Clinical Country and Site Lead

This is a fieldbased 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 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 Youll 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 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 of country activities related to the required sponsor oversight of clinical trial monitoring activities (e.g. Sponsor Oversight Visits 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. 3050 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 Country

Who You Are

You are an experienced research professional with strong site management experience. You excel in building effective site relationships driving site performance and ensuring quality 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.

Qualifications :

Required Skills

• University degree or the equivalent combination of education with a science background and experience required; advanced/graduate degree preferred from a scientific background. 
• Minimum 8 years clinical research experience. Experience managing clinical trial activities desirable especially sponsor oversight activities in an outsourced/FSP model with CROs/vendors. 
• Understanding of cross functional drug development process and high scientific/clinical knowledge across key therapeutic areas. 
• Understanding of ICH/GCP applicable country regulations and clinical trial monitoring in an outsourced model. 
• Strong organizational skills especially project management skills with an ability to set clear goals align priorities and execute on multiple tasks/activities. 
• Effective working knowledge of relevant IT tools to promote virtual team working. 
• Excellent knowledge of clinical operational activities/challenges across local geography. 
• The ideal candidate will be customer focused with leadership skills interpersonal skills cultural awareness high emotional intelligence and a collaborative decisionmaking approach. Must build relationships throughout and across the organization whilst operating remotely. 
• Proven ability to handle a high volume of tasks of varying complexity within a given timeframe and in consideration of relative priorities. 
• Strong communication skills including English language skill in countries where English is not the primary language. Ability to assimilate new knowledge rapidly. 
• Travel requirement 20

Preferred Skills

• Experience working in a fully outsourced and Functional Service Provider (FSP) models

Additional Information :

Why Biogen

We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver lifechanging medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an EVerify Employer in the United States.