Senior Regional Clinical Expert

6 days ago

Sydney, New South Wales, Australia beBeeClinicalCountry Full time $100,000 - $150,000
Job Title: Clinical Country

This is a field-based country/regionally aligned role, strategically focused on providing key local operational and scientific expertise to drive global clinical development strategy.

The CCSL will provide global teams with detailed local operational and scientific knowledge that will inform the overall clinical development strategy and ensure that local opportunities and needs are thoughtfully integrated into operational plans.

The CCSL role will provide operational direction and prioritize activities for CCSA resources to deliver local clinical trial quality and oversight of CRO activities, with focus on performance.

  • 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 GCO 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.
  • Primary country-level GCO/Biogen contact accountable for strategic development and execution of country activities related to the required sponsor oversight of CRO and clinical trial activities.
  • Act as Lead CCSL required, coordinating Program and Study Country Foundation, investigator assessment of (and feedback on) programs and protocols, and Site Selection activities.
  • Primary country-level GCO/Biogen contact for all GCO clinical studies, leading interactions or managing CCSA interactions to ensure timely local information flow and resolution of issues as appropriate with Investigators, affiliate office staff, CRO staff, and GCO/global teams.
  • Understand, analyze, and monitor overall Country Performance (KPIs) and support country-focused activities to deliver country operational milestones.

Required Skills and Qualifications:

  • Deep understanding of cross-functional drug development process and high scientific/clinical knowledge across key therapeutic areas enabling CCSL to discuss compound, development plans, and protocol endpoints with investigator site personnel.
  • Strong organizational skills, especially project management skills, with an ability to set clear goals, align priorities, and lead 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.
  • Must have strong leadership skills, with the ability influence and drive performance.

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