Senior Clinical Scientist

Job Title: Senior Clinical Scientist (SCS)

Position Purpose:

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.

Organizational Relationships: Reports to ExecuPharm (EP) assigned Line Manager with day-to-day direction from ClientLiaises with cross-functional lines as appropriate

Primary Duties: Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., Institutional Review Board (IRB), sites)Responsible for trial design and endpoint development in collaboration with Clinical Director (CD)Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE (Serious Adverse Event) reportsSets up/supports SAC (Scientific Advisory Committee), DMC (Data Monitoring Committee), adjudication committeesProtocols/amendments – collaborates with medical writer, participates in governance committee reviewAuthors protocol clarification lettersContributor to study specific documents [e.g., Study Monitoring Plan (SMP)]Reviews/updates informed consentProvides scientific input to Study Manager (SM) for data management activities (e.g., Electronic Data Capture, Data Review Plan, Case Report Forms)Monitors data issues requiring clinical inputMonitors central lab reports and other external data for safety and critical valuesPrepares scientific slides, attends and presents protocol information at Investigator MeetingScientific lead on Clinical Trial Team (CTT)Reviews specs, initiates allocation (randomization) request form and approval schedule in allocation schedule generation systemCoordinates planning of lab, bio specimens and imaging specificationsCo- authors newsletters with SMParticipates in Database lock activitiesCollaboratively plans CSRs (Clinical Study Reports), CTDs (Common Technical Documents)/WMAs (Worldwide Marketing Authorization) with medical writing Supports publications/presentations as neededReconciles and review all protocol deviation classifications in SMARTAssesses and prepares protocol deviation list for CSRCollaborates with medical writing to develop trial results communication for investigatorsProvides scientific assessment for Operational ReviewsSupports Study Management/Medical Writing activities as needed to achieve CTT deliverablesProvides clinical specifications to SM to support interactions with external vendors [e.g.,

Interactive Voice Response System (IVRS), electronic Patient Reported Outcome (ePRO)] May act as mentor to other Clinical Scientists (CSs)Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related trainingAdhere to EP and Client SOPs and processes

Skills and Education: BS/BA in Life Sciences with 7+ years clinical research experienceMS/PhD in Life Sciences with 5+ years clinical research experienceIf no degree in Life Sciences, must have significant experience in clinical development (>11 years)Minimum 2 years pharmaceutical experience with demonstrated leadership responsibilities required.Medical monitoring experience requiredExcellent Excel and PowerPoint (PP) skills requiredExcellent written and oral communication skillsTherapeutic Area (TA) specific experience beneficial

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