Associate Clinical Country & Site Lead

Summary

Join Biogen as a Country/Regionally aligned Clinical Development professional, strategically focused on leveraging local operational and scientific expertise to drive clinical development strategy. You will collaborate with global teams, investigators, and CROs to ensure the successful execution of clinical trials, prioritizing quality and patient safety. This role demands strong communication, organizational, and project management skills, along with a deep understanding of clinical research and regulatory requirements. You will serve as a key point of contact for various stakeholders, managing relationships and ensuring timely information flow. The position requires a science background, minimum 5 years of clinical research experience, and a proven ability to handle multiple tasks effectively. Biogen offers a supportive and inclusive work environment with opportunities for growth and development.

Requirements

• University degree or the equivalent combination of education with a science background and experience
• Minimum 5 years clinical research experience
• Understanding of cross-functional drug development process and high scientific/clinical knowledge across key therapeutic areas enabling aCCSL to discuss compound (s), development plans, and protocol endpoints with investigator site personnel
• 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
• Strong communication skills, including English language skill
• Ability to assimilate new knowledge rapidly

Responsibilities

• Provide global teams with detailed local operational and scientific knowledge to inform the overall clinical development strategy
• Ensure that local opportunities and needs are thoughtfully integrated into operational plans
• Serve as a single point of contact for Investigators, affiliate office staff, CRO staff, and QSDO/global teams
• Enable the delivery of local clinical trials with focus on quality, patient safety, and oversight of CRO activities and performance
• 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, so that these may be communicated to the appropriate Biogen responsible party
• Maintain up-to-date local knowledge of therapeutic/ disease areas researched by Biogen, standards of care, clinical trial requirements and trial-related needs of clinicians in community
• Provide and manage investigator and site knowledge/relationships to highlight country-level capabilities, interests, needs and satisfaction levels
• Develop a country level QSDO investigator engagement strategy, or execution of a global strategy (in collaboration with WM or local medical), as applicable, to position Biogen as the company partner of choice for clinical trials
• Support local activities as part of agreed country and site selection process to ensure appropriate input is sought from local treating physicians and other stakeholders
• Act as primary country-level QSDO/Biogen contact accountable for strategic development and execution of country activities related to the required sponsor oversight of CRO and clinical trial activities, to include, but not limited to; Sponsor Oversight Visits (SOV), audits and inspection support
• Act as 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 staff, and GCO/global teams
• Monitor, analyze and understand overall trial and country progress to support QSDO deliverables and country level goals, as applicable
• Support local or regional projects or other CSO activities as a representative of their country(ies)

Preferred Qualifications

• Experience managing clinical trial activities
• Sponsor oversight activities in an outsourced /FSP model with CROs/vendors
• Customer-focused, with excellent interpersonal skills, cultural awareness, high emotional intelligence and a collaborative decision-making approach
• Proven ability to handle a high volume of tasks of varying complexity within a given timeframe and in consideration of relative priorities