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Oncorus Associate Clinical Trial Manager in Cambridge, Massachusetts

About Oncorus:

Oncorus is a clinical-stage biotechnology company focused on developing next-generation viral immunotherapies to transform outcomes for cancer patients. Based in the vibrant Kendall Square, MA biotech ecosystem and backed by group of leading institutional life sciences investors, we are advancing a portfolio of intratumorally and intravenously administered viral immunotherapy candidates based on our oncolytic herpes simplex virus-1 and synthetic virus platforms for multiple indications with significant unmet needs. Our team is driving innovation and engineering multiple candidates with both platforms to potentially enable us to deliver on the full potential of this exciting therapeutic class. We believe every cancer patient deserves a better outcome. And we?re working with urgency to make that happen. Please visit www.oncorus.com to learn more.

Position Description:

We are seeking a highly motivated Associate Clinical Trial Manager to support the ongoing clinical development portfolio at Oncorus. Reporting to the Associate Director, Clinical Operations, this candidate will be responsible for the planning, implementation, and execution of clinical study protocols, operational plans, and study timelines. This individual should have strong organizational skills, vendor management skills and strong knowledge of FDA regulations and GCP/ICH guidelines.

Duties And Responsibilities:

  • Manages all aspects of clinical study progress (from protocol development and planning to study close-out, including supporting the development of clinical study reports)

  • Ensures adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, GCP, and ICH guidelines

  • Communicates with clinical trial sites as appropriate to ensure best possible Sponsor-Site relationships

  • In partnership with the clinical study team, ensures trial compliance in accordance with regulations and SOPs

  • Demonstrates the ability to recognize the need to seek assistance from or inform Senior Management of specific clinical trial risks/issues

  • Analyzes clinical study and investigative site risks and implements corrective actions, where required

  • Manages the clinical study budget, including management of CRO and vendor work orders

  • Coordinates the development of clinical study documents, including informed consent forms, operational documents, study reference documents, study newsletters, site materials, and other study related documents

  • Supports the development of clinical study protocols, clinical study reports and other documents as needed

  • Communicates trial status within and outside the study team to ensure cross-functional alignment of expectations, priorities, and deliverables

  • Manages relationships with CROs and other vendors as well as study site staff and internal team members

  • Participates in departmental initiatives such as the development and review of SOPs and work instructions

  • Perform other related duties and ad-hoc projects as required

Required Education, Skills and Experience

  • Bachelor?s degree required, life science or health-related field is preferred

  • 4+ years of relevant clinical research experience gained with a CRO, biotech, or pharmaceutical company. Oncology experience preferred

  • Working knowledge of clinical trial management activities in an outsourced CRO model

  • Deep knowledge of GCP, ICH, and FDA guidelines

  • Experienced in project management and vendor management

  • A motivated leader, with a passion for bringing new treatments to patients who need them

  • A strong communicator, with the ability to work in a fast-paced and team-oriented environment

  • Effective team player ? puts personal agenda aside and focuses on what?s best for our patients and the team

  • Able to deal with pressure, take on challenging projects, manage competing priorities, and anticipate problems in advance

Benefits and Perks

  • Oncorus, Inc. is an Equal Opportunity Employer, and offers a comprehensive benefits package including health, dental, life insurance, 401k, unlimited vacation and much more.

  • Job Type: Full-time

  • Travel: up to 25% of time

  • Salary: commensurate with role and experience

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