statistical research reports, charts, and graphs as required during research studies. • Served as primary liaison and prepared annual reports for federal, state, and/or local agencies with duties including informing Institutional Review Board of amendments to research studies, preparing protocols and detailed summaries in lay terms of any new research study. • Head of special task force created with the principal focus of underprivileged subject recruitment with the final goal to obtain an NCI designation.
Gathered and coordinated statistical information and treatment data from clinical trials in the specialties of Malignant Hem/BMT, GI, Breast Cancer, Head and neck, Melanoma and Lung malignancies. Worked with multiple cross functional teams to provide administrative services for compilation of data resulting from multiple clinical trials from multiple sponsor partners and investigator initiated protocols. • Reviewed inclusion/exclusion criteria, read medical charts and entered data on new subjects. • Submitted confidential record and research material to study group’s reviewers at other institutions when applicable. • Performed User Acceptance Test, provided summary checklist and Query Management. • Coordinated collection and data management of national research studies from multiple projects by interacting with internal and external research data managers, patients, and physicians for coordination of tissue samples, lab data and protocols, and other statistical information concerning research study subjects. • Obtained statistical information concerning subject’s tests performed or received treatment elsewhere. • Managed preparation of annual or terminal summary for each research study plan and actual subject care.