Site Contract Specialist I/Ii

Site Contract Specialist I/Ii
Empresa:

Allucent


Detalles de la oferta

.At AllucentTM, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Site Contract Specialist I/II (SCS) to join our A-team (hybrid*/remote)! The Site Contract Specialist coordinates and performs site contract and budget negotiations at country level, working with the Global Site Contract Manager (GSCM) as well as Global Start-Up Manager or Local Start-Up Lead (LSUL) as applicable. This position supports the site contract and budget negotiation process from template review, preparation of site-level contracts through execution, provides expertise on country requirements and specificities in terms of contract and budget negotiation process.In this role your key tasks will include:Assist in review of country-level contract template in the process of templates' development and approval with Sponsor at the start of the clinical study; Prepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical study according to the approved negotiation parameters; Support communication with sites and internal personnel regarding the status of contracts and contract related documentsIdentify and assesses legal, financial, and operational risks and escalate to appropriate Global Site Contract Manager (GSCM); Provide recommendations and alternative resolutions throughout negotiations using established escalation channels; Assist in arranging translation of the final country CTA template and/or negotiated contracts, where applicableProvide the final/draft CTA and site budget for submission, where requiredObtain site signature as well as Sponsor/Allucent signature, as applicableTrack relevant information and data in CTMS and/or other tracking tools, ensure planned dates are up to date and reliable for study team's planning of site activationKeep up to date with applicable local regulations impacting clinical trial contracts.RequirementsTo be successful you will possess:- Law degree or Paralegal certification preferred or equivalent combination of education, training, and experienceMinimum 2 years' experience in contract negotiations in clinical research or drug development areaA basic understanding of the drug development process


Fuente: Jobtome_Ppc

Requisitos

Site Contract Specialist I/Ii
Empresa:

Allucent


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