Clinical Research Associate & Study Coordinator Trainee

• Jun 2023 - Present

Rare Condition Partner

• Jul 2021 - Feb 2023

• Accountable for developing and executing the Country Business Plan that supports the strategic operating goals in Rare Diseases.• Develop local medical strategies aligned to business goals including but not limited to pre-launch, launch and postlaunch activities.• Collaborate with global teams (through work packages) and/or other RCPs in developing and executing common pinpoint solutions.• Establish and maintain liaison with KOLs and scientific societies through Research Grants, Publications and Scientific projects.• Establish and maintain liaison with patient associations through medical education and patient support programs.• Initiate and support high impact medical education activities, such as advisory boards, congress symposia, hospital meetings and speaker development programs.• Raise Rare Disease awareness through co-creation meetings with internal and external stakeholders.• Provide scientific support to Marketing, Regulatory, Market Access, Pharmacovigilance and Risk Management groups.• Prepare and submit quarterly reports to Medical Director and General Manager. Sometimes present reports (data) during townhalls and/or to the Leadership team.• Comply with the budget assigned.• Partnering with the SMA community and healthcare ecosystem to remove roadblocks.• Gathering and Sharing insights from the SMA community and healthcare ecosystem, prioritizing and securing resources as needed and find solutions that deliver outcomes, faster. • Strategic planning and execution through agile methodologies like scrum, sprints, and kanban.• Execute processes (SOPs) within Medical Compliance while using a wide range of systems that include material review and approval (veeva vault), medical information (SAP), MI quality assessments, field visit tracking (OTR), global tools for international speaker request, among many others.• Manage Patient Support Program for SMA population. Show less

Portfolio Medical Advisor

• Oct 2020 - Jul 2021

• Providing medical and scientific input to the leadership team• Contributing medical expertise and providing guidance/training to internal stakeholders • Performing administrative duties and risk management• Performing market research for different therapeutic areas• Performing patient journeys• Managing allocated budgets• Keeping informed on advancements in the field and contributing to strategic plans• Ensuring compliance with healthcare regulations and safety standards.• Coordinating advisory boards and round tables• Designing, setting up and delivering accredited further training and leading medical and marketing projects• Co-create local SOPs for Early Access Program Implementation Show less

Medical Science Liaison - Oncology Field

• Dec 2016 - Oct 2020

• Developing and maintaining peer-to-peer collaborations and relationships with key medical experts (KOLs)• Supporting clinical development initiatives including site identification, trial recruitment, registry, and presentation of final approved data • Collaborating with physicians on medical affairs initiatives including publications, advisory boards, medical education opportunities, training, and speaker development • Serving as scientific peer-to-peer resource to external disease experts and internal stakeholders • Supporting the medical community with up-to-date medical information, robust disease expertise, and product information • Communicating clinical insights on new data to the company Medical Affairs and to inform medical strategy for the therapeutic area • Training internal stakeholders on key scientific and medical topics in relevant therapeutic area • Developing an understanding of the country landscape including specialties involved in care of patients • Maintaining effective and appropriate communication among internal stakeholders while maintaining full compliance with relevant requirements • Generating tactical regional plans to provide needs based, value-added support of the medical and scientific community in-line with company goals • Using systems to strategically map, identify, profile and prioritize thought leaders in line with the medical plan and goals • Maintainig accurate reporting and documentation of MSL activities• Support the annual business plan Show less

Market Research & Patient Support Programs (MAP) Lead

• Sep 2015 - May 2017

• Responsible for Pharmacovigilance (PV) compliance of Market Research and Patient Support Programs (MAP)• Ensuring MAPs are conducted in compliance with global and local regulations and procedures• Partnering with Operations Vendor Management to oversee and support the activities performed by vendor (TCS) staff for MAP related PV activities including PV Approval of the MAPs, case transmission verification (CTV), source data quality check (SDQC) and case collection• Oversight, education and training of Service Providers conducting MAPs on Roche's behalf • Ensuring all dedicated systems and tools on which the process rely are effectively maintained and updated. • Act as deputy to the MAP PV Responsible during his/her absence and will partner with the Roche commercial function in the field of the MAP safety.• Achieving excellent levels of program compliance. Representing PDS Operations at forums and carrying out discussions with service providers, communicating accountabilities, deliverables and results. Show less

Drug Safety Analyst - Pharmacovigilance

• Mar 2015 - Dec 2016

• Ensuring the rapid and timely processing and managing of new and follow-up reports of adverse events (AEs) and side effects, as well as serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs)• Reporting AEs and side effects to the EMA,Ecuadorian authorities and – if these arise from clinical trials – to ethics committees and Drug Safety Management Boards (DSMBs), and steering committees of the respective clinical trials• Processing all the AEs, SAEs and SUSARs in the Global Safety Database according to the applicable company policies and Standard Operating Procedures (SOPs), and as required by the Ecuadorian and European Authority for reporting adverse events• Contacting those who reported the AEs and side effects to obtain complete information for analysis• Ensuring that assessments are carried out according to AE, SAE and SUSAR criteria and forwarding eventual AEs/SAEs and SUSARs to the head office• Contributing to keep local processes, procedures and systems up to date and assisting with, and participating in, audits and inspections when these arise.• Translating and reviewing translations from English to Spanish of technical documents such as PBRERs, DILs, TWIMCLs, DHCPs, etc. Show less

General Practitioner

• Jul 2014 - Dec 2014

• Provide health care to all patients who come to the hospital emergency department, with the means available at their disposal, collaborating with the rest of the hospital services in emergency care• Decide the admission of patients to the hospital when their clinical situation so advises, in accordance with the procedure established in each center• Discharge the patient from the emergency service once attended and with the corresponding clinical report• Inform the patient and/or, where appropriate, their relatives of their clinical process, complementary examinations, treatment and planned actions, as well as other aspects that affect the evolution of the process.• Decide and organize, under ideal conditions, the transfer of patients who require it, from the emergency service to other hospitals with a larger portfolio of services or when the care circumstances advise it.• Make the reports established by current legal regulations, where appropriate.• Supervise the development of the assistance and training process of the personnel under their charge.• Appropriately manage the resources assigned for the sake of greater effectiveness and efficiency.• Participate in the development and maintenance of the center's information systems and those related to its activity.• Participate in research programs, in the training plan and in quality improvement activities specific to their specialty.• Cooperation and coordination with the rest of the care devices for urgent health care. Show less

Country Doctor

• Jun 2013 - Jul 2014

• Assistance: Implement health programs, curative and preventive medical care within the outpatient clinic• Administrative: Prepare epidemiological reports and outpatient requisitions• Social: Participate in the community not only as a professional but as an inhabitant• Educational: Offer informative talks on health in schools, high schools, shelters and the clinic • Researcher: Identify public health problems and issues of health interest in the community• Medical-legal: prepare birth and death certificates, justifications for absence from work and forensic reports• Supervision: Assess the quality of food and beverage outlets, school canteens, as well as the management of cattle during their vaccination and benefit. Show less