Clinical Team Lead

hace 1 semana

Buenos Aires, Argentina Avature A tiempo completo

Trial Preparation, Conduct and Closeout Select sites, conduct and deliver the trial according to the clinical trial protocol, within trial timelines, and in compliance with ICH‑GCP, procedures and all other relevant applicable regulations. Perform/supervise local adaptation of the required documents for submission according to the package provided by the trial team in compliance with ICH‑GCP, procedures and all other relevant applicable regulations. Ensure all regulatory requirements are satisfied prior to trial/site initiation. Update all required dashboards set‑up for trial oversight. Oversee recruitment and define strategic approach at local level. Set up, manage and review OPU trial budget to ensure appropriate level of financial oversight. Timely budget updates based on trial changes. Ensure appropriate trial‑specific training of team members in line with Trial Training Plan. In collaboration with Site Monitoring Lead and CRAs: conduct appropriate trial oversight by monitoring compliance of trial sites and BI team to GCP, local regulations, BI SOPs and adherence to trial protocol. Ensure adequate trial supply distribution to sites. Oversee continuous and timely data entry and cleaning, and on‑time Database Lock. Trial contact for CRAs, investigators and site staff. Conduct regular project meetings during the trial, prepare and distribute associated minutes. In collaboration with Trial Record Specialist and with supports from CRAs as appropriate, ensure collection of required documents, with timely, complete and compliant archiving of all relevant documents for the eTMF and CTR Appendices. Supervision of close‑out activities in compliance with ICH‑GCP, procedures and all other relevant applicable regulations. Qualifications At least 5 years of experience in Clinical Research working for a pharmaceutical company or CRO. Strong clinical trial project management experience or CRA lead with potential to develop. Regional LATAM experience is preferred. Previous CRA experience is desirable. Understanding of local/regional major regulations. University degree in Life Science. Experience in managing oncology trials is desirable. Fluent in English is a must. Equal Opportunity Employer Fortrea is proud to be an Equal Opportunity Employer. As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based on race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, etc. #J-18808-Ljbffr

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