About Adrián
Spanish
Native or bilingual
English
Fluent
Experience
- IndiviSenior Program ManagerMEDICALAugust 2022 - Today (3 years and 10 months)Basilea, SwitzerlandLeadership, management, and execution of multiple clinical trial programs,regulatory submissions(MDR & FDA), and acquisitions (BDH from Biogen to Indivi):- Clinical trial for people with Multiple Sclerosis using the dreaMS MedicalDevice in collaboration with USB Hospital in Basel (RC2NB) and Roche(budget over 5M€)- Clinical trial for people with Schizophrenia in collaboration with Northwell(USA-based clinical trial)- Clinical trial for people with Parkinson's in collaboration with Biogen(Worldwide-based clinical trial, budget over 10M€)--Tasks & Responsibilities:- Lead the coordination of all activities related to medical devices in clinical trials.- Serve as primary liaison between clinical teams and medical device vendors, managing incidents and inquiries to optimize responseacross the entire study portfolio, as well as to procure, track, and maintain necessary inventory materials.- Coordinate with regulatory teams to ensure compliance with healthcare software regulations (e.g. MDR, FDA, GCP, ISO 13485, etc.).- Implement and maintain quality management processes (e.g. SOPs & WIs) in accordance with medical device software requirements.- Lead change management initiatives for medical software updates across multiple healthcare facilities.- Coordinate the development of training materials on device usage for clinical staff.- Collaborate with internal teams and external stakeholders to maintain medical device requirements as agreed in study protocols.- Monitor device performance during trials and report on effectiveness and safety.- Implement risk management and mitigation strategies for device-related issues in clinical trials.- Assist and lead related processes for the rebranding from Healios to Indivi and M&A of BHD from Biogen to Indivi.--Technologies:Jira, Confluence, Trello, Slack, Azure DevOps, AWS, Smartsheet, PowerBI, GSuite, GreenLight Guru, SharePoint, etc.
- Grupo MendraPresidentTECHJuly 2020 - Today (5 years and 11 months)Málaga, SpainHolding company focused on business tech development solutions:- Mendra.co: Business accelerator firm | Main client: Indivi.io- Wonders.Travel: Adventures that tie bonds for life | Travel agency- Dronatic.es: Aerial filming, photography, and audiovisual company- Farug.net: Handmade and unique Traditional Persian Rugs E-Commerce--Tasks & Responsibilities:- Work closely with the Co-Founders to define the company strategy and operations- Make and sign agreements, having meetings with key stakeholders- Control and lead company milestones, contracts, etc.--Service Level Management & Financial Operations:- Design and implementation of Service Level Agreements (SLAs), Service Level Objectives (SLOs), and Service Level Indicators (SLIs) across multiple clinical programs and vendor relationships.- System optimization and performance monitoring through established KPIs and metrics.- Management of multi-currency operations and budgets (CHF, EUR, USD) for international clinical trials and vendor contracts.- Strategic planning and execution of service improvement initiatives to enhance operational efficiency.--Technologies:Trello, MS Office, Slack, Confluence, etc.
- ERNISenior Project Manager & Service Delivery ManagerTECHMay 2021 - March 2023 (1 year and 10 months)Barcelona, SpainDevelopment & Maintenance of Cobas Infinity POC (iPOC) worldwide:- Service Delivery Manager at ERNI for iPOC Roche project (+1M€)- iPOC Product Care Team Lead- Scrum Master & Agile Coach--Tasks & Responsibilities (Project Manager & Service Delivery Manager):- Ensure the quality of the service according to the SLAs of the project- Take actions and mitigate possible risks of the project- Build and maintain customer relationships- Work closely with the Program Manager- Manage project resources and budget- Generate monthly reports, etc.Tasks & Responsibilities (Team Lead, Scrum Master & Agile Coach):- Develop best practices and tools for the project execution and team delivery- Facilitate Scrum ceremonies and liaise with different Stakeholders- Plan and schedule project milestones using appropriate tools- Resolve possible impediments that the team could have- Plan meetings and document meeting notes- Organise team-building activities, etc.--Technologies:Azure DevOps, HP ALM, Trello, Confluence, Slack, Mural, GSuite, MS Office, etc.
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Education
- Máster en Ingeniería IndustrialUniversidad de Málaga2018
- MBAThe Power MBA2020