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For your reference, we have included the original job posting below.
Sr Contracts Manager, Drug Dev Outsrc (Syntonix)
Job Number:
24258799
Company Name:
Biogen Idec
Job Location:
Waltham, MA US
Job Category:
Healthcare & Medical
Sr Contracts Manager, Drug Dev Outsrc (Syntonix)
Job Title Sr Contracts Manager, Drug Dev Outsrc (Syntonix) Location US-MA-Waltham Job Category Research & Preclinical Development Requisition Number 12601BR Job Description A Contracts Manager is required to support the Hemophilia clinical operations team and the rFVIIIFc and rFIXFc clinical programmes for Phase I to Phase III studies. The successful hire will be wholly dedicated to the Hemophilia group within the UK and Waltham offices but will have line management from, and will sit within, the DDO group in the UK office. Key responsibilities: ? Independently execute contract negotiation and management for site agreements. ? Create and negotiate complex investigator budgets. ? Management of CRO site contracting. ? Participate in upfront study strategy support. ? Execute consulting agreements & IST agreements. Lead cross functional or broad CBO initiatives. ? Draft departmental SOPs, Mentor/supervise Contracts Associate/ Contract Manager I/ Contractors. ? Able to train new hires on departmental processes. subject matter expert for contract templates/negotiations ? Manage a heavy workload - up to three significant studies in start up at the same time, effectively manage and prioritize their time with a minimal level of oversight. ? Plan, initiate and execute all CTA's (legal/budget/financial terms) with clinical trial sites for the clinical operations organization to achieve study specifications, timelines, and budgets. ? Evaluate changes in assigned clinical development program/projects to determine the impact on contractual agreements and developing and negotiating contract amendments if appropriate. ? Track contracts status and site budget until all site contracts are executed. ? Develop the site budget at a country level using the approved budgeting tool and historical data, and obtain approval on final country budget(s). ? Ensure site payments are made in accordance with the terms in the site agreement(s). ? Negotiate CDA language as requested; either requested by CRO or Clinical Operations personnel. ? If the CTA negotiations will be outsourced; manage the CRO to ensure contracts are executed in line with BIIB guidance and payments made in accordance with the terms in the site agreement(s). Responsible for arranging the site contracts kick-off meeting to ensure CRO is trained appropriately, and for ongoing management of CRO. Qualifications BS/BA; Masters preferred Preferred in Business or Health Care related field 4-6 years related experience or other relevant experience; equivalent combination of education and experience considered Education Detailed understanding of contract templates, commercial language, detailed understanding of specific legal terminology, Biogen Idec's position on business and legal terms, and when legal support required.
