What are the responsibilities and job description for the Associate Director Clinical Operations position at Latitude Inc?
Associate Director of Clinical Operations | Hybrid
A clinical-stage biotherapeutics organization is seeking an Associate Director of Clinical Operations to support its growing portfolio of innovative clinical programs. This position offers a hybrid work model, the opportunity to work in a dynamic and collaborative environment, and involvement in cutting-edge immunology and autoimmune research.
Key Responsibilities
• Manage and oversee all operational aspects of assigned clinical studies in alignment with internal SOPs, ICH GCP, applicable laws, and regulatory guidelines.
• Lead and coordinate cross-functional study teams.
• Ensure study deliverables are met with high quality and within agreed timelines.
• Prepare and coordinate clinical study documentation, including protocols, IBs, DSURs, ICFs, and CSRs.
• Select and oversee CROs, contract monitors, and external vendors.
• Participate in clinical site selection with internal teams and CRO partners.
• Conduct periodic co-monitoring to ensure high-quality site monitoring and data integrity.
• Set up and manage clinical contracts, including Clinical Site Agreements.
• Coordinate IRB/IEC submissions and support regulatory submission packages.
• Develop and manage study budgets, forecasting, and accruals.
• Maintain thorough documentation of study decisions, actions, and risk assessments.
• Actively manage clinical supply needs in partnership with third-party distribution specialists.
• Oversee Sponsor Oversight Files and/or TMF creation and maintenance to ensure inspection readiness.
• Continuously develop therapeutic area knowledge relevant to assigned studies.
Essential Qualifications
• BSc or equivalent degree.
• Clinical study management experience within pharma, biotech, or CRO settings.
• Proven vendor oversight experience (CROs, central labs, imaging vendors, etc.).
• Strong written, verbal, and presentation skills.
• Excellent organizational, interpersonal, and time-management capabilities.
• Ability to manage multiple priorities across programs.
• Strong working knowledge of GCP and current clinical trial regulations.
• Thorough understanding of the clinical development process from early-phase through regulatory submission.
• Ability to travel domestically and internationally as needed.
• Comfortable working in a dynamic small-team environment.
Desired Skills
• Experience in early-phase (I–II) clinical studies.
• GMO study experience.
• Background as a CRA or clinical monitor.
• Familiarity with EDC, eTMF, and CTMS systems.
• Experience in autoimmune diseases and immunology.