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BeOne Medicines
BeOne Medicines
BiotechnologyHealthcarePharmaceuticals
BeOne Medicines is a Switzerland-domiciled global oncology company focused on discovering and developing innovative cancer treatments designed to improve affordability and access. Its portfolio covers hematologic cancers and solid tumors, supported by an expanding pipeline of novel therapeutics advanced through in-house capabilities and external collaborations. With more than 11,000 colleagues across six continents, BeOne Medicines is working to broaden access to medicines for patients worldwide.
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Regional Clinical Trial Management Associate

Support regional clinical study delivery, trial documentation, study systems, and budgets at BeOne Medicines. The company develops cancer medicines and therapies.

USUnited States
$72,800 – $97,800 / year
RemoteFull-timeJuniorMiddleNo degree requiredEnglish RequiredClinical Trial AssociateGeneral

Description

  • Assist the Regional Clinical Study Manager with regional study delivery and delegated study activities.
  • Help Clinical Research Associates and Study Start-up Specialists deliver studies within their countries.
  • Support trial feasibility, start-up, document preparation and review, sample tracking, and participant enrollment.
  • Update CTMS records; prepare ISF binders; collect and customize documents, including ICFs; and maintain the eTMF.
  • Apply relevant regulations and ICH guidelines.
  • Coordinate regional and country team meetings, including agendas and minutes.
  • Maintain SharePoint folders, distribution lists, eTMF, CTMS, and other study systems.
  • Help manage system access requests and user accounts.
  • Assist with study start-up and investigator meetings, and with TMF creation, review, and quality checks.
  • Help address regional or country clinical supply issues and support data cleaning.
  • Draft site newsletters and clinical trial correspondence.
  • Maintain public registry information and contribute to Clinical Study Reports.
  • Assist with operational risk identification, audits, inspections, tools, work instructions, and SOPs.
  • Help set up vendors and manage regional study budgets, purchase orders, payment follow-up, and accruals.

Requirements

  • At least one year of clinical research experience in biotechnology, pharmaceuticals, or a CRO.
  • Knowledge of clinical operations methods and the operational aspects of clinical study processes.
  • Experience with MS Office, eTMF, and CTMS.
  • A bachelor’s degree, preferably in a scientific or healthcare field, is preferred.
  • Some travel may be required.
  • Exceptions may be considered for candidates with relevant clinical operations experience.

Benefits

  • Eligible for an annual bonus plan in non-commercial roles.
  • Eligible for incentive compensation in commercial roles.
  • Discretionary equity awards.
  • Optional participation in the Employee Stock Purchase Plan.
  • Medical insurance.
  • Dental insurance.
  • Vision coverage.
  • 401(k) plan.
  • FSA/HSA accounts.
  • Life insurance.
  • Paid time off.
  • Wellness benefits.

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