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Biogen
Biogen
5.001 – 10.000 Angajați
Sponsor pentru viza H1BAsistență medicalăBiotehnologieIndustria prelucrătoare
Biogen este o companie de biotehnologie și servicii medicale axată pe cercetarea, dezvoltarea și furnizarea de tratamente pentru afecțiuni neurologice grave. Activitatea sa vizează boli precum Alzheimer, scleroza multiplă și atrofia musculară spinală, combinând cercetarea clinică, colaborarea științifică și dezvoltarea de medicamente pentru a contribui la progresul neurologiei. Compania pune, de asemenea, accent pe îmbunătățirea accesului la îngrijire și pe promovarea unei mai mari echități în domeniul sănătății.
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Senior Clinical Data Manager — Biogen, United States Remote

Lead clinical data management activities for Biogen trials, including data review, cleaning, reconciliation, and risk oversight. Partner with study teams and vendors to maintain data quality, apply standards, and support timely study delivery.

USStatele Unite ale Americii
93.000 $ – 120.750 $ / an
RemoteNormă întreagăSeniorLimbă Obligatorie: englezăCercetare clinică

Descriere

  • Serve as an operational Clinical Data Management subject matter expert for assigned clinical trials
  • Support the full study lifecycle while sharing accountability with the Clinical Data Lead
  • Design and validate CRFs, edit checks, reports, and listings
  • Prepare study documents, clean data, manage queries, and identify and reduce operational risks
  • Provide backup support to the Clinical Data Lead and collaborate with cross-functional teams
  • Implement data strategy and verify the application of global standards
  • Help track and report overall study progress
  • Conduct comprehensive study data reviews in line with Biogen procedures, regulatory guidance, and study-specific plans
  • Reconcile EDC data with safety databases and external vendor systems
  • Analyze data issues and propose appropriate resolutions
  • Evaluate study metrics, communicate data matters across internal and external groups, and escalate issues promptly
  • Help develop, improve, and innovate Data Management processes
  • Contribute to evaluations of vendor quality and operational efficiency
  • Take part in cross-functional initiatives, study-level work, and special projects

Cerințe

  • A bachelor’s degree in a scientific field such as statistics, mathematics, economics, computer science, information technology, biology, or social science is strongly preferred
  • At least four years of Clinical Data Management experience is required
  • Strong technical proficiency with Electronic Data Capture platforms, preferably Medidata Rave
  • Experience with data review tools, preferably Elluminate
  • Project management ability to work effectively across business functions
  • Excellent written and spoken English communication skills
  • Ability to communicate effectively with diverse cross-functional teams and in varied situations
  • Meticulous attention to detail and a demonstrated ability to manage competing priorities
  • Working knowledge of drug development and the biopharmaceutical industry
  • Recognized Clinical Data Management subject matter expertise among peers

Beneficii

  • Short- and long-term incentive opportunities, including cash bonuses and equity awards
  • Medical, dental, vision, and life insurance coverage
  • Fitness and wellness offerings, including fitness reimbursement
  • Short- and long-term disability insurance
  • At least 15 days of paid vacation
  • Additional year-end closure leave from December 26 through December 31
  • Up to 12 company-paid holidays
  • Three paid days off for personal significance
  • 80 hours of sick leave per calendar year
  • Paid maternity and parental leave
  • 401(k) participation with company matching contributions
  • Employee stock purchase plan
  • Tuition reimbursement of up to $10,000 per calendar year
  • Access to Employee Resource Groups
  • Learning, development, and skill-expansion opportunities

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