Director, Data Management

3 weeks ago

New York NY, United States Planet Pharma Full time

Planet Pharma
https://cdn.haleymarketing.com/templates/63514/logos/square.png
https://www.propharmagroup.com
https://www.propharmagroup.com
true

345 Park Ave South
New York,
NY10010

US


Job DescriptionPlanet Pharma's client, a NYC-based early-stage biopharmaceutical company in with an innovative portfolio of novel, widely applicable therapeutic drug candidates, is seeking a high-performing, motivated, experienced Director of Data Management to provide clinical data management support for all sponsored trials.  The Director will be capable both of overseeing data management responsibilities that have been transferred to CROs and of selecting Data Management platforms, building EDC systems, designing and implementing edit checks, and ensuring all processes are performed according to SOPs for internally held trials.  The successful candidate will also be skilled in data review and presentation with the ability to code/program and will represent DM both internally and externally. Our office is located on Manhattan’s west side.  This is an in-person position.Responsibilities:Oversee all day-to-day data management activities, timelines and deliverables for clinical trialsProvide technical and business expertise in support of data management deliverablesWork in accordance with Regulatory guidance, GCP, corporate SOPs, and Work Instructions.Ensure timeliness and quality of data deliverables Select EDC platform(s) and build EDC systems for in-house clinical trialsGenerate edit checksMonitor data, generate requested reportsPresent data as requested to support clinical review, meetings, and presentationsGenerate Data Management Plans, eCRF completion guidelinesPerform UAT testing for external projects; plan UAT testing for internal projectsCommunicate clearly with internal and external collaborators, represent DMQUALIFICATIONS:The successful candidate will be an innovative and collaborative individual with a strong track record of hands-on clinical data management experience.  BS in a clinical or scientific discipline.Desire to join a biotech company in its start-up phase; to contribute to enterprise growth2 – 5 years direct clinical data management experience in a pharmaceutical or CRO environment.Demonstrated knowledge of problem solving (e.g., queries, edit checks, specifications, etc.) with strong analytical skills to ensure the generation of high-quality, reliable, and statistically sound data from clinical trials.Extensive knowledge of EDC tools/platforms coupled with a strong understanding of datasets/programming tools, e.g., ADAM, SDTM, SAS, R, etc.Experience across multiple phases of clinical development Strong organizational skills Strong communications skillsCreative and resourceful; a self-starter, proactive with high performance standards, likes to get things done.?

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