Experience

LIM Global Consulting, S.L.

• Spain
• Hospitals and Health Care
• 1 - 100 Employee

• Project Manager

  • Dec 2019 - Present

  • Management and oversight of all clinical aspects of the study in accordance with internal SOPs, ICH, GCP, relevant guidelines and all applicable laws and regulations. • Oversight of all aspects of the study to ensure agreed study deliverables are met to the appropriate quality. • Responsibility for preparation of study documentation and coordination of document review, e.g. protocols, IBs, DSURs, ICFs, CSRs. • Selection and oversight of assigned CROs, vendors or contract monitors (CRAs), as appropriate. • Selection of suitable clinical sites • Periodic co-monitoring with contract CRAs or CROs, as necessary, to ensure high quality monitoring and site management. • Set up and management of clinical contracts (including Clinical Site Agreements). • Coordination of IRB/IEC and other required study submissions, and provision of essential documents to our regulatory consultants for regulatory submissions. • Preparation of study budgets, forecasting and accruals. • Thorough documentation of study team activities, decisions, actions and risk assessments. • Active management of clinical trials supply requirements. • Oversight of TMF creation, to ensure ‘inspection readiness’ of documentation at all times. • Develop and maintain relations with KOLs. Show less



DOCS

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regional Clinical Trial Manager

  • Apr 2016 - Apr 2019

  • Lead and manage the conduct of clinical trials from study start-up to closeout across multiple countries in accordance with ICH-GCP and applicable local regulations • Collaborate with other Regional Clinical Trial Managers (RCTM) and the Global Clinical Trial Manager (GCTM) for global execution of study(ies) • Maintain the quality and scientific integrity of clinical trials across multiple countries • Collaborate with cross-functional internal and external stakeholders to ensure timely and on budget execution of clinical trial deliverables within the region • Leading the regional matrix team (e.g. CRA, CTA, etc.) to ensure delivery of country and site level study activities in alignment with the global study project plan • Identifying and resolving issues at a regional level • Collaborating with Global CTM to ensure country level study delivery is aligned with the global study project plan • Contributing to study-level risk assessments • Leading and continually review regional risk mitigation activities to ensure study delivery to plan • Overseeing regional insourcing/outsourcing partner deliverables to the required standards Partnering with Tech Services, Supplier Governance and Electronic Trial Operations - to ensure regional, country and site vendor set-up, conduct and quality Leading regional documentation and required tool and systems set-up • Contributing to regional aspects of Drug Supply Plan • Ensuring implementation of study(ies) in accordance with SOPs and ICH/GCP guidelines Show less



Covance

• United States
• Research Services
• 700 & Above Employee

• Clinical Operations Manager

  • Feb 2015 - Mar 2016

  working under contract with Merck Sharp&Dohme with the following task:• Accountable for local operational clinical trial activities at country level in the following areas:• Deliver Ethic committee /Health local submission for study protocol approval at country level, managing and development local language Informed Consents and translations. • Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements Oversight and tracking of clinical research-related payments. • SME in FCPA process. Contributes to the development of local SOPs.• Responsible for managing country deliverables focused mainly at site ready and close out period.• Works in close collaboration internally with country operations internally and across several departments as well with Regional Operations.• Oversight and coordination of local processes, responsible to update the country information in clinical, regulatory, safety and finance systems. Show less

• Senior Clinical Research Associate

  • Aug 2011 - Feb 2015

  working under contract with Merck Sharp&Dohme with the following task:• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned• Manage projects as lead monitor under direction of a client Project Manager• Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy• Prepare accurate and timely trip reports• Territory management (new potential investigator team in my region) Show less



Harrison Clinical Research, Spain

• Barcelona

• CRA

  • Sep 2006 - Apr 2009



Organon

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Laboratory Technician

  • Mar 1997 - Dec 1998

  Validation of analysis methods of pharmaceutical products.; Quality control of raw material and final product; Environment control of active components (hormones); Water validation. Validation of analysis methods of pharmaceutical products.; Quality control of raw material and final product; Environment control of active components (hormones); Water validation.