Clinical Study Manager
The Clinical Study Manager (CSM) is responsible for developing, implementing and executing clinical studies from early to late-stage-development in different therapeutic areas. Working in a global team setting where effective interaction with highly skilled colleagues, and with internal and external stakeholders, is critical. Provide scientific input into company activities for the assigned therapeutic area(s) to facilitate and advance global clinical development of product candidates.
What you’ll dive into
• Manage all operational aspects of global clinical studies from initial study concept to final report within the scope of the company’s development plan (including budgets and timelines)
• Proactively identify/resolve operational issues to ensure achievement of study milestones, data quality and data integrity
• Coordinate and oversee the development of study protocols and amendments, and cooperate in the development of other essential documents for clinical studies, providing expert scientific input throughout.
• Support evaluation and selection of Clinical Research Organizations (CROs) and manage CROs in the conduct of assigned clinical studies
• Ensure compliance with GCP and SOPs
• Write and/or review clinical sections of clinical/statistical reports, including investigator’s brochures, INDs and NDA, and other clinical trial and regulatory submissions, as required
What we expect
• Minimum of a Bachelor’s degree, Masters or Doctorate degrees preferred
• Must have 6-10 years of pharmaceutical industry experience with a minimum of 4 years in clinical operations or related experience
• Demonstrated knowledge of the drug development process, Health Authority regulations and ICH GCP technical aspects of clinical study conduct
• Must have excellent communication skills and be able to establish and maintain relationships with various intra-department and inter-department personnel
• Must be able to work with remote team members across different time zones, in a virtual team environment
What you’ll get
• To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
• Opportunities to learn and contribute creative solutions
• Comprehensive health insurance ($0 premium on select medical plans)
• Matching 401k retirement plan
• Paid time off and holidays including a Summer & Winter break
• Company celebrations
Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at firstname.lastname@example.org.