Design, develop, and deliver comprehensive teaching content as a Subject Matter Expert, incorporating innovative didactic techniques to facilitate effective learning and knowledge transfer for undergraduate students. Leverage industry expertise to bridge theory and practice, fostering critical thinking and real-world application to prepare students for professional success. Topics:- Business Operations and Processes- Business Operations ResearchPrograms:Business Administration Bachelor's Program

Mentor, overseer, and administrator of a data operations team of international professionals with different seniority levels to ensure proper resource allocation, training, and performance and to contribute with career development and success, thereby securing the achievement of the clinical data management department and corporate operational and financial goals. - Managed a multinational team spanning the U.S., Brazil, Colombia and Mexico, achieving four promotions within a year and improving cross-cultural collaboration, and ensuring proper resource allocation and workload resulting in the reduction of staff rotations within 2 years. - Fostered team development, resulting in enhanced career growth and achievement of two successful EDC go-lives, three database locks, the rescue and set in proper state of five projects, and the obtaining of two project awards in bid-defense meetings collaborating in this way with the achievement of departmental and corporate operational and financial goals.

Directed data operations functional leads and supporting areas to ensure the success of clinical trial programs associated with the implementation of strategies and technological tools to ensure the appropriate capturing and clinical data quality during the development life cycle and release to market of innovative biotechnological products. - Planned and implemented an eTMF data management initiative that streamlined documentation filing processes, reduced rework hours, and ensured regulatory compliance through the department. - Designed and developed the improvement of process-controlled documents and templates to ensure an optimal and complete creation of study-customized data management plans. - Designed semi-automated patient data cleaning trackers for studies with fewer than 100 participants, reducing database lock times by two weeks and increasing data quality indices from 98.5% to 99.5% across seven clinical trials as a pilot program. - Played a key role in three bid defenses, securing four clinical trials valued at $45 million USD. - Main lead and manager in the company spearhead master protocol oncology platform clinical trial program consisting of five ongoing studies with requirements as real-time data cleaning and monthly data deliverables. - Reviewed and enhanced electronic data capture system e-mail alerts, mitigating the risk of confidential data breaches. - Data management functional lead project oversight and primary escalation contact for twelve clinical trials in parallel. - Subject Matter Expert in data governance regulation, project and financial health review participating as an internal consultant for other leads in these topics and in internal initiatives to improve the revenue pick-up within the company for the achievement of the data management department yearly goals during 2023.

Lead data operations functional leads and supporting areas to ensure the success of projects associated with the implementation of strategies and technological tools to ensure the appropriate capturing and clinical data quality during the development life cycle and release to market of innovative biotechnological products. - Successfully rescued seven transitioned oncology studies, reversing financial losses and stabilizing project budgets. - Developed and updated SOPs, documentation templates, and training programs, reducing bottlenecks and enhancing department efficiency. - Support and partnership with direct project reports career development accomplishing the promotion of one Sr. Clinical Data Specialist (CDS) to Lead Clinical Data Manager (LCDM) and from one Clinical Data Specialist to Sr. CDS and collaborating for the reduction of personnel turnover in just one year.

Leading position for the building, development, performance improvement and allocation of a highly efficient Clinical Data Associates team to ensure the proper execution and continuity of the related activities within the data operations department.

Functioned as the clinical data management project lead, overseeing the planning, execution, risk management, and closure of projects to ensure high-quality clinical data capture and compliance throughout the development lifecycle of human therapies. - Implemented agile project management methodologies, delivering six databases (including five rescue projects) on schedule with an average error ratio below 0.15% within two years. - Successfully executed a risk-based strategy, eliminating multiple data base migrations during study conduct, and reducing project cost variances by 8%-10%, and improving efficiency. - Cultivated and managed high-performing multicultural project team achieving: - Zero turnover during study durations, minimizing delays and quality issues - Seven promotions within the team over two years, fostering professional growth. - Increased project gross profit margins from 20% to 25% through effective financial analysis and controls. - Built strong, trustworthy relationships with stakeholders, including clients, project teams, and management, by applying a “growth mindset” philosophy and prioritizing open and effective communication. - Achieved seamless integration of all participants in decision-making processes, ensuring timely identification and resolution of risks or issues. - Provided regulatory expertise, facilitating the management and success of internal and external audits over a two-year period.

Consultancy and support for local regulatory system update on medical device postmarket surveillance by transferring the “know how” and knowledge of the international regulatory and operative trends from the life sciences industries.• Process optimization to release administrative load from the post-market surveillance division of this regulatory entity.• Advice for the writing and review of the update project of the official Mexican rule for the installment and operation of post-market surveillance (PROY-NOM-240-SSA1-2018), and its related administrative guidelines.• Operative support in the assessment and statement of procedures related to the periodic post market surveillance report, adverse events notification, following and close of field preventive and corrective actions.

Consultancy to board for the development and implementation of the corporate strategy required for the expansion of the operations of this promising startup and its entrance at the international medical devices market.• Project planning for the design and implementation of the quality management system (QMS) according to the international regulatory standard requirements, to the internal capacity and operations of the company, as well as to the product features.• Approval from the directors’ board for the commercial/regulatory strategy defined after a full assessment of the company to choose the geographic regions for a product launch, and to define the stages and procedures to assure its viability.• Advice and operational support in local and international supplier qualification and selection.

Work with a multi-disciplinary team for definition, implementation, and maintenance of a regulatory-commercial strategic plan to enter and grow in the medical device global market, to ensure compliance with local and international applicable regulations, to guarantee the best quality of company products, the satisfaction of our clients, and to identify new business opportunities.

Design and execution of a marketing study to set the business development strategy and bioinformatic services portfolio gaining the approval from the directive board for the international expansion project.• Identification and segmentation of 200 potential clients, competitors, and partners in a market valued at two billion U.S. dollars.• Advising for the management team resulting in the approval from the board of directors of the expansion project with an estimated ROI of two million U.S. dollars in two years.• Use of effective negotiation and client service for the approval and agreement for an additional project for the determination of the corporate strategy for market penetration.

Compliance assessment and definition of CAPA plan to ensure compliance with FDA CFR 21, Chapter I, Subchapter H and ISO 13485 for medical devices for human use.• Lead the multi-functional team for the definition and implementation of the strategic commercial plan for diversification and identification of new business opportunities in the medical devices U.S. market concluding in obtaining FDA approval for two new business lines from FDA in 3 months.

The technical part of the dual pivotal role I played for company's founding team to establish LATAM divisional branch ensuing installment of Mexico legal entity. Reported to LATAM Office Manager Directors. - Achieved and completed 26 successful GxP Compliance projects in 10 different countries including some for leading life sciences industry enterprises such as Silanes Group, Fresenius Kabi-Novapharma, MOHES Group, LACER, INKE INVENT FARMA, TEVA PHARMA, TEVA Tapi, Merck Group, Baxter Healthcare Ltd. Gambro, FERMIC, INTERQUIM, MAPRIMED-CHEMO Group, Droguería INTI, Laboratorios Sophia, Farmacéuticos Maypo, between others and for regulatory entities as COFEPRIS and ARCSA. - Solved compliance GAPs relying on an associated risk analysis by promoting cross communication with client project teams, succeeded in optimizing targeted quality assurance systems. - Developed and implemented an accelerated learning training program for the local project team in computer system validation and biotechnology for full coverage of client requirements. - Led various interdisciplinary and international project teams for completion of specialized of specific GxP compliance remediation projects to acquire sanitary GxP certification from local or international regulatory entities.

The commercial part of the dual key role for company's founding team to establish LATAM divisional branch ensuing installment of Mexico legal entity. Reported to Global Business Development Director. - Defined and executed regionally focused business development strategy in an expansion of client portfolio by 110% in 2 years.- Trained specialized sales force composed of 3 multi-skilled professionals for each LATAM region.- Engaged local specialized professional associations and regulatory entities to foster strategic relationships resulting in a successful brand positioning and active influence for local GxP regulation update according to global trends.- Sales Management Mexico, leading the negotiation and closing of functional, technical projects with the life science industry.

- Technical and scientific sales promotion of pharmaceutical products:A) Pain Portfolio (Average coverage of 110% share of sales and 42% average rate of market share for the leading portfolio brand )B) Specialty Support Sales Force - Vaccines, Cardiovascular and Pain mixed portfolio, (Average coverage of 98% share of sales in leading portfolio brands)- Negotiation of placement and displacement of pharmaceutical products in public sector hospital and pharmacies, franchise, and independent pharmacies.- Business contact, management, and product return authorization at an authorized pharmaceutical dealer (DISTRIBUIDORA CASA SABA S.A. DE C.V.)- Planning and execution of medical, continuous education events.

- Defined a sustainability development plan for Earth Closet (E.C.) project according to Mexican environment regulatory framework to assess product final design features and commercialization viability.

- Designed project methodology to analyze the role of β–tubulin protein isoforms in human neuronal cytoskeleton and its association with bipolar disorder and schizophrenia. - Trained laboratory staff in molecular biology techniques, use, and maintenance of specialized equipment to develop and execute related scientific research projects.