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BeOne Medicines
BeOne Medicines
BiotehnoloģijaFarmaceitiskie produktiVeselības aprūpe
BeOne Medicines ir Šveicē reģistrēts globāls onkoloģijas uzņēmums, kas pievēršas inovatīvu vēža ārstēšanas līdzekļu atklāšanai un izstrādei, lai uzlabotu to pieejamību un cenas pieņemamību. Uzņēmuma produktu portfelis aptver hematoloģiskos vēža veidus un solidārus audzējus, un to papildina augošs jaunu terapiju izstrādes plāns, kas tiek īstenots, izmantojot iekšējās kompetences un ārēju sadarbību. Ar vairāk nekā 11 000 darbinieku sešos kontinentos BeOne Medicines strādā, lai pacientiem visā pasaulē uzlabotu zāļu pieejamību.
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Vakances uzņēmumā

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.

USAmerikas Savienotās Valstis
72 800 $ – 97 800 $ / gads
AttālinātiPilna slodzeJaunākais speciālistsVidējais līmenisGrāds nav nepieciešamsNepieciešamā Valoda: angļuKlīnisko pētījumu asistentsVispārīgi

Apraksts

  • 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.

Prasības

  • 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.

Priekšrocības

  • 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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