Clinical Trial Manager
Avidity Biosciences is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies in order to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies in order to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. We are passionate about the impact of every employee in bringing these potentially transformative therapeutics to patients in need. Make a difference with us.Job Summary
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.Essential Duties and Responsibilities
- Performs job with minimal supervision
- Develop and manage study level timelines and budgets in accordance with corporate, department, and project goals, working closely with internal leadership and CROs
- Establish key deliverables and KPIs in management of CRO and vendors
- Communicate to internal leadership on progress and issues, including dashboards and reporting
- Acts as the clinical operations representative in variety of cross-functional teams
- Management of the study level budget and tracking against budget with all parties
- Manage study activities including investigator selection, drug supply projections, study start-up, subject recruitment & retention, data collection, and database locks/study closeout.
- Actively contribute to technical and study design discussions, providing input toward clinical trial outlines, protocols, informed consent forms, clinical study reports.
- Lead functional team members to draft/revise, finalize, and implement project plans, study-specific training, system builds, CRF designs, UATs.
- 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.
- Participate and present at investigator meetings and ability to lead site qualification, initiation, oversight/co-monitoring, and closeout visits.
- Leads and/or contributes to department process improvements/initiatives and SOPs
- Provide direction and mentoring to junior team members
- Bachelor’s degree required, preferably in the Life Sciences or equivalent
- Minimum of 5+ years of experience in clinical operations is required
- Experience managing a CRO as well as a complex study in a previous Clinical Trial Manager (or equivalent) position is required
- Global Clinical Trial experience in Phase 2 and/or Phase 3
- Experience in Rare Disease or Neuromuscular drug development is a plus
- 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
- Ability to multi-task well, to deal well with conflict and obstacles, and to work in a fast-paced environment
- Financial budgeting and forecasting skills
- In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes