Lead Clinical Contracts Manager

Recruiter
Biogen Idec
Location
Holyport, UK
Salary
Competitive
Posted
15 Sep 2019
Closes
28 Sep 2019
Ref
1236763189
Sector
Legal
Contract Type
Permanent
Hours
Full Time
Lead Clinical Contracts Manager
UK-Maidenhead SummaryThis role is part of the larger Site Contracts Management (SCM) group that is accountable for the execution of Clinical Trial Agreements between Biogen and Study Sites governing the conduct of clinical trials. The SCM group works in close collaboration with both internal and external partners to fulfill group goals.Job CategoryMedical AffairsRequisition Number38364BRJob DescriptionThe. Manager, SCM provides consistent site contract strategy, oversight, and support at the study level for all operating models (Strategic CRO Partner(s), Legacy CROs and/or in house operating model) by:• Contribute to strategic planning specific to the assigned studies• Contribute to the development of global investigative site budgets (GrantPlan)• Monitoring KPIs, including cycle times and SIV targets, to ensure adherence to established study timelines. • Monitoring Investigator payments made by Strategic Partner and Legacy CROs to ensure timeliness, accuracy, and compliance with terms of CTA and tax requirements• Attending Study Management Team meetings on an "agenda-driven" basis, i.e. when strategic decisions that impact site contracts are being discussed• Managing issues and risks by acting as an escalation point of contact for assigned studies within GCO for site contracting challenges• Serving as a point of contact to address site payment/budget terms escalations• Oversight of payments to sites administered by GCO Strategic Partner & Legacy CROs• Apprising Program Site Contract Manager of study progress• May support the Program Site Contract Manager in his/her program lead responsibilities for select studies or programsIn addition to study oversight, the Manager, SCM may also serve in either of the site outsourcing core centers of focus as detailed below:Language Hub SupportProvides site contracts language support to GCO Strategic Partner & Legacy CROs by:-Acting as a regional SME to provide input on country level contracts strategy, provide site contract language support and guidance regarding escalations, monitor trends and refine existing guidance, tools, and templates to empower Biogen's Strategic Partner and Legacy CROs.- Managing all key clause/new BIIB obligation site contract language negotiations escalated by CRO to expedite the delivery of a pragmatic solution.- Liaising with Biogen R&D Legal counsel on legal escalations outside the remit of the Language Hub.Process Improvement Initiatives- Proactively raises opportunities for process improvements. People Management & Resource PlanningProvides management and development of the Site Contract Management team by: • Managing contractor-based staff in collaboration with FSP providers as appropriate and ensure contractor deliverables are in accordance with expectations• Serving as a point of contact on Biogen policies and processes to contractor-based staffQualifications• A minimum of 6 years' experience in the biotechnology/pharmaceutical industry within the site contracting outsourcing space and fully proficient in project management and site contract and budget negotiation and execution across Phase I-IV clinical trials. • Must have experience in Clinical Operations and have a thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines.• Excellent negotiation skills, conflict resolution, decision making skills, communication (oral and written) and presentation skills.• Strong organizational skills, including the ability to prioritize needs and handle a high volume of tasks within a given timeframe.EducationBachelor's Degree and combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities for this position. Bachelor's degree required, MBA/MPA/MPH/JD (or equivalent) preferred but not required.Employment CategoryFull-Time Regular Experience LevelMid-Senior Level

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