Senior Clinical Trial Manager (Remote)

Description

The Senior Clinical Trial Manager (CTM) is accountable for the day-to-day activities related to the planning and execution of assigned clinical trials including vendor management and sponsor oversight activities. The Sr. CTM 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 study protocol, Good Clinical Practices (GCPs) and Guidelines, International Council for Harmonization (ICH) requirements while aligning with Elevar SOPs. This role will ensure the highest level of data quality and compliance to quality standards and regulatory guidance, proactively identify, communicate, and resolve clinical study operational issues, and participate in process improvement initiatives as required.

This is a remote-based position located in the United States.

• Collaborate with the operational project team members and Finance stakeholders to manage clinical study vendor(s) to ensure compliance with the contracted study specifications (i.e., timelines, deliverables) of the assigned clinical trial(s)
• Lead the Clinical Operations team (CRAs and CTAs, as applicable) and cross-functional clinical trial team in the planning, execution, and reporting of clinical trials ensuring alignment of activities with study timelines, budgets, SOPs, ICH, GCPs, and applicable regulatory requirements
• Proactively identify and resolve operational issues/processes to ensure achievement of study milestones, data quality, and data integrity; escalates study-related issues appropriately to Clinical Operations leadership in a timely manner
• Interact with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Drug Safety and Pharmacovigilance, Clinical Supply, and Clinical vendors (e.g., central lab, CROs, imaging vendors) to support clinical trial activities
• Manage clinical study timelines, budget by utilizing the appropriate project management tools, select and manage vendors, manage vendor contracts, and ensure expenditures are within budgetary guidelines
• Ensure recruitment targets are met and review enrollment at the site level including responsibility for coordinating the approval of enrollment exceeding above site targets per protocol/contract with senior management; responsible for coordinating contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan
• Organize and manage internal and external team meetings, investigator meetings, and other trial specific meetings
• Develop and/or facilitate the development of the Sponsor study oversight plan, including study plans and documents, as required; review site study documents (e.g., informed consent template and study tools/worksheets), investigator contracts, and site payments as required; accountable for Sponsor Oversight Activities (e.g., trip report view, CRO oversight monitoring visits, ensuring adherence to clinical study plans)
• Participate in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
• Support and/or facilitate the training of junior level Clinical Operations members
• Maintain and ensure TMF and TMF documentation is in a state of audit-readiness and is thoroughly QC’d by cross-functional members at study closure
• Support Clinical Operations in audit and inspection readiness activities
• May be responsible to perform other related duties as assigned. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time

Description

The Senior Clinical Trial Manager (CTM) is accountable for the day-to-day activities related to the planning and execution of assigned clinical trials including vendor management and sponsor oversight activities. The Sr. CTM 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 study protocol, Good Clinical Practices (GCPs) and Guidelines, International Council for Harmonization (ICH) requirements while aligning with Elevar SOPs. This role will ensure the highest level of data quality and compliance to quality standards and regulatory guidance, proactively identify, communicate, and resolve clinical study operational issues, and participate in process improvement initiatives as required.

This is a remote-based position located in the United States.

• Collaborate with the operational project team members and Finance stakeholders to manage clinical study vendor(s) to ensure compliance with the contracted study specifications (i.e., timelines, deliverables) of the assigned clinical trial(s)
• Lead the Clinical Operations team (CRAs and CTAs, as applicable) and cross-functional clinical trial team in the planning, execution, and reporting of clinical trials ensuring alignment of activities with study timelines, budgets, SOPs, ICH, GCPs, and applicable regulatory requirements
• Proactively identify and resolve operational issues/processes to ensure achievement of study milestones, data quality, and data integrity; escalates study-related issues appropriately to Clinical Operations leadership in a timely manner
• Interact with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Drug Safety and Pharmacovigilance, Clinical Supply, and Clinical vendors (e.g., central lab, CROs, imaging vendors) to support clinical trial activities
• Manage clinical study timelines, budget by utilizing the appropriate project management tools, select and manage vendors, manage vendor contracts, and ensure expenditures are within budgetary guidelines
• Ensure recruitment targets are met and review enrollment at the site level including responsibility for coordinating the approval of enrollment exceeding above site targets per protocol/contract with senior management; responsible for coordinating contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan
• Organize and manage internal and external team meetings, investigator meetings, and other trial specific meetings
• Develop and/or facilitate the development of the Sponsor study oversight plan, including study plans and documents, as required; review site study documents (e.g., informed consent template and study tools/worksheets), investigator contracts, and site payments as required; accountable for Sponsor Oversight Activities (e.g., trip report view, CRO oversight monitoring visits, ensuring adherence to clinical study plans)
• Participate in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
• Support and/or facilitate the training of junior level Clinical Operations members
• Maintain and ensure TMF and TMF documentation is in a state of audit-readiness and is thoroughly QC’d by cross-functional members at study closure
• Support Clinical Operations in audit and inspection readiness activities
• May be responsible to perform other related duties as assigned. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time

Requirements

• BA/BS degree or equivalent years of experience preferably in Life Sciences
• At least 5+ years of clinical trial work experience, with a minimum of 4 years having effectively managed a clinical study from inception to completion; remote or on-site monitoring is desirable (CRO/industry experience is acceptable)
• Knowledge of ICH/GCP guidelines, including interpretation and implementation of FDA regulations
• Ability to work in a fast-paced environment and navigate unexpected events
• Demonstrated ability to lead and motivate cross-functional teams
• Essential time management and project management skills
• Proven experience in managing global clinical trials, preferably in Oncology
• Proficient with Microsoft Office applications, Adobe Acrobat, PowerPoint, and use of electronic document templates
• Excellent organizational and interpersonal skills
• Willingness to travel for business, approximately 10%-20%
• Ability to demonstrate Elevar’s core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making space for ingenuity in work and thought, and staying grounded in compassion

The anticipated annual base salary range for this role is $170,000 to $187,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, and external market factors. Elevar Therapeutics is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, time off, a retirement plan, and other voluntary benefits for employees.