Think Beyond The Label Jobs

Overview The Study Operations Manager supports the operational and logistical activities involved in clinical studies at Myriad, primarily those involving minimal residual disease. This role requires a strong background in process development and project management, ideally in a biotech setting, as well as the ability to develop and maintain strong collaborative and cooperative working relationships with team members across different functions and at different levels within and external to the organization. Responsibility * Leads the operational planning, implementation, and tracking of multiple studies and research-related workstreams including study start-up, sample logistics and tracking, communication of important milestones, and other related processes. * Creates comprehensive project plans and timelines and assists in budget development for clinical studies. * Develops and maintains standardized processes related to comprehensive research sample and data management while maintaining compliance with regulatory requirements and company standards, including coordinating the collection and transport of samples, establishing tracking and inventory processes, ensuring proper storage and handling, maintaining complete documentation, and providing timely updates to stakeholders on sample shipments, storage status, and any issues or concerns related to sample handling or transportation. * Collaborate with study supply vendors to ensure the timely procurement and delivery of materials necessary for study kit creation. Establish and maintain effective relationships with vendors, negotiate contracts and pricing, and monitor vendor performance to ensure compliance with service agreements. * Maintains a high level of expertise in assigned areas (e.g., operational aspects of clinical sample testing) including familiarity with applicable SOPs, regulatory requirements, industry standards and other internal policies related to the conduct of clinical studies and projects. * Plans and leads team meetings regarding study operations and logistics. * Identifies potential risks and issues that may impact the successful completion of clinical studies and projects. Develops risk mitigation strategies and contingency plans to address challenges proactively. * Participates in discussions/interactions with external collaborators and key opinion leaders. Qualifications * Required Education/Credentials: * Minimum bachelor's degree in life science or related field. * Minimum of three years of experience in biomedical or research and development settings (public or private). * Required Experience/Skills: * Experience in clinical study operations and logistics, including multi-site, prospective studies involving sample collection, storage, and processing. * Experience in clinical study conduct, including Good Clinical Practice (GCP) and FDA regulatory requirements. * Strong organizational and time management skills, with the ability to simultaneously track multiple projects. * Highly detail-oriented, with... For full info follow application link.

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