Hector De Lille

T

Clinical Trial Liaison

The Medical Affairs Company (TMAC)

Aug 2022 - Jul 2023 (1 year)

(Mexico, Colombia and Peru). Provide country/regional operational insight into site feasibility and selection and overall patient recruitment strategy. Participate in Clinical Study Team Meetings and Quality Review Meetings where necessary providing input to study teams on operational issues based on site visits and contacts. Attend and present at investigator meetings, monitor workshops/training. Participate in site visits with investigator site staff and/or CRO representatives, or independently, in support of clinical trial execution and report back to study teams e.g. feasibility, startup activities, enrolment or escalated study/site issues. Responsible for review, documentation and follow up of investigator site issues including trackin

Sr Clinical Trial Educator

IQVIA

Feb 2022 - Feb 2023 (1 year 1 month)

Provide practical support to study sites to maximize potential for patient enrolment. Work with research sites to identify and address recruitment barriers – identify common site issues and work with the sponsor and relevant stakeholders to recommend creative options to overcome these barriers. Provide on-going training and information on the clinical trial inclusion and exclusion criteria to the study team, where required conduct training for new study staff. Act as a resource for healthcare professionals at clinical study sites by sharing best practices and strategies for patient identification and retention. Conduct recruitment training sessions. Identify patient flow / pathway through the site and work with identified departments to rai

Sr Project Manager/Global Operations

Worldwide Clinical Trials

May 2019 - May 2020 (1 year 1 month)

(US and Latin America). Responsible for the overall coordination and management of clinical trials from start-up through closeout activities in specific Therapeutic Areas (Business Unit). Direct the technical, financial and operational aspects of the projects -- thus securing the successful completion of clinical trials. Work with major functional area leads to identify and evaluate fundamental issues on the project, interpret data on complex issues, make good business decisions and ensure solutions are implemented. Work to ensure that all project deliverables meet the customer's time/quality/cost expectations. Collaboration with other functional area leads, for ensuring that all project deliverables meet the customer/contract expectations.

A

Regional Monitor as Contractor

Actelion Pharmaceuticals

Aug 2018 - Aug 2025 (7 years 1 month)

(Mexico, Guatemala, Colombia, Peru, Chile). Training to Sites: Principal Investigators, Sub Investigators, Study Coordinators. Training to Monitors team: Sr CRAs, Jr CRAS. Feasibility Elaboration. Regulatory Process Elaboration (translation/adaptation of documentation, preparation of regulatory packages, regulatory submissions). Including Local and Central IRBs, MoHs. Regulatory affairs: New Products Registration; Renewals of Registries; Regulatory Requirements Validations. Design of protocols, patient information sheets and consent forms. Elaboration of Pre Study Visits, Initiation Visits, Monitoring Visits, Close Out Visits. Safety/Security of all the ongoing clinical trials (Cardiology, Pneumology). Phase III/IV. Review and verify CRFs a

B

Medical Affairs Manager/Medical Affairs Advisor

Boehringer Ingelheim MexicoPROMECO SA DE CV

Oct 2012 - Sep 2015 (3 years)

for Mexico, Central America and Caribbean. In charge of all OCT/CHC franchise medical affairs: Products in different OTC/CHC therapeutic areas. In charge of specific PM products medical affairs. Responsibilities: Medical Information Review/Updating of all Company assigned products. Development/Updating of Prescription Information (IPP), CCDS of all related products. Development of Medical Dossiers for new products launching. Review of all marketing material related to products from Medical view. Preparation of all scientific support for all regulatory topics related to assigned products. Accountable for the overall delivery of the assigned product(s) Medical Plan. Lead Medical Managers colleagues working on the company to develop annual med

M

Lead Regional Monitor/Project Manager

MAS-CLINICAL CRO

Mar 2011 - Oct 2012 (1 year 8 months)

(FREELANCE POSITION). Project Management. Training to Sites: Principal Investigators, Sub Investigators, Study Coordinators. Training to Monitors team: Sr CRAs, Jr CRAS. Feasibility Elaboration. Regulatory Process Elaboration (translation/adaptation of documentation, preparation of regulatory packages, regulatory submissions). Including Local and Central IRBs, MoHs. Regulatory affairs: New Products Registration; Renewals of Registries; Regulatory Requirements Validations. Design of protocols, patient information sheets and consent forms. Clinical Trial Documentation Validation (Protocol, IB, ICF, CRFs). Clinical Data Validation. Elaboration of Pre Study Visits, Initiation Visits, Monitoring Visits, Close Out Visits in multicenter internatio

C

Country Manager Mexico/Latin America

ClinTec International Ltd.

Sep 2008 - Nov 2011 (3 years 3 months)

Wordwide. Latin American Region. Developed all the paper work and follow up necessary to establish the legal entity in the different countries of the region. Preparation and submission of documents to obtain sanitary licenses alongside Latin America to be able to develop our clinical trials in the different countries. Management of the development of the operation in all the region (Clinical, Business, Finance, Regulatory, Human Resources, Quality Assurance). Feasibilities process for potential clinical trials. Project Management of ongoing clinical trials in the different countries, in the principal therapeutic areas. Obtaining of Import and Export licenses for drug and samples related to the clinical trials. Test Article Management. Proto

C

PM/Senior Clinical Research Associate/Auditor

ClinTec International Ltd.

Sep 2008 - Nov 2011 (3 years 3 months)

Project Management. Good Clinical Practice (GCP) training programs. Templates and Tracker elaboration. Protocol writing. ICF and Protocols revision and translation. Site contact. Acquire site documentation (CDA and Feasibility). Acquiring and fulfilling site specific documents (FDA1572 form, financial disclosure form, delegation log, laboratory certification and normal ranges, site visit signing log form, site initiation form, identification and statement of third part unbinding, subject master list, protocol approval page, IRB acknowledge of IB receipt, stamped ICF, questionnaires, diaries, IRB approval letter, certificate of insurance, and other company specific forms). Preparation of study Start-up files. Preparation of regulatory submis

I

Independent Clinical Research Specialist

Jan 2004 - Current (22 years 6 months)

As Independent Clinical Research Specialist I have participated in more than 50 multicenter international clinical trials phase I-IV, providing clinical research full services to Pharma and Biotech Companies (Project Management, Medical Monitoring, Clinical Research Monitoring, Regulatory, Auditor, Business Development, Finance and Contracts, Marketing) in the development of their projects through all Latin America Region: Development of Project Management and Scope of Work Plans. Certified Auditor: GCP, GLP, GPV, GMP (Validations and Accreditations). Clinical Research Projects related to Clinical Research Sites, CROs, Vendors and Providers. Medical Monitoring. Participation in Elaboration of Project Proposals, Budgets/Contracts Elaboration

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Clinical Research Associate Senior

Latin American CRO MMATISS

Jan 2004 - Aug 2008 (4 years 8 months)

Led International Projects Controlling all the Clinical Operation of all 12 countries. Participated in 25 international Projects having the results according with the expected timelines, following all the international Procedures and Standards. Preparation and submission of regulatory Packages for clinical Trials Authorization alongside Latin America (EC/IRB, MoH). Development of feasibility programs in all the Latin American Region, for different therapeutic areas. Protocol Writing. Management and Monitoring of Sites, International and Multicenter Studies in Osteoporosis (Adverse Events re-monitoring), Infectology – Pneumonia (Phase II – 8 sites), Psychiatry Insomnia (Phase III – 10 sites), Ophthalmology – Glaucoma (Phase III – 10 sites),

L

Global Business Development Manager

Latin American CRO MMATISS

Jan 2004 - Aug 2008 (4 years 8 months)

All Latin American Region 12 countries. Led all the Global Strategies to be awarded with International Projects to be performed in the region (including all Phases 1 to IV). Led and developed all the SOPs and Procedures Manual related to the Development of Business in Latin American Region. Established contact with more than 120 new clients reaching the expected number of projects per year with an increase of 100% per year. Led the Development of Clinical trials around Latin America with the most important Transnational Pharmaceuticals, having a extra exponential growth in sales of 300%. Managed all contract negotiations, financial, proposals, budgets, logistics, treasury, and import/export activities. Performed all the Marketing & Financia

H

Adscript Physician

Hospital Escandon Hospital Gea Gonzalez Grupo Angeles

Jan 2003 - Dec 2008 (6 years)

Led the improvement in the general services of the different area, making the development of the standard procedures in each one: ICU, Internal Medicine, Pediatrics, Surgery, ER, Gynecology, Clinical Research.

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