Gemma Estrada Bertran Email & Phone Number

Barcelona, Ct, Es

Barcelona, San Francisco, San Sebastián, Es

Analyse early stage concepts, evaluate, mentor, technology transfer, business strategy, clinical strategy, and operations. BHV (Barcelona Health Ventures) is a start-up builder in the digital health/medical device/biotech space.

Barcelona, Es

Transform Ferrer’s products and services by partnering with tech start-ups and patient communities. Ensure integration of patient’s perspectives to enhance product relevance and effectiveness. Facilitate the development and execution of strategies in digital health to meet Ferrer’s objectives. • Conceived and deployed the open innovation program Ferrer4Future https://ferrer4future.com/• Built and led a high-performing Digital Health team capable of effectively sourcing opportunities, identifying tech partners, and managing the development of digital health solutions.• Led the successful development and launch of Ferrer’s first CE-marked digital medical device by managing a large cross-functional team that included regulatory, clinical research, pharmacovigilance, data analytics, medical, marketing, market access, and sales departments, alongside technology developers from a partner start-up.• Identified over 1,000 emerging companies globally, and engaged with 400 that showed potential to transform Ferrer's products and services.

Barcelona, Es

Lead Ferrer’s Clinical Operations team in house and the external CROs to deliver studies on time and within budget. Interface with Regulatory, Drug supply, Pharmacovigilance, Medical and Market Access departments, as well as alliance partners. Contribute to discussions regarding adjustments in studies and strategy, based on emerging data. Help author protocols, amendments, IB, clinical sections of IND/IMPD fillings, annual reports, clinical study reports and risk management plans. Ensure study design feasibility and assist in the preparation of regulatory responses. Evaluate potential study sites from a scientific/strategic perspective.• Successfully passed FDA inspection of pivotal trial supporting registration of first Ferrer R&D product in US.

Barcelona, Catalonia, Es

Design and deploy the BCTP (Barcelona Clinical Trials Platform) to promote Clinical Research in Catalonia, following a mandate of the Health Department. Strengthen the capacity of Public and Private Research Institutes and expand their collaboration with pharmaceutical companies, CROs, government agencies, medical societies and, PAGs. Coordinate the construction of the IT backbone and data structures to connect research institutes and university hospitals (5.000 beds) with the platform. Enhance organizational productivity to offer Government health decision makers, industry sponsors, investigators and patients an efficiently managed research process.• Designed a pilot project in collaboration with genomics labs and supercomputing facilities to profile cancer patients across Catalonia and match them to either existing treatments or oncology clinical trials, ensuring equitable access.• Improved organizational productivity to provide an efficiently managed research process for government decision-makers, industry sponsors, investigators, and patients.

Morrisville, Nc, Us

Manage Spain, Italy, Portugal, Israel, Argentina, Peru, Mexico, and Chile for the CRO Synteract, Inc (today Syneos) to meet operational and financial targets. Ensure alignment with patient needs and regulatory standards, facilitating the involvement of PAGs in clinical trial recruitment and study design, integrating patient’s perspectives, contributing to regulatory filings and the development of clinical study reports. Working closely with Sales, Finance, and Controlling departments to prepare accurate business forecasts to ensure revenue growth and margin enhancement. Develop senior client relationships and contribute to the award of new projects driving cross pollination of opportunities and growth of accounts. • Developed senior client relationships, contributing to new project awards and growth of accounts, driving 20% revenue growth and 3% margin enhancement in the region.• Integrated patient’s perspectives in trial designs and ensured compliance with regulatory standards across geographies. • Mentored Country Managers across the region to strengthen leadership and performance

Morrisville, Nc, Us

Start the Spanish affiliate of the CRO Harrison Clinical Research (today Syneos) and grow it from scratch. Establish key commercial relationships with third parties and CRO partners in Portugal to build the overall Iberia operation. Run the Business Admin, Business Development, Sales, Public Affairs & Patient Advocacy, and Clinical Operations to meet performance and financial targets.• Contributed to overall 5X growth of CRO company in 12 years.

Paris, France, Fr

Monitor and Manager of Phase II-III international clinical studies, including the preparation of PEI documents (equivalent to IMPD), study submission to Health Authorities and Ethic Committees, selection of investigators, monitoring to FDA-ICH standards, preparation of internal / external audits, and negotiation of budgets with vendors.

Sant Cugat Del Vallès, Barcelona, Es

Clinical Research Associate for Phase I-IV Multicenter Trials, including feasibility studies, development of financial contracts with study sites, monitoring sites and phase I clinics in Spain, performing site monitoring visit assessments in the UK for studies contracted out to CROs.

Barcelona, Barcelona, Es

Lecturer and laboratory instructor in Biochemistry, Toxicology and Nutrition Science

We Health, Enterpreneurship In Health And Healthcare - Barcelona

Leadership And Marketing - Barcelona

Executive Management - Amp- Madrid

Research Fellow At New England Medical Center - Boston (Ma)

Visiting Felow At Academisch Medisch Centrum (Amc) - Amsterdam

Education record