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Oruka Therapeutics
Oruka Therapeutics
11 – 50 Xodimlar
BiotexnologiyaFarmatsevtika mahsulotlariSog‘liqni saqlash
Oruka Therapeutics surunkali teri kasalliklari uchun biologik dori vositalarini ishlab chiquvchi, blyashkali psoriaz va u bilan bog‘liq yallig‘lanish holatlariga e’tibor qaratadigan biofarmatsevtika kompaniyasidir. Tajribali biofarmatsevtika mutaxassislaridan iborat jamoa kasallikni yanada to‘liq nazorat qilishga ko‘maklashish va dozalash chastotasini kamaytirishga mo‘ljallangan monoklonal antitana terapiyalarini ishlab chiqmoqda. Kompaniya faoliyati dermatologiya va yallig‘lanish kasalliklarini davolashda davolash natijalari hamda bemor tajribasini yaxshilashga qaratilgan.
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Kompaniyadagi ish o‘rinlari

Clinical Data Management Manager - Oruka Therapeutics (Hybrid)

Lead clinical data management for Phase I-IV studies at Oruka Therapeutics, a biotechnology company developing biologics for chronic skin diseases. Oversee CROs, clinical databases, data quality, vendor reconciliation, and regulatory readiness.

USAmerika Qo‘shma ShtatlariMAMassachusets
146 000 $ – 161 000 $ / yil
GibridTo‘liq stavkaSeniorYetakchiTalab Qilinadigan Til: inglizchaKlinik tadqiqot
Google Cloud PlatformOracle

Tavsif

  • Direct clinical data management activities for assigned Phase I-IV clinical studies
  • Act as lead Clinical Data Manager for approximately three to four studies from start-up through conduct, database lock, and closeout
  • Manage CRO and vendor activities, schedules, deliverables, budgets, and contractual commitments
  • Oversee the design, development, testing, and validation of clinical databases, eCRFs, edit checks, data validation specifications, and UAT
  • Review and approve Data Management Plans, CRFs, completion and review guidelines, edit check specifications, and related documents
  • Direct data cleaning and reconciliation for laboratory, ECG, imaging, eCOA/ePRO, and other vendor data
  • Safeguard data quality during interim analyses, database freezes, unlocks, and final database lock
  • Maintain data review logs and coordinate resolution of queries and data issues with CROs
  • Collaborate with Biometrics, Statistical Programming, and Biostatistics on listings, reports, patient profiles, and programming checks
  • Ensure adherence to regulatory requirements, ICH-GCP guidelines, and company SOPs
  • Maintain Data Management TMF/eTMF records and support audits and regulatory inspections
  • Develop and report data management performance metrics while driving process improvements
  • Lead or contribute to study kick-off, investigator, vendor, and cross-functional meetings
  • Build effective partnerships with Clinical Operations, Medical, Safety, Regulatory Affairs, Quality Assurance, Biostatistics, Statistical Programming, and external partners
  • Report to the Senior Director of Data Management

Talablar

  • Bachelor's degree in Life Sciences, Computer Science, Information Technology, or a related scientific discipline
  • At least 10 years of clinical research experience, including 5 or more years in direct Clinical Data Management within a sponsor, CRO, biotechnology, or pharmaceutical organization
  • Track record of leading Data Management activities across Phase I-IV clinical trials
  • Experience overseeing CROs and external vendors
  • Proficiency with Electronic Data Capture systems such as Medidata Rave, Oracle Clinical, Medrio, Veeva CDMS, or comparable platforms
  • Experience working with electronic Trial Master Files (eTMF)
  • Thorough knowledge of GCP, ICH Guidelines, FDA, EMA, PMDA, and other applicable global regulatory requirements
  • Experience reviewing clinical databases, edit checks, CRFs, Data Management Plans, and database validation documentation
  • Strong organizational, analytical, project management, and problem-solving capabilities
  • Clear written and verbal communication skills, with the ability to work effectively across multidisciplinary teams
  • Ability to manage multiple clinical studies and competing priorities independently in a fast-paced setting

Imtiyozlar

  • Competitive salary and benefits package
  • Equity participation
  • Opportunity for a performance-related bonus
  • Supportive and inclusive team environment
  • Professional growth and development opportunities
  • Energetic startup culture
  • Chance to contribute directly to bringing new medicines to patients

O‘xshash ish o‘rinlari

Eurofins

Remote Payroll Specialist — Pennsylvania

Eurofins
H1B vizasi homiysiLogistikaOziq-ovqat va ichimliklarSog‘liqni saqlash
USAmerika Qo‘shma ShtatlariPAPensilvaniya
21 $ – 23 $ / soat
MasofaviyTo‘liq stavkaO‘rta darajaSeniorTalab Qilinadigan Til: inglizchaIsh haqi hisoblash
BulutOracle

Process weekly and biweekly US payroll for Eurofins Scientific, an international life sciences testing company. Handle garnishments, reconciliations, Oracle HCM Cloud, ADP, and year-end reporting.

Ochish