Senior Clinical Trial Manager (Remote)

Elevar Therapeutics, Inc.; United States; Remoto; USD 170.000 - 187.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Dental insurance

Vision insurance

Retirement plan

Time off & benefits

Descrizione del lavoro

Elevar Therapeutics, Inc. is seeking a Senior Clinical Trial Manager for a remote-based role in the United States.

The candidate will oversee day-to-day planning and execution of clinical trials, including vendor oversight, sponsor oversight, and data quality, ensuring milestones are met in compliance with ICH/GCP and regulatory requirements. Responsibilities include leading the Clinical Operations team, coordinating cross-functional stakeholders, managing timelines and budgets, and ensuring

Competenze

• BA/BS degree or equivalent years of experience.
• At least 5+ years of clinical trial work experience, with a minimum of 4 years managing a trial from inception to completion (remote or on-site monitoring acceptable).
• Knowledge of ICH/GCP guidelines and FDA regulations.
• Ability to work in a fast-paced environment and handle unexpected events.
• Demonstrated ability to lead and motivate cross-functional teams.
• Essential time management and project management skills.
• Proven experience managing global clinical trials, preferably in Oncology.
• Proficiency with Microsoft Office applications, Adobe Acrobat, PowerPoint, and electronic templates.
• Excellent organizational and interpersonal skills.
• Willingness to travel ~10–20%.
• Ability to embody Elevar’s core values in remote collaboration.

Mansioni

• Collaborate with project team members and Finance to manage trial vendors to meet timelines and deliverables.
• Lead the Clinical Operations team and cross-functional trial team to plan, execute, and report trials in alignment with timelines, budgets, SOPs, ICH/GCP, and regulatory requirements.
• Identify and resolve operational issues to ensure milestones, data quality, and data integrity; escalate as needed.
• Coordinate with Clinical Development, Data Management, Regulatory, QA, Drug Safety, and vendors to support trial activities.
• Manage study timelines and budgets, select and manage vendors, and monitor expenditures within budget.
• Ensure recruitment targets are met and review enrollment at site level; coordinate contingency plans if targets are not met.
• Organize meetings including investigator meetings; facilitate sponsor oversight discussions and site documentation reviews.
• Participate in training and evaluation of study personnel to ensure efficient operation of the function.
• Support TMF documentation readiness and audit readiness at study closure.
• Assist in audit and inspection readiness activities.

Conoscenze

Leadership

Project management

GCP/ICH knowledge

Communication

Time management

Formazione

BA/BS degree or equivalent

Strumenti

MS Office

Adobe Acrobat

Descrizione del lavoro

All Jobs > Senior Clinical Trial Manager (Remote)

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.

Responsibilities

• 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.