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Parexel
Parexel
Sponsor pentru viza H1BAsistență medicalăConsultanțăLogistică
Parexel este o organizație globală de cercetare clinică ce deservește companii biofarmaceutice pe parcursul dezvoltării de medicamente noi. Activitatea sa acoperă studii clinice de fază I–IV, gestionarea portofoliilor și a studiilor, strategia de reglementare, accesul la piață și planificarea ciclului de viață. Cu peste 21.000 de profesioniști, Parexel îmbină expertiza clinică, de reglementare și terapeutică cu perspectivele pacienților și designuri inovatoare ale studiilor. Compania sprijină cercetarea în domenii precum oncologia, neuroștiințele și bolile rare, punând accent pe eficientizarea dezvoltării clinice și pe orientarea acesteia către pacienți.
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Senior Clinical Data Manager – FSP, Mexico Remote

Lead clinical data management for Parexel’s global Phase 1–4 studies from Mexico. Oversee EDC, eCRFs, databases, vendors, and regulatory data activities while supporting cross-functional study teams.

ARArgentinaMXMexicRemoteNormă întreagăSeniorLimbă Obligatorie: englezăCercetare clinică

Descriere

  • Lead large clinical studies or related study series with limited guidance
  • Represent Data Management on the CTWG for assigned studies
  • Coach and develop junior Data Management professionals
  • Oversee Data Management activities delivered by CROs and external vendors
  • Assess protocols to ensure suitable data capture and eCRF design
  • Evaluate eCRF data requirements
  • Partner with CRAs, programmers, study managers, and statisticians on eCRFs, annotated eCRFs, and CRF completion guidelines
  • Direct the creation of data edit-check specifications and data listings
  • Coordinate EDC system design and testing, and troubleshoot system issues
  • Create or lead the creation of Data Management Plans
  • Review clinical team materials and provide feedback on monitoring plans, statistical analysis plans, and vendor specifications
  • Deliver training on EDC systems and eCRF completion guidelines
  • Reconcile external header data and Serious Adverse Events with the clinical database
  • Lead database upgrades and migrations, including User Acceptance Testing
  • Keep study workbooks and Data Management records current
  • Execute database lock and freeze activities in line with SOPs
  • Take part in team meetings and help develop SOPs, work instructions, and process documentation
  • Support onboarding and training for new employees and contractors

Cerințe

  • At least 8 years of Data Management experience in the pharmaceutical or biotechnology industry, or equivalent work in an FDA-regulated environment, including experience leading studies
  • Proven project management ability with strong multitasking skills
  • Working knowledge of Phase 1–4 clinical studies, core Data Management activities, and vendor collaboration
  • Thorough knowledge of regulatory guidance and industry standards, including ICH and FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, and WHO Drug Dictionaries
  • Strong attention to detail and the ability to work independently, within multidisciplinary teams, and with external partners and vendors
  • Excellent written and spoken English communication skills
  • Oncology or CNS experience and knowledge of Phase III pivotal studies preferred
  • Willingness to travel for off-site meetings or training seminars as required
  • Strong computer and technical skills, including the ability to learn multiple applications; Data Management and Electronic Data Capture experience is desirable
  • BA/BS degree, preferably in a scientific or healthcare discipline

Beneficii

  • Full-time role
  • Work contributing to therapies that benefit patients
  • Access to training and mentoring
  • Work within a professional, multidisciplinary environment

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