Associate Clinical and Site Lead; West Coast​/Midwest

The Associate Clinical Country and Site Lead (aCCSL) role will support the Clinical Country and Site Lead (CCSL) in providing 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 aCCSL 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 aCCSL may interact with FSP resources and support monitoring operations. 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 Quantitative Sciences & Development Operations (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 Worldwide Medical or local medical) to position Biogen as the company partner of choice for clinical trials.

Lead and/or support required local activities as part of agreed country and sites 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] 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. Support special projects or other QSDO activities as a representative of CSO or Country.

You 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 aCCSL 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.

Bachelor’s degree or equivalent 5+ years clinical research experience including managing clinical trial activities desirable, especially sponsor oversight activities in an outsourced/FSP model. 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.

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. Willingness to travel up to 80% (1x/week).

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

This is a field-based country aligned role,…