Senior Clinical Scientist - FSP (Edmonton)

Senior Clinical Scientist - FSP (Edmonton)

23 Oct
|
Parexel
|
Edmonton

23 Oct

Parexel

Edmonton

Job Overview The Senior Clinical Scientist (SCS) may lead or support a study or studies, depending on size/complexity. The SCS as lead is accountable for the clinical/scientific execution of the protocol. If lead, accountable for the clinical/scientific execution of the protocol.

As lead, will be responsible as the Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites) Scientific lead on Clinical Trial Team (CTT) Medical Monitoring Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports 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 Participates in Database lock activities Protocols/amendments – collaborates with medical writer, participates in governance committee review Provides scientific input to SM for data management activities (e.g., Coordinates planning of lab, bio specimens and imaging specifications Collaboratively plans CSRs,



CTDs/WMAs with medical writing Collaborates with medical writing to develop trial results communication for investigators Provides scientific assessment for Operational Reviews May act as mentor to other CSs Complies with required training curriculum 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. Proficiency in Microsoft Office (Outlook, Word, Excel and PowerPoint) required. Motivate their team, handle and delegate responsibilities, listen to feedback and remain versatile .

Minimum 7 years with BS/BA or 5 years with 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 / biotech / CRO company experience required (leads, monitors and supervises the tasks related to clinical trials) in the last 5 years. Minimum 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 Degree in Life Sciences Bachelor of Science/Bachelor of Arts/Master of Science/PhD #

📌 Senior Clinical Scientist - FSP (Edmonton)
🏢 Parexel
📍 Edmonton

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