- Assume leadership in handling tasks at trial sites- Maintain a good level of influence to achieve the clinical trial targets at the participating sites- Accountable of the delegated activities- Management of activities related to the monitoring activities within the office- Handling in a timely manner any activity related to the support of clinical trials department- Collect and report appropriately any Serious Adverse… Show more - Assume leadership in handling tasks at trial sites- Maintain a good level of influence to achieve the clinical trial targets at the participating sites- Accountable of the delegated activities- Management of activities related to the monitoring activities within the office- Handling in a timely manner any activity related to the support of clinical trials department- Collect and report appropriately any Serious Adverse Events to the pharmacovigilance area to be reported in a timely manner to the regulatory authority and global safety- Any other responsibility that can be required. Show less

- Recognize, exemplify and adhere to Company’s values which center around our commitment to people, clients and performance.- As a member of staff, embrace and contribute to culture of process improvement with a focus on streamlining process adding value to business and meeting client needs.- Expert knowledge of Company SOPs/WPs, ICH, GCP and appropriate Regulations.- Recruitment of Investigators- Act in a lead role on a study assuming additional responsibilities as… Show more - Recognize, exemplify and adhere to Company’s values which center around our commitment to people, clients and performance.- As a member of staff, embrace and contribute to culture of process improvement with a focus on streamlining process adding value to business and meeting client needs.- Expert knowledge of Company SOPs/WPs, ICH, GCP and appropriate Regulations.- Recruitment of Investigators- Act in a lead role on a study assuming additional responsibilities as detailed/documented by the Project.- Participate in data listings reviews as applicable.- Responsible for cost effectiveness.- Participate in training and mentoring new staff up to CRA level as appropriate.- Assist with marketing the company if when appropriate - Independent and proactive coordination of all the necessary activities required to set up and monitor a study, including but not limited to the following:• Identify Investigators• Preparation of regulatory submissions.• Design of patient information sheets and Consent Forms.• Ensure timely submission of protocol/consent documents for Ethics/IRB approval.• Pre study/placement and initiation visits.• Conduct regular monitoring visits in accordance with the Company site monitoring/Sponsor site monitoring SOP as appropriate.• Maintain all files and documentation pertaining to studies.• Motivate investigators in order to achieve recruitment targets.• Complete accurate study status reports.• Ensure the correct storage of drugs (IP) and the diligent account of all IP in accordance with SOPs.• Participate in the preparation of and review of study documentation.• Participate in feasibility studies for new proposals as required.• Ensure correct archiving of files on completion of a study.• Assume additional responsibilities as directed by the project. Show less

Adhere with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely manner.Knowledge of applicable SOPs, guidelines and study procedures.Assist with protocol and CRF review.Develop informed consent forms.Conduct study feasibility and site selection activities.Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities.Assist with investigator meeting… Show more Adhere with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely manner.Knowledge of applicable SOPs, guidelines and study procedures.Assist with protocol and CRF review.Develop informed consent forms.Conduct study feasibility and site selection activities.Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities.Assist with investigator meeting activities including organization, preparation and attendance.Conduct site management activities, including but not limited to site qualification visits, site initiation visits, site training, site interim monitoring visits, and site close out Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines.Write study visit reports and follow up letters within the timeline established by applicable SOPs and guidelines.Coordinate timely shipment of clinical supplies and study drug to sites.Ensure proper storage, dispensation and accountability of clinical supplies and study drug.Maintain adequate site tracking records.Follow up of drug safety issues and safety reports in timely manner, if applicable.Communicate site study issues, concerns, and progress Project Manager, Clinical Team Lead and Clinical Research Manager accordingly.Development and implementation of corrective actions when appropriate.Input and maintain study information concerning subject status of financial reimbursement to sites.Conduct and assist with administrative activities as a member of the project.Review study visit reports, follow-up letters and site communication generated by other CRAs for timeliness, quality, consistency, and appropriate documentation and resolution of issues, with support from Clinical Team Lead or Clinical Research Manager as needed. Show less

- Clinical trial start-up activities by understanding the client objectives and assist in the development of the plan for country and site distribution. - Responsible of Start-up delivery plan, Study Budget review and Contract set-up according to the Sponsor contract.- Vendor management and set-up.- Regulatory strategy development and presentation during Kick-off Meeting with the client.- Analyze costs, personnel hours and project needs during the start-up… Show more - Clinical trial start-up activities by understanding the client objectives and assist in the development of the plan for country and site distribution. - Responsible of Start-up delivery plan, Study Budget review and Contract set-up according to the Sponsor contract.- Vendor management and set-up.- Regulatory strategy development and presentation during Kick-off Meeting with the client.- Analyze costs, personnel hours and project needs during the start-up phase.- Responsible for Regulatory process to achieve Country Site Activation.- Improve feasibilities in Mexico by regulatory perspective (Ethics & Research Ethics committees compliance)- Strategic management of high workload of Investigator and Ancillary Contracts.- Proactive Contract negotiation with Public Health Institutes successfully by understanding the complexity of the process and by building a fluent communication channel with Legal Areas.- Mentoring of two trainees in charge of Local initiatives as ECs compliance and Contract Management Improvements. Evaluation of work performance of both trainees.- Start-up processes improvement through an appropriate analysis of workflows by MS-Project by fast-tracking or crashing projects to reduce time with a high quality (focused in Contracts).- Effective support in import process and follow-up of a successful strategy to meet the new import requirements. Participation in hiring process.- Therapeutic Areas:, Dyslipidemia, Diabetes, Rheumatology: Rheumatoid Arthritis/Psoriatic ArthritisMental Disorders: Major Depressive Disorder Show less

Project Leader of "Inspection Readiness” of LATAM.Support the Project Team in the preparation, management and monitoring and control of data submissions to Ethics Committees and MoH.Coordinate and review and approval process of Contracts of Clinical Research Unit.Coordinate and review documents translation.Support sites and Internal Clinical team with Trial supplies and Investigational Product to the study sites.Support the Clinical Team in monitoring activities.

Planning, implementation, conduct and execution of clinical trials.Ensure that all activities of the clinical studies are being conducted in accordance with GCP / ICH, SOP's local and international requirements.

Submission and follow up of regulatory package IRB/EC and HA.

Support the Medical Direction team with bibliographic information and administrative support.