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Clinical Trial Manager

Employer
Avidity Biosciences
Location
San Diego, CA, United States
Start date
Feb 19, 2021

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Discipline
Clinical, Clinical Trials
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach
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Job Details

Company Overview

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

Qualifications
  • 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

Company

avidity banner

Our vision is to profoundly improve people’s lives by revolutionizing the delivery of RNA therapeutics. We’re utilizing our proprietary AOC platform to design, engineer, and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) with the precision of oligonucleotide-based therapies in order to redefine RNA therapeutics and more effectively target underlying genetic drivers of diseases. We are delivering on this vision by investing in our platform, our pipeline and our people.

Our commitment to rigorous and innovative science is matched only by our passion to see patients’ lives changed. We consistently challenge ourselves to Be AVID – Agile, Visionary, Integrated and Diverse.

We are assembling a diverse team experienced in rare disease and RNA therapies. Our team members bring expertise in research, development and commercial execution. We are focused on cultivating the right team to not only grow the company, but also to reflect the communities we serve. We are dedicated to employing and retaining a diverse and inclusive workforce at all levels of the organization to not only ensure that different backgrounds and perspectives are being heard and acted upon, but that our employees also feel understood, accepted and valued.

 

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avidity team 3 avidty team 2

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Company info
Website
Phone
858-401-7900
Location
10578 Science Center Drive
Suite 125
 San Diego
California
92121
US
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