- Performs job with minimal supervision
- Management of day-to-day operations of assigned clinical trial(s), leading CRO and vendor teams to ensure completion per established project team goals and in compliance with applicable GCP/ICH guidelines and other regulatory requirements
- Acts as the clinical operations representative in a variety of cross-functional teams
- Collaborates with the program Clinical Operations Lead to develop and manage study level timelines and budgets in accordance with corporate, department, and project goals, working closely with internal leadership and CROs
- Management of overall project budget, participating in regular meetings with Finance team
- Independently manage clinical study vendors tracking quality of deliverables, progress against internal goals, regularly reviewing performance metrics and other Key Performance Indicators
- Collaborate with CRO to identify and develop training needs for site staff, CRAs, and vendors specific to the study protocol and processes, including presenting these at Investigator Meetings and Kick-off meetings
- Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments and CRO, as applicable
- Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
- Responsible for management and/or oversight of eTMF structure, plans and quality, ensuring inspection readiness and serving as primary study management point-of-contact in the event of audit or inspection
- Manage study activities including, but not limited to, investigator selection, study start-up, subject recruitment & retention, data collection, development of study plans, and database locks, study drug accountability and study closeout.
- Actively contribute to technical and study design discussions, providing input toward clinical trial outlines, protocols, informed consent forms, and clinical study reports.
- Collaborate with CRO and/or vendor in build of study eSystems (IXRS, ePRO, EDC, etc.), leading User Acceptance Testing and overseeing subsequent updates through the life of the trial
- Identify issues and risks with cross functional teams and service providers; develop and present proposed solutions and provide oversight of timely resolution in a collaborative approach.
- Preparation of updates on study status for internal and external parties
- Collaborate with data management (internal or CRO vendor) and CRAs to ensure data quality and compliance with data cleaning timelines
- Leads and/or contributes to department process improvements/initiatives and SOPs
- Provide direction and mentoring to junior team members.
- Escalate pertinent CRA performance and site compliance issues when necessary
- Bachelor's degree required, preferably in the Life Sciences or equivalent
- 5+ years relevant clinical research experience in the pharmaceutical industry, or a similar organization (e.g. CRO), including clinical trial leadership experience, Ph3 and global experience strongly preferred
- Prior leadership experience in study start-up
- Global Clinical Trial experience in Phase 2 and/or Phase 3
- Inspection readiness and inspection experience is a plus
- Exceptional attention to detail and organizational skills
- Excellent communication (oral and written), analytical, and project management skills
- Ability to develop and maintain strong, collaborative relationships with key internal and external stakeholders
- Proven ability to work independently and prioritize tasks effectively in a fast-paced, remote working environment
- Financial budgeting and forecasting skills
- In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes
- Must have established experience and fluency in the Microsoft Office package of programs (Excel, Word, Outlook, PowerPoint, SharePoint)
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Clinical Trial Manager - Boston, United States - Imbria Pharmaceuticals
Description
Company Overview
Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to symptoms and functional deficits. Our lead investigational product candidate, ninerafaxstat, has completed Phase 2 clinical trials in non-obstructive hypertrophic cardiomyopathy (nHCM), stable angina, and in patients at high risk of developing cardiometabolic heart failure with preserved ejection fraction (pre-HFpEF). In Phase 1 and 2 clinical trials, ninerafaxstat was shown to be well tolerated. Part 2 of our Phase 2 trial, IMPROVE-DiCE, in patients with cardiometabolic HFpEF, is ongoing with topline results expected in early 2025. For additional information, please visit
Position Overview
This position manages overall clinical study operations including CRO and vendor management, development of project plans, budget, and resource management. They will lead the development of study operational plans and provide input into other functional area plans and processes as needed. They will provide oversight of the CRO, vendors and sites as well as ensure compliance with GCP and regulatory guidelines. Note: This position requires the incumbent to reside in the Boston area.
Responsibilities
Qualifications
This position requires the incumbent to reside in the Boston area. We offer a competitive total compensation package and invite you to consider a career with Imbria
