Sr. Manager/AD, Clinical Operations | REMOTE | Pre-IPO
Senior Manager/Associate Director, Clinical Operations
Overview
Our client 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 clinical trials. This role includes oversight of Clinical Research Associates (CRAs), development of study operational plans, conducting onsite initiation and monitoring visits, and tracking key clinical quality indicators to support effective trial execution.
Responsibilities
ā¢ Manage the organizationās in-house CRAs across key clinical programs.
ā¢ Develop high-quality study operational manuals and plans, including a Clinical Monitoring Plan and a Protocol Deviation Handling Guide, and oversee compliance with these plans.
ā¢ Review and contribute to the development of study protocols, informed consent forms, pharmacy manuals, eCRF entry manuals, eTMF and filing plans, as well as other study-related plans and guidance.
ā¢ Review IP release checklists, protocol deviations, aging action items, critical queries and query aging, and other clinical trial operational data; identify issues and implement solutions.
ā¢ Review and approve monitoring trip reports.
ā¢ Perform onsite visits with CRAs, including site initiation visits and interim monitoring visits.
ā¢ Lead the development and delivery of clinical operations training for studies, including CRA training, study coordinator training, investigator meeting training, and SIV training.
ā¢ Participate in site feasibility and selection by reviewing site qualifications and assessing facility capabilities, staff qualifications, and the siteās ability to conduct the protocol.
ā¢ Ensure timely document collection and filing in the electronic Trial Master File (eTMF), including administering and controlling access, filing documentation, and performing quality control (QC).
ā¢ Lead real-time storyboard creation in partnership with Quality Assurance as part of the organizationās inspection readiness program.
ā¢ Develop Key Clinical Quality Indicators that provide insight into and identify risks related to clinical monitoring activities and site protocol adherence. Implement weekly monitoring of these indicators and establish processes for proactively escalating and resolving issues.
Qualifications
ā¢ Some travel required, approximately 30%, though this may vary (for example, increased travel during startup and database lock).
ā¢ 8+ years of clinical operations experience, including experience directly managing CRAs.
ā¢ Experience with and strong command of all key aspects of clinical trial operations.
ā¢ Demonstrated ability to prioritize, organize, plan, and achieve results across multiple projects simultaneously.
ā¢ Self-starter with a strong sense of ownership and the ability to work autonomously.
ā¢ Interest in working within a lean, fast-paced, and nimble environment, with comfort managing uncertainty and contributing hands-on to achieve results.
ā¢ Experience working with technical documentation, including reviewing ICFs, filing in eTMF, and drafting study plans and related materials.
ā¢ BA/BS degree or equivalent.
Apply Now
Apply Now
Overview
Our client 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 clinical trials. This role includes oversight of Clinical Research Associates (CRAs), development of study operational plans, conducting onsite initiation and monitoring visits, and tracking key clinical quality indicators to support effective trial execution.
Responsibilities
ā¢ Manage the organizationās in-house CRAs across key clinical programs.
ā¢ Develop high-quality study operational manuals and plans, including a Clinical Monitoring Plan and a Protocol Deviation Handling Guide, and oversee compliance with these plans.
ā¢ Review and contribute to the development of study protocols, informed consent forms, pharmacy manuals, eCRF entry manuals, eTMF and filing plans, as well as other study-related plans and guidance.
ā¢ Review IP release checklists, protocol deviations, aging action items, critical queries and query aging, and other clinical trial operational data; identify issues and implement solutions.
ā¢ Review and approve monitoring trip reports.
ā¢ Perform onsite visits with CRAs, including site initiation visits and interim monitoring visits.
ā¢ Lead the development and delivery of clinical operations training for studies, including CRA training, study coordinator training, investigator meeting training, and SIV training.
ā¢ Participate in site feasibility and selection by reviewing site qualifications and assessing facility capabilities, staff qualifications, and the siteās ability to conduct the protocol.
ā¢ Ensure timely document collection and filing in the electronic Trial Master File (eTMF), including administering and controlling access, filing documentation, and performing quality control (QC).
ā¢ Lead real-time storyboard creation in partnership with Quality Assurance as part of the organizationās inspection readiness program.
ā¢ Develop Key Clinical Quality Indicators that provide insight into and identify risks related to clinical monitoring activities and site protocol adherence. Implement weekly monitoring of these indicators and establish processes for proactively escalating and resolving issues.
Qualifications
ā¢ Some travel required, approximately 30%, though this may vary (for example, increased travel during startup and database lock).
ā¢ 8+ years of clinical operations experience, including experience directly managing CRAs.
ā¢ Experience with and strong command of all key aspects of clinical trial operations.
ā¢ Demonstrated ability to prioritize, organize, plan, and achieve results across multiple projects simultaneously.
ā¢ Self-starter with a strong sense of ownership and the ability to work autonomously.
ā¢ Interest in working within a lean, fast-paced, and nimble environment, with comfort managing uncertainty and contributing hands-on to achieve results.
ā¢ Experience working with technical documentation, including reviewing ICFs, filing in eTMF, and drafting study plans and related materials.
ā¢ BA/BS degree or equivalent.
Apply Now
Apply Now