Clinical Country and Site Lead

This is a field-based country aligned role, strategically focused on providing key local operational and scientific expertise to drive global clinical development strategy, enable local partnerships that enhance global customer satisfaction (internal and external), and support the country focused delivery and execution of the R&D pipeline. The Clinical Country and Site Lead (CCSL) role will provide global teams with detailed local operational and scientific knowledge to inform the overall clinical development strategy and will ensure that local opportunities and needs are thoughtfully integrated into operational plans.   At the country level, this role serves as a single point of contact for CRO staff, and QSDO/global teams. This is to enable the delivery of local clinical trials with focus on quality, patient safety, and oversight of monitoring activities and performance. The CCSL role will also serve as a site escalation point for investigator concerns, including those related to data integrity, patient safety or issues which are unresolved by the CRO, for example, ensuring that these are communicated to the appropriate Biogen responsible parties. As assigned, the CCSL may interact with FSP resources and support monitoring operations. The CCSL role may also provide operational direction and support prioritization of associate CCSL (aCCSL) resources.What You’ll Do Maintain current awareness/information pertaining to local clinical knowledge of disease areas researched by Biogen, emerging standards of care, and trial related needs of clinicians in community.  Hold specific operational and scientific discussions and act as local QSDO expert for the provision of country level therapeutic area, disease area, and program and study information to drive and support global operational strategy. Coordinate cross functional local affiliate input as required to provide appropriate country level input into Clinical Development Plan.Provide and manage investigator and site knowledge/relationships to highlight country level capabilities, interests, needs and satisfaction levels.  This would involve the development of a country level QSDO investigator engagement strategy, or execution of global strategy (in collaboration with WM or local medical) to position Biogen as the company partner of choice for clinical trials. Primary country level QSDO/Biogen contact accountable for strategic development and execution of country activities related to the required sponsor oversight of clinical trial monitoring activities (e.g. Sponsor Oversight Visit’s, audits, and inspection support).  The Role may interact with FSP resources and may also support monitoring operations, as assigned.  Act as Lead CCSL, as required. This includes but is not limited to membership in CDT and SMT(s), coordinating Program and Study Country Foundation, investigator assessment of (and feedback on) programs and protocols, and Site Selection activities. Also responsible for training CCSLs on therapeutic area and program, program and trial level communications, and ownership of CSO activities related to a given program or trial. (30-50% if serving in the role, depending on phase of program).Primary country level QSDO/Biogen contact for all QSDO clinical studies, leading interactions to ensure timely local information flow and resolution of issues as appropriate with Investigators, affiliate office staff, CRO/FSP staff, and QSDO/global teams.  Understand, analyze and monitor overall Country Performance (KPIs) and support country focused activities to deliver country operational milestones Lead and manage required local activities as part of agreed country and site selection process to ensure appropriate input is sought from local treating physicians and other stakeholders, [e.g. investigator assessment of (and feedback on) programs and protocols]May provide operational direction for activities of assigned associate CCSL (aCCSL)Support special projects or other QSDO activities as a representative of CSO or CountryWho You AreYou are an experienced research professional with strong site management experience. You excel in building effective site relationships, driving site performance, and ensuring quality execution of clinical trials. The ideal CCSL is highly collaborative and able to work cross functionally to support study start up, site engagement initiatives, resolve site challenges and maintain oversight throughout the trial lifecycle.