Sr. Clinical Scientist - Upper Gwynedd Township
1 day ago
Job summary
Sr. Clinical Scientist I 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 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 critical values Prepares scientific slides attends presents protocol information at Investigator Meeting Scientific lead on Clinical Trial Team CTT Reviews specs initiates allocation request form approval schedule in allocation schedule generation system Coordinates planning of lab bio specimens imaging specifications Co-authors newsletters with SM Participates in Database lock activities Collaboratively plans CSRs CTDsWMAs with medical writing Supports publications/presentations as needed Reconciles reviews all protocol deviation classifications in SPECTRUM Assesses prepares protocol deviation list for CSR Collaborates with medical writing to develop trial results communication investigators Provides scientific assessment Operational Reviews Supports SMMW activities as needed achieve CTT deliverables Provides clinical specifications SM support interactions external vendors e.g IVRS epRO May act mentor other CSs Minimum FTE Years Of Experience Minimum 2 years pharmaceutical drug development experience as a lead CS required Medical monitoring experience required TA-specific experience beneficial Excellent Excel PP skills required Excellent written oral communication skills Educational Requirements Degree Life Sciences BSBA MSPhD 2+yrs relevant career experience Degree Life Sciences significant experience clinical development >11years BSAW ith 7+yrs clinical research experience MSpHD 5+ yrs clinical research experiencelength="30-50 words"/>
Job description
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