About this role
This role supports Clinical Pharmacology Scientific Support & Reporting by preparing scientific reports and presentations for clinical trials. The associate helps construct Phase 1 study planning documents, writes Phase 1 protocols, performs literature and competitive intelligence searches, and assists with pharmacokinetic data analysis under supervision.
Key Responsibilities
- Prepare scientific reports and presentations for clinical trials
- Develop Phase 1 study planning documents and write Phase 1 protocols
- Comply with IQS documents and Study protocols
- Perform literature and competitive intelligence searches
- Assist with clinical study data analysis and blinded/un-blinded pharmacokinetic analysis
Technical Overview
You will produce Phase 1 clinical documentation (planning documents and protocols) while ensuring compliance with IQS documents and Study protocols. You will analyze clinical study data using available software and assist with ongoing blinded/un-blinded pharmacokinetic analysis, then generate reports and presentations from the results.
Ideal Candidate
The ideal candidate is an entry-level or early career associate with a Bachelor’s degree in a science-related field (or a Master’s in pharmacology) and 2+ years of pharmaceutical industry experience. They can draft Phase 1 protocols and study planning documents, perform literature and competitive intelligence searches, and support pharmacokinetic (blinded/un-blinded) analysis with strong written and oral communication.
Must-Have Skills
Prepare scientific reports and presentations related to clinical trialsconstruct phase 1 clinical study planning documentswrite Phase 1 protocolsComply with procedures set forth in relevant IQS documentsComply with Study protocolsperform literature and competitive intelligence searchesanalyze clinical study data using available softwareblinded/un-blinded pharmacokinetic analysisgood oral and written communication skillsability to use computer to generate reportsanalyze dataand create presentations
Nice-to-Have Skills
participate in process improvement initiatives
Tools & Platforms
available softwaretemplates
Required Skills
Prepare scientific reports and presentationsconstruct phase 1 clinical study planning documentswrite Phase 1 protocolscomply with IQS documentscomply with Study protocolsliterature searchescompetitive intelligence searchesanalyze clinical study datapharmacokinetic analysisblinded/un-blinded pharmacokinetic analysiscomputer generate reportsanalyze datacreate presentations
Hard Skills
scientific reportspresentationsclinical trialsPhase 1 protocolsphase 1 clinical study planning documentsliterature searchescompetitive intelligence searchesclinical study data analysispharmacokinetic analysisblinded/un-blinded pharmacokinetic analysisIQS documentsreport generation (computer-generated reports)data analysis (using available software)assisting with planning documentscomputer proficiency to generate reportsanalyze dataand create presentationsGxP study protocol compliance (implied by Study protocols and IQS compliance wording)
Soft Skills
pay close attention to detailproducing work of the highest qualitygood oral and written communication skillsability to receive and complete assignments and tasks with supervisionprocess improvement participation
Keywords for Your Resume
Associate IClinical PharmacologyScientific SupportReportingclinical trialsscientific reportspresentationsPhase 1 protocolsphase 1 clinical study planning documentsIQS documentsStudy protocolsliterature searchescompetitive intelligence searchespharmacokinetic analysisblinded/un-blinded pharmacokinetic analysisclinical study datacomputer generate reportsdata analysiscreate presentationsoral and written communication skillsBachelor's degree in ScienceMasters degree in pharmacologyAssociate degreeRNclinical study data analysis
Deal Breakers
Must have Bachelor’s degree (science-related) with +2 years pharmaceutical industry experience or Masters degree in pharmacology or related field, Must demonstrate ability to prepare scientific reports/presentations and conduct pharmacokinetic analysis (blinded/un-blinded)
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