Experience

GBA Group Pharma & Medical Devices

• Germany
• Public Health
• 1 - 100 Employee

• Project Manager, Deputy Head and PBMC Team Lead

  • Oct 2021 - Present

  • Supervise a small team of project managers and laboratory development managers.• Oversee the planning and execution of clinical trials, including resource allocation, budgeting, and accounting.• Expand the laboratory network by selecting, subcontracting, audit, and training laboratories to ensure the quality of delivered clinical trial samples (Peripheral Blood Mononuclear Cells (PBMCs), and other human specimens) per Sponsor-specific requirements and sample processing procedures for each clinical trial.• Implement and improve scientific manuals, SOPs and protocols, in compliance with GxP quality systems (GCP, GLP, GDP)• Serve as a liaison between sponsors, sample processing laboratories, and other stakeholders.• Provide scientific support and troubleshooting to laboratories.• Hire, onboard, and train new employees.• Develop and maintain project-specific Laboratory Information Management Systems (LIMS) and electronic Sample Data Sheets.• Ensure proper documentation requirements for clinical studies.• Establish effective communication channels between clinical investigator sites, sample processing laboratories, central analysis laboratories, logistics partners, and other contractors.• Monitor quality data and initiate corrective and preventive actions.• Purchase laboratory supplies and coordinate the production of sample collection and sample processing kits and labels.• Monitor project finances and prepare monthly project accounts.• Supervise national and international clinical trials in cooperation with clients from the pharmaceutical industry.• Ensure compliance with Standard Operating Procedures (SOPs). Show less

• Project Manager PBMC, Deputy Team Lead

  • Aug 2021 - Oct 2021

• Project Manager IMP and PBMC

  • Mar 2020 - Aug 2021

  • Coordinated GMP-compliant primary and secondary packaging.• Prepared, documented and maintained study-specific documents.• Managed clinical and non-clinical studies according to legal, GCP, GMP and protocol requirements.• Communicated, organized and monitored internal and external partners within a project and implemented the projects on an international level.• Cooperated closely as the main contact person of international study teams and contract partners.• Was responsible for compliance with Standard Operating Procedures (SOPs).• Accounted for projects and monitored the project budget.• Managed the logistics of clinical trials, including the coordination of shipments, packaging, and documentation.• Developed and maintained project-specific Laboratory Information Management Systems (LIMS) and electronic Sample Data Sheets.• Ensured proper documentation requirements for clinical studies according to GCP, GCLP, GDP/GMP.• Established effective communication channels between clinical investigator sites, sample processing laboratories, central analysis laboratories, logistics partners and other contractors.• Monitored quality data and initiated corrective and preventive actions.• Purchased laboratory supplies and coordinated the production of sample collection and sample processing kits and labels.• Prepared and reviewed logistics plans, sample preparation manuals or laboratory instructions.• Supported global lab search, audit, training, certification activities at sample processing laboratories.• Prepared and reviewed contracts with sample processing laboratories.• Monitored project finances and prepared monthly project accounts.• Supervised national and international clinical trials in cooperation with clients from the pharmaceutical industry.• Planned and coordinated medication logistics for international studies in compliance with the required regulations. Show less



Celerion

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Contract Manager II and European Data Privacy Officer

  • May 2016 - Feb 2020

  • Contract Manager II o Drafted, reviewed, negotiated, and finalized agreements with pharmaceutical companies, clinical study sites, and vendors, including confidentiality agreements, budgets, and payment schedules, as well as other related agreements. o Drafted and reviewed agreements according to company policy, rules, practices, and procedures, and implemented and managed the process for internal and external approval and execution. o Identified and assessed legal, financial, and operational risks in contracts and provided recommendations and alternative resolutions. o Liaise and established effective relationships with clients. o Identified and assisted with the implementation of process improvement opportunities. • European Privacy Officer o Implemented and maintained the company's privacy program, including the development and implementation of policies and procedures, training of employees, and responding to data subject requests. o Conducted privacy impact assessments for new and modified projects and processes. o Monitored and reported on the company's compliance with data protection laws and regulations. o Represented the company in data protection matters with regulators and other stakeholders. Show less



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Senior Purchasing Coordinator, EMEA

  • Apr 2015 - Apr 2016

  • Oversaw the extraction of spend data from accounts payable or other databases and created spend reports in various formats. • Prepared data templates for creation of baselines and provided templates to vendors to populate with line item spend details. • Worked with functional stakeholders to identify requirements, identify sourcing process steps and project timetable, and prepared Request for Information or Request for Proposals documentation. • Analyzed bids and prepared comparative analysis to support evaluation decisions. • Researched vendor information and suitability to satisfy Professional Service Centre (PSC) request to approve new vendors. • Created and populated templates required for eSourcing exercises and assisted in setting up online auction events. • Ensured purchase orders complied with contract terms and worked to improve the efficiency of the purchase to pay process. • Created purchase order requisitions in resident purchasing system as required. • Performed other duties as assigned. Show less



Sanofi Pasteur MSD

• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Legal Counsel, Contract Management Specialist

  • Apr 2013 - Feb 2015

  • Managed the administration of the contract database, including the approval process, negotiation, and drafting of various types of contracts (commercial, collaboration agreements, transportation, warehouse, consultancy, speaker agreements, clinical research, etc.). • Implemented the new SPMSD contract policy and ensured compliance with data protection law. • Educated SPMSD departments and other teams on contract terms and monitored compliance. • Responded to complex inquiries regarding contract obligations and revisions. • Identified risks and issues, suggesting alternatives that led to the best solution. • Reviewed and managed contractual obligations of the parties and provided continual review to ensure that all terms and conditions were met. • Verified the accuracy of billing that had been issued to ensure compliance with contracts. • Prepared and disseminated information regarding contract status, compliance, and modifications. • Acted as the primary contact between the project team and/or business unit and Legal, ensuring that all legal and contractual matters were addressed efficiently and promptly. • Ensured adherence to company policies and procedures by assigned Contract Management, project or business personnel. • Participated in different projects/committees, such as promotional materials, changing the corporate culture, and tenders. Show less



ANECA

• Education Administration Programs
• 1 - 100 Employee

• Monitoring and Evaluation Specialist (VERIFICA PROGRAM)

  • Apr 2009 - Jan 2014

  • Verified and accredited university degrees in Spain as part of the VERIFICA Programme.• Assessed the quality of university degree projects submitted by universities.• Worked with universities to improve the quality of their degree programs.• Gained valuable experience in quality assurance and accreditation.• Developed strong research, writing, and analytical skills.• Worked closely with experienced professionals and gained a deep understanding of the quality assurance process.• Successfully completed all assigned tasks and met all deadlines.• Demonstrated a strong commitment to excellence and a willingness to go the extra mile. Show less

• Monitoring and Evaluation Specialist (MONITOR PROGRAM)

  • Jan 2012 - Dec 2013

  • Monitored and evaluated the implementation of university degrees in Spain as part of the MONITOR Programme.• Provided regular external appraisals to universities on the quality of their training programs.• Worked with universities to improve the quality of their training programs.• Gained valuable experience in quality assurance and accreditation.• Developed strong research, writing, and analytical skills.• Worked closely with experienced professionals and gained a deep understanding of the quality assurance process.• Successfully completed all assigned tasks and met all deadlines.• Demonstrated a strong commitment to excellence and a willingness to go the extra mile. Show less



RODRIGO ABOGADOS

• Spain
• Law Practice
• 1 - 100 Employee

• Junior Lawyer

  • Sep 2012 - Apr 2013

  • Provided legal advice and representation to clients in a variety of matters, including commercial law (corporations), civil law (contracts, family relations, torts and claims), criminal law, and real estate. • Gained valuable experience in the legal field and developed strong research, writing, and analytical skills. • Worked closely with experienced lawyers and gained a deep understanding of the legal process. • Successfully completed all assigned tasks and met all deadlines. • Demonstrated a strong commitment to excellence and a willingness to go the extra mile. Show less



Airbus Defence and Space

• Defense and Space Manufacturing
• 700 & Above Employee

• Legal Intern

  • Sep 2011 - Aug 2012

  • Provided support on a variety of legal matters, including claims and litigation, contracts, data protection law, public tenders, insolvency proceedings, cost proposals, and database legislation. • Gained valuable experience in the legal field and developed strong research, writing, and analytical skills. • Worked closely with experienced lawyers and gained a deep understanding of the legal process. • Successfully completed all assigned tasks and met all deadlines. • Demonstrated a strong commitment to excellence and a willingness to go the extra mile. Show less



Francisco Lucas Lucas, Attorney at Law

• Guadalajara, España

• Legal Intern

  • Jul 2008 - Sep 2008

  • Assisted with all legal proceedings, including research, drafting documents, and attending court hearings. • Provided support to clients, including answering questions, scheduling appointments, and preparing documents. • Successfully completed all assigned tasks and met all deadlines. • Demonstrated a strong commitment to excellence and a willingness to go the extra mile. • Assisted with all legal proceedings, including research, drafting documents, and attending court hearings. • Provided support to clients, including answering questions, scheduling appointments, and preparing documents. • Successfully completed all assigned tasks and met all deadlines. • Demonstrated a strong commitment to excellence and a willingness to go the extra mile.