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Contract Law Attorney / Health Care Attorney in Cambridge, MA

Biogen Aug 15,2017 Aug 09,2017 Location USA Cambridge MA
This job is expired...

In-House

Attorney

Corporate - Contract Law

Health Care

Min 6 yrs required

Profile

Senior Specialist, Clinical Contracts The candidate will provide budget build and site contract support for Phase I - IV clinical trials and scientific research collaborations with focus on Early Phase programs. Provide study level support from the trial planning stage, as well as throughout the lifecycle of a clinical trial, providing planning, budget and site contract strategy, resolution and escalation of contract and budget issues and maintaining oversight of company’s Strategic Partner & Legacy CROs to ensure compliant and timely execution of site contracts. Responsible for adherence to all processes and guidelines along with CRO relationship management acting as a subject matter expert in budget building and the resolution of budget questions. May take on other site contract related supporting activities to ensure smooth and efficient functioning of SCM group (e.g. site budget build and direct management of trials where a non-strategic partner / preferred provider CRO is engaged). Provide compliant budget build expertise and consistent budget strategy, oversight, and support at both the program and study. Provide budget guidance in the early stages of trial planning. Oversee and take direct responsibility for the build, development and approval of global investigative site budgets (GrantPlan) with particular emphasis on Early Phase Studies and Programs. Act as an SME to establish country level budget strategy, monitor trends and refine existing guidance, tools, and templates. Act as an SME in the resolution of budget issue escalations working closely with the appropriate functional teams to deliver a solution. Provide support and supervision to the SCM group on development and approval of site budgets. Provide support to the SCM group through direct site negotiation as required by the operating model. Monitor Budget KPIs, including cycle times to ensure adherence to established study timelines. Audit Investigator payments to ensure timeliness, accuracy, and compliance with terms of CTA and tax requirements. Attend Study Management Team meetings on an “agenda-driven” basis, e.g. when strategic decisions that impact site budgets are being discussed. Monitor Investigator payments to ensure timeliness, accuracy, and compliance with terms of CTA through oversight, metrics review and attendance at study monthly meetings. Manage issues and risks by acting as a single point of contact within GCO for site budget challenges and evaluating investigative site budget escalations. Independently handle budget escalations and providing oversight to negotiations escalated by CROs to expedite the delivery of a pragmatic solution. Liaise with the R&D Compliance, Legal and COQO on budget escalations outside the remit of the budget hub. Develop and continually review site contract or investigator budget related Standard Operating Procedures, Work Instructions, or Job Aids through Process Owner Network. Initiate, develop and support the implementation of process improvements for Budget development and negotiation. Provide consistent site contract strategy, oversight, and support to the Sr. Contract Managers at the study level for select priority and complex studies. Review, advise and negotiate, where applicable, site contract template language. Oversee and manage issues and risks for individual studies by addressing contracting challenges and evaluating investigative site budget escalations raised by SOLs. Coordinate the escalation to the R&D Legal counsel of general legal issues outside the remit of the legal hub. Develop and monitor KPIs, including cycle times and SIV targets, to ensure adherence to established study timelines. Provide operational review of specific studies. Oversee and manage the engagement of CCLs and CROs, as applicable, to resolve late payment and invoice issues. Interact with CPSL and CCM teams on study specific questions, develop strategies for resolution of portfolio -wide contract issues. Lead communications with Study teams regarding contracting issues. Participate in on-going process improvement workstreams.

Qualification and Experience

Bachelor’s degree required, MBA/MPA/MPH/JD (or equivalent) preferred. 6+ years of experience in the biotechnology/pharmaceutical industry within the site contracting outsourcing space and fully proficient in project management and either site contract drafting and negotiation and/or site budget development and negotiation and execution across Phase I-IV clinical trials required. Experience in Clinical Operations and have a thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines required. Excellent negotiation skills, conflict resolution, decision making skills, communication (oral and written) and presentation skills required.

Additional info

Job ID: 32093BR

Company info