Brazil - Senior Clinical Scientist Consultant

1 week ago Be among the first 25 applicants Responsibilities May lead or support a study or studies, depending on size/complexity. If lead, accountable for the clinical/scientific execution of the protocol. As lead, will be responsible for the following: Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites) Responsible for trial design and endpoint development in collaboration with CD Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports Sets up/supports SAC, DMC, adjudication committees Protocols/amendments – collaborates with medical writer, participates in governance committee review Authors protocol clarification letters Contributor to study specific documents (e.g., SMP) Reviews/updates informed consent Provides scientific input to SM for data management activities (e.g., EDC, DRP, CRFs) Monitors data issues requiring clinical input Monitors central lab reports and other external data for safety and critical values Prepares scientific slides, attends and presents protocol information at Investigator Meeting Scientific lead on Clinical Trial Team (CTT) Reviews specs, initiates allocation (randomization) request form and approval schedule in allocation schedule generation system Coordinates planning of lab, bio specimens and imaging specifications Co- authors newsletters with SM Participates in Database lock activities Collaboratively plans CSRs, CTDs/WMAs with medical writing Supports publications/presentations as needed Reconciles and review all protocol deviation classifications in SPECTRUM Assesses and prepares protocol deviation list for CSR Collaborates with medical writing to develop trial results communication for investigators Provides scientific assessment for Operational Reviews Supports SM/MW activities as needed to achieve CTT deliverables. Provides clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO) May act as mentor to other CSs Position Senior Clinical Scientist I (Clinical Research/Clin Ops) Description of Services May lead or support a study or studies, depending on size/complexity. If lead, accountable for the clinical/scientific execution of the protocol. As lead, will be responsible for the following: Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites) Responsible for trial design and endpoint development in collaboration with CD Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports Sets up/supports SAC, DMC, adjudication committees Protocols/amendments – collaborates with medical writer, participates in governance committee review Authors protocol clarification letters Contributor to study specific documents (e.g., SMP) Reviews/updates informed consent Provides scientific input to SM for data management activities (e.g., EDC, DRP, CRFs) Monitors data issues requiring clinical input Monitors central lab reports and other external data for safety and critical values Prepares scientific slides, attends and presents protocol information at Investigator Meeting Scientific lead on Clinical Trial Team (CTT) Reviews specs, initiates allocation (randomization) request form and approval schedule in allocation schedule generation system Coordinates planning of lab, bio specimens and imaging specifications Co- authors newsletters with SM Participates in Database lock activities Collaboratively plans CSRs, CTDs/WMAs with medical writing Supports publications/presentations as needed Reconciles and review all protocol deviation classifications in SPECTRUM Assesses and prepares protocol deviation list for CSR Collaborates with medical writing to develop trial results communication for investigators Provides scientific assessment for Operational Reviews Supports SM/MW activities as needed to achieve CTT deliverables. Provides clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO) May act as mentor to other CSs Minimum Years of Experience Minimum 7 years for BS/BA or 5 years for MS/PhD pharmaceutical and/or clinical drug development (such as pharmaceutical/biopharma companies, hospital settings, research sites, clinical trial units, CRO, SMO) in the last 10 years required experience Minimum 2 years as a lead CS (phase I-IV clinical trials) with pharmaceutical/bio-tech/CRO company experience required (leads, monitors and supervises the tasks related to clinical trials) in the last 5 years. TA-specific experience required for Oncology.TA specific experience preferred for IDV and GSM Indication specific experience preferred Experience reviewing and resolving study related data issues such as; issued queries, resolved queries, accurate review of medical records, identify any errors in data by performing data review that require further clarification with the study sites, etc. required 2 years medical monitoring (proficient in reviewing patient data and resolving discrepancies in the following areas such as adverse events, trends of adverse events, end point management, labs) experience required Demonstrated oral and written communication skills Proficiency in Microsoft Office (Outlook, Word, Excel and PowerPoint) required. One Note experience preferred. Motivate their team, handle and delegate responsibilities, listen to feedback and remain flexible. Educational Requirements Degree in Life Sciences BS/BA/MS/PhD Seniority level Mid-Senior level Employment type Full-time Job function Research, Analyst, and Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at ClinChoice by 2x We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr