Remote Study Management Lead

Summary

Join PicnicHealth, a mission-driven company making a real impact across millions of people's lives, as the Study Management Lead to oversee study management activities, ensure study integrity, patient safety, and regulatory adherence.

Requirements

• Bachelor’s degree in Life Sciences, Nursing, Public Health, or a related field (advanced degree preferred)
• 7+ years of clinical research experience, with a focus on observational studies and/or late-phase research (like long term follow-up studies)
• Comprehensive expertise in study start-up, regulatory affairs, quality assurance, and safety reporting, with experience utilizing AI and innovative technologies in study management
• Proven track record managing complex, multi-site studies and handling numerous studies simultaneously
• Extensive knowledge of GCP, FDA/EMA regulations, and ICH guidelines

Responsibilities

• Leading and executing the study start-up process, ensuring that all regulatory and operational requirements are efficiently met
• Managing submissions to Institutional Review Boards (IRBs) and Ethics Committees, securing timely approvals
• Collaborating with Quality & Regulatory and other internal/external experts (e.g., privacy, legal) to maintain full compliance with relevant regulations (mostly focused on FDA currently with an eye towards global expectations)
• Identifying and onboarding experienced Principal Investigators (PIs), building and maintaining strong relationships to support seamless study execution
• Executing the day-to-day operations of observational studies, ensuring strict adherence to timelines, budgets, and study protocols
• Ensuring all study activities are compliant with applicable aspects of Good Clinical Practice (GCP) and regulatory guidelines
• Developing and implementing study-specific Standard Operating Procedures (SOPs) and plans to optimize operational efficiency and ensure compliance with both company and client standards
• Supporting our Patient Recruitment, Enrollment, & Engagement Team with feasibility, site selection, recruitment, and enrollment activities, as needed, focusing on accelerating start-up timelines
• Contributing to quality assurance efforts, ensuring data integrity and accurate reporting of study outcomes
• Leading safety reporting activities, ensuring adherence to pharmacovigilance requirements, including (Serious) Adverse Event (AE/SAE) reporting and documentation in coordination with Quality & Regulatory Team

Benefits

• Comprehensive benefits including above market Health, Dental, Vision
• Family friendly environment
• Flexible time off
• 401k plan
• Free PicnicHealth account
• Equipment and internet funds for home office set up
• Wellness Stipend