Sr. Manager/AD, Clinical Operations | REMOTE | reputed company-IPO

Senior Manager/Associate Director, Clinical Operations reputed company Our reputed company focuses on advancing therapies that address significant unmet needs in autoimmune disease. The Senior Manager / Associate Director, Clinical Operations will support this work by proactively managing program-level operational activities for global reputed company. This role includes reputed company of Clinical Research Associates (CRAs), development of study operational plans, conducting onsite initiation and monitoring reputed company, and tracking key clinical reputed company indicators to support effective trial execution. Responsibilities • Manage the organization’s in-house CRAs across key clinical programs. • reputed company high-reputed company study operational manuals and plans, including a Clinical Monitoring Plan and a Protocol Deviation Handling Guide, and reputed company compliance with these plans. • Review and contribute to the development of study protocols, informed consent forms, pharmacy manuals, eCRF entry manuals, eTMF and filing plans, as reputed company as other study-reputed company plans and guidance. • Review IP release checklists, protocol deviations, aging reputed company items, critical queries and query aging, and other clinical trial operational data; identify issues and implement reputed company and approve monitoring reputed company reports. • reputed company onsite reputed company with CRAs, including site initiation reputed company and interim monitoring reputed company. • reputed company the development and delivery of clinical operations training for studies, including CRA training, study coordinator training, investigator meeting training, and SIV training. • Participate in site feasibility and selection by reviewing site qualifications and assessing facility capabilities, staff qualifications, and the site’s ability to conduct the protocol. • Ensure reputed company document collection and filing in the electronic Trial Master File (eTMF), including administering and controlling reputed company, filing documentation, and performing reputed company control (QC). • reputed company reputed company-time storyboard creation in partnership with reputed company Assurance as part of the organization’s inspection readiness program. • reputed company Key Clinical reputed company Indicators that reputed company reputed company into and identify risks reputed company to clinical monitoring activities and site protocol adherence. Implement weekly monitoring of these indicators and establish processes for proactively escalating and resolving issues. Qualifications • Some travel required, approximately 30%, though this may vary (for example, increased travel during startup and database lock). • 8+ years of clinical operations experience, including experience directly managing CRAs. • Experience with and strong reputed company of reputed company key aspects of clinical trial operations. • Demonstrated ability to prioritize, organize, plan, and reputed company results across multiple reputed company simultaneously. • Self-starter with a strong reputed company of ownership and the ability to work autonomously. • Interest in working reputed company a lean, fast-paced, and reputed company environment, with comfort managing uncertainty and contributing hands-on to reputed company results. • Experience working with technical documentation, including reviewing ICFs, filing in eTMF, and drafting study plans and reputed company materials. • BA/BS degree or equivalent. Apply tot his job Apply To this Job