Manuel Salinas Email & Phone Number

Mexico City, Mexico

Mexico City, Cdmx, Mx

• Manage clinical protocol Phase I, II, III and IV at the Local or Regional level and processes associated with the stages of pre-study, initiation, recruitment and closure of research centers, ensuring compliance with the metrics established for each clinical study.• Responsible for pre-selection activities and administrative processes of clinical studies in México and Latam.• Responsible for the pre-selection and final selection to the centers.• Based on the general budget for a clinical study, prepares and negotiates the budget of each investigator and/or research center, ensuring the generation the contract until is signed by all parties• Generates the operational documents of the study, participating in the review of the protocol, informed consent, material for the subject and documents that include Monitoring Plan, Selection Letter, Letter of invitation to the Meeting of Investigators, etc.• Participates in the generation of the e-CRF that will be used in the study and training the assigned CRA.• Requests material and investigational product that will be required to carry out the project to clinical logistic area.• Responsible for managing the monitoring and administration process of clinical studies in Mexico and Latam.• Responsible for the research centers complying with all regulatory and resource requirements.• Conducts the quality visits to ensure the proper conduct of the study.• Follow up the study through the authorization monitoring visits, review and approval monitoring reports, including external CRA.• Ensures that all deviation findings are resolved in a timely manner.• Responsible for the verification and closure of the database in a timely manner.• Participates in the review of the final report of the clinical studies.• Evaluating the performance of research centers through monitoring reports.• Facilitate and improve the conduct of clinical protocol and improve the internal processes of the Department of Clinical Operations.

• Evaluating the quality and integrity of study site practices related, provide monitoring visits and manage Investigator sites, as required by the study in adherence with GCP and ICH guidelines.• Verifying appropriate inform consent procedures and ensure subjects welfare and safety.• Dealing effectively with data queries by providing site staff with information and advice on query resolution.• Performing all in-house, on-site monitoring visit types. Initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.• Escalating quality issues to clinical team lead or manager.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment case report form completion and submissions and data query generation and resolutions, providing site staff with information.• Creating and maintain appropriated documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.• Responsible for training the investigators and site staff about the clinical study procedures.• Conducting site monitoring visits according the planned budget specified in the contract• CRA participated on the data lock for the study.• Reviewing the data collected in order to assure its integrity and validity.• Preparing and performing Investigator Payments.• Writing and correcting ICF for studies• Recollecting and update electronic TMF• Contact potential investigator to invite them to new trials.• Conduction of feasibilities.• Reviewed and verification SAEs and AEs.

Ciudad De México, México

• Prepare the topics of the subject, attending to the approved study plan, and present it to the students.• Identify the individual learning and behavior needs of each student.• Develop, apply and correct evaluation methods, such as presentations, group work.• Keep detailed records regarding the individual progression of each student, to ensure that the student achieve adequate progress and meets the established objectives.• Watch over the personal and social development of the students.• Guarantee that the educational institution complies with safety and teaching standards.

Ciudad De México, México

• Prepare the topics of the subject, attending to the approved study plan, and present it to the students.• Identify the individual learning and behavior needs of each student.• Develop, apply and correct evaluation methods, such as presentations, group work.• Keep detailed records regarding the individual progression of each student, to ensure that the student achieve adequate progress and meets the established objectives.• Watch over the personal and social development of the students.• Guarantee that the educational institution complies with safety and teaching standards.

Mexico City Area, Mexico

• Planning, organizing, monitoring and evaluating the personal on my charge• Evaluating the quality, service and efficiency of the laboratory equipment. • Maintaining update the curricular documentation and train the personal on my charge.• Evaluating the work schedule for the personal.• Assurance the reception, conservation, transport, conservation of blood process.• Signing the laboratory reports.• Supervising to deliver the laboratory studies on time to the patients.• Elaborating SOP´s, Biosecurity and quality Laboratory manuals

Ciudad De México Y Alrededores, México

• Evaluating the quality and integrity of study site practices related, provide monitoring visits and manage Investigator sites, as required by the study in adherence with GCP and ICH guidelines.• Verifying appropriate inform consent procedures and ensure subjects welfare and safety.• Dealing effectively with data queries by providing site staff with information and advice on query resolution.• Performing all in-house, on-site monitoring visit types. Initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.• Escalating quality issues to clinical team lead or manager.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment case report form completion and submissions and data query generation and resolutions, providing site staff with information.• Creating and maintain appropriated documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.• Responsible for training the investigators and site staff about the clinical study procedures.• Conducting site monitoring visits according the planned budget specified in the contract• CRA participated on the data lock for the study.• Reviewing the data collected in order to assure its integrity and validity.• Preparing and performing Investigator Payments.• Writing and correcting ICF for studies• Recollecting and update electronic TMF• Contact potential investigator to invite them to new trials.• Conduction of feasibilities.• Reviewed and verification SAEs and AEs.

Mexico City Area, Mexico

• Evaluating the quality and integrity of study site practices related, provide monitoring visits and manage Investigator sites, as required by the study in adherence with GCP and ICH guidelines.• Verifying appropriate inform consent procedures and ensure subjects welfare and safety.• Dealing effectively with data queries by providing site staff with information and advice on query resolution.• Performing all in-house, on-site monitoring visit types. Initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.• Escalating quality issues to clinical team lead or manager.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment case report form completion and submissions and data query generation and resolutions, providing site staff with information.• Creating and maintain appropriated documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.• Responsible for training the investigators and site staff about the clinical study procedures.• Conducting site monitoring visits according the planned budget specified in the contract• CRA participated on the data lock for the study.• Reviewing the data collected in order to assure its integrity and validity.• Preparing and performing Investigator Payments.• Writing and correcting ICF for studies• Recollecting and update electronic TMF• Contact potential investigator to invite them to new trials.• Conduction of feasibilities.• Reviewed and verification SAEs and AEs.

Mexico City Area, Mexico

• Evaluating the quality and integrity of study site practices related, provide monitoring visits and manage Investigator sites, as required by the study in adherence with GCP and ICH guidelines.• Verifying appropriate inform consent procedures and ensure subjects welfare and safety.• Dealing effectively with data queries by providing site staff with information and advice on query resolution.• Performing all in-house, remote monitoring visits and on-site monitoring visit types. Initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.• Escalating quality issues to clinical team lead or manager.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment case report form completion and submissions and data query generation and resolutions, providing site staff with information.• Creating and maintain appropriated documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.• Responsible for training the investigators and site staff about the clinical study procedures.• Conducting site monitoring visits according the planned budget specified in the contract• CRA participated on the data lock for the study.• Reviewing the data collected in order to assure its integrity and validity.• Preparing and performing Investigator Payments.• Recollecting and update electronic TMF• Contact potential investigator to invite them to new trials.• Conduction of feasibilities.• Reviewed and verification SAEs and AEs.

Mexico City Area, Mexico

• Evaluating the quality and integrity of study site practices related, provide monitoring visits and manage Investigator sites, as required by the study in adherence with GCP and ICH guidelines.• Verifying appropriate inform consent procedures and ensure subjects welfare and safety.• Dealing effectively with data queries by providing site staff with information and advice on query resolution.• Performing all in-house, remote monitoring visits and on-site monitoring visit types. Initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.• Escalating quality issues to clinical team lead or manager.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment case report form completion and submissions and data query generation and resolutions, providing site staff with information.• Creating and maintain appropriated documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.• Responsible for training the investigators and site staff about the clinical study procedures.• Conducting site monitoring visits according the planned budget specified in the contract• CRA participated on the data lock for the study.• Reviewing the data collected in order to assure its integrity and validity.• Recollecting and update electronic TMF• Reviewed and verification SAEs and AEs.

Mexico City Area, Mexico

• Preparing audits or inspections following and based on the Protocol´s, Manual´s, SOP´s and local regulations. • Performing all type of visit and audits: Feasibility visit, Site Initiation visit, on-site monitoring visit, in-house and remote monitoring visits and close-out visits in accordance with contracted scope of work and GCPs, SOPs and Ministry of Health.• Evaluating and verifying each process and procedure described on Protocols, Manuals and SOP´s, following the procedures assuring adherence as required by GCP and ICH guidelines and local regulations. • Assuring that each member of the site staff is conducting the study protocol according to her role. • Reviewing the job description of the team member and verifying that is training according to his role. • Managing the progress of assigned studies by tracking regulatory submissions and approvals, recruitment, and enrollment• Assuring the completion of case report form and data query resolutions; providing site staff support. • Creating and maintaining appropriated documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation. • Writing and correcting ICF, Protocols and SOP´s.• Verifying appropriate inform consent and procedures to ensure subjects welfare and safety and the process were following to the objectives. • Verifying that the equipment’s are calibrated in order to provide quality data. • Ensuring site facilities meet the requirements to perform the procedures. • Reviewing and verification SAEs (Serious Adverse Reports) and AEs (Adverse Reports). • Conducting a meeting with the staff, during audits to know the owner of the processes and assurance they are following as are described. • Preparing and performing Investigator Payments. • Recollecting and updating electronic Trial Master File and systems used on the process.

Mexico City Area, Mexico

• Conduct the bioequivalence study according to sponsor protocol.• Verifying appropriate inform consent procedures and ensure subjects welfare and safety.• Escalating quality issues to clinical team lead or manager.• Review Inclusion and exclusion criteria for the bioequivalence study.• Verified the correct administration of the Study drug • Reviewed and verification SAEs and AEs.• Correct and review the Bioequivalence Protocol• Source documents verification.• Verification regulatory documents.• Elaborating and Reviewed clinical report.• Verified the correct process of blood sample taken

Mexico City Area, Mexico

• Clinical protocol review. • Verification of source and regulatory documents. • Reviewing and elaboration of clinical report. • Reviewing follow and resolution of monitoring issues. • Implementing tools for control of patients and studies. • Screening Randomized and patient´s schedule visits. • Taking blood samples, Vital signs and ECG. • Dispensing, accountability and temperature control of study drug. • Completing electronic and paper CRF. • Protocols, amendments and regulatory letters to IRB.• Notification to IEC regarding deviations, SAEs, SUSARs, CIOMS.• Query Resolution. • Management of Investigator Site File.• Managing Investigator site as required by the study in adherence with GCP and ICH guidelines. • Reviewing data collected to assure the integrity and validity.

Área Metropolitana De Ciudad De México

• Control the manufacturing processes according GMPs. • Preparation of reports and filling of documents corresponding to the processes of manufacture. • Perform audits for production areas.