Brazil - Senior Clinical Scientist Consultant

1 dia atrás

Brasília, Distrito Federal, Brasil ClinChoice Tempo inteiro R$120.000 - R$250.000 por ano

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

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