With minimal direction, the Senior Clinical Trial Manager (CTM) is responsible for management and delivery of all clinical aspects of Aerovate sponsored clinical trials to ensure compliance with the Clinical Protocol, Standard Operating Procedures (SOPs), Good Clinical Practices and ICH Guidelines.
WORK EXPERIENCE REQUIREMENTS
Accountable for the delivery of assigned clinical trial(s), budgets, and timelines, with a focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives.
Lead and manage day-to-day execution of assigned clinical trials to ensure all trial deliverables are met according to established timelines, goals, budget, and quality standards.
Manage the cross-functional study management team and CRO/vendor(s) related to all aspects of clinical trial operations and continuously assess operational performance through carefully designed performance and quality indicators
Select and assist in the identification, RFP/bid defense, and selection of CRO/third party vendors
Contribute to the development of documents including the clinical trial protocol, Investigator’s Brochures, Informed Consent Forms, Case Report forms, responses to questions from IRBs and Ethics Committees. Contribute to clinical sections of IND summary documents, CTAs for initiation of studies ex US, and responses to questions from regulatory authorities
Ensure that site personnel have an appropriate understanding of the protocol, the investigational product and the requirements of the study to fulfill their obligations to conduct the study accurately and timely
Lead and manage study team comprised of internal and external team members and resources (CRO, Consultants, CRAs)
Develop strong relationships with Investigators, site staff, and CRO partners.
Contribute to Clinical Operations/Organizational initiatives to build and optimize business procedures, tools, and guidance.
Strong organizational skills and attention to detail with ability to work in a fast paced environment and flexibility with respect to prioritization of daily tasks and projects
Ability to work both independently with direction and within project teams
Excellent written and oral communication and interpersonal skills
Proactive operational planning with effective contingency and risk mitigation plan
Aides in the training and development of all clinical staff members
Proactively identifies and resolves issues, and participates in process improvement initiatives as required
Monitor CRO and vendor adherence to the scope of work
Proactively identify, resolve and escalate issues that jeopardize timely clinical study completion
Develop internal tracking and reporting tools for reporting study status to Leadership
May require travel (up to 20%)
Minimum 6-8 years industry experience within clinical research/operations
Experience in managing Clinical Research Organizations (CROs), vendors, and contractors in all phases of
clinical trial execution (Start-up, maintenance, closeout)
Strong understanding of ICH and GCP guidelines and applicable regulations
Excellent interpersonal, verbal and written communication skills
Job Type: Full-time
Pay: $20,000.00 - $500,000.00 per year
- Monday to Friday
Work Location: Remote