Clinical Study Manager
The Clinical Study Manager is accountable for all operational activities related to planning, executing/conducting and reporting out of assigned clinical study(ies) in support of AnaptysBio product development portfolio. The Sr. CSM/CSM will independently organize and manage multiple activities related to clinical studies, while simultaneously ensuring study milestones are met and studies are completed in accordance with the protocol and ICH/GCP requirements. Duties involve contributions to multiple clinical studies of differing phases, project planning, budgeting, participating in the selection of clinical sites, selection and management of clinical vendors, organizing and conducting Investigator Meetings, making clinical presentations, etc. The successful candidate drives the conduct of the study, maintains study level reporting systems, progress reports and trackers to ensure all study operational aspects are on track in support of AnaptysBio clinical programs.
- Working knowledge of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs
- Proven ability to plan, conduct and manage clinical operations from early through late phase trials, with global trial experience is preferred.
- Demonstrated ability to manage CROs, central laboratories, and other clinical study vendors.
- Ability to contribute to the development of clinical protocols, project-related documents, clinical study reports and summary documents for regulatory submissions.
- Demonstrated ability to handle a high volume of highly complex tasks within a given timeline
- Demonstrated, effective planning and project management skills, including risk assessment, contingency planning and ability to prioritize.
- Effective communication and interpersonal skills, with the ability to successfully articulate plans, results and analysis to project teams and senior management to build commitment and alignment; listens and seeks clarification; responds effectively to inquiries or complaints.
- Ability to build strong relationships with external parties, such as key opinion leaders and clinical investigators.
- Excellent organizational and problem-solving skills with the capacity to organize assignments and work within deadlines
- BA/BS in related scientific or healthcare field and
- Minimum of 6 years of clinical operations experience gained working in a pharmaceutical/biotechnology industry environment, with a strong preference for immunology, allergy, dermatology and/or biologics experience;
- CCRA preferred.