Clinical Project Manager
Clinical Project Manager (Vyriad Inc. )
Vyriad is a clinical-stage, privately held biotechnology company based in Rochester (MN), focused on the development of powerful first-in class oncolytic virotherapies. (www.vyriad.com) Our Oncolytic virotherapy platforms utilize bioengineered virotherapies designed to selectively and rapidly destroy cancer, with the aim to potentially create “a single shot to cure cancer”. We have exclusively licensed the Vesicular Stomatitis Virus (VSV) and Measles Virus (MV) Oncolytic platforms, originally developed in the laboratories of our founders Drs Stephen Russell and Kah Whye Peng at Mayo Clinic and Dr Glen Barber at University of Miami.
Vyriad maintains a vibrant and transformative oncolytic virotherapy pipeline by continuously creating and testing cancer-fighting viruses engineered in different ways, and combined with various drugs, to destroy cancer cells directly as well as harness and enhance the body’s natural tumor-killing immune responses
The Clinical Project Manager (CPM) is responsible for the execution of the clinical development programs (Voyager-V1) overseeing key activities from protocol design to the final clinical study report and applies best practices in the development, initiation, planning, execution, control and completion of the clinical studies. The CPM coordinates the activities of functional groups that comprise the project team, in a matrix management structure, to ensure proper conduct and timely completion of all projects. The CPM is responsible for coordinating efforts for the management of the clinical development programs both within the Company and through a variety of vendors, whereby the ability to effective ongoing communication of the clinical development activities is critical.
- Plan, initiate and execute clinical studies while adhering to budget, scope and schedule requirements.
- Participate in creation and/or review of all supporting documents for a clinical study – Protocols, Statistical Analysis Plans, CRFs, Data Management Plans, Clinical Study Reports, etc.to ensure seamless integration between clinical objectives and study performance.
- Develop and effectively manage budgets, timelines, and resources for assigned clinical studies and escalate variances within the established processes.
- Develop study plans and lead system set-up.
- Adheres to standards and processes in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
- Manage and lead clinical development program teams, including vendors.
- Ensure training of internal and external team members on appropriate SOPs and processes and effective training of study team, study sites and vendors of assigned clinical studies.
- Responsible for up to date study and/or program information and provide management with routine updates regarding the status of ongoing studies.
- Proactively identify and resolve issues and manage escalation as appropriate.
- Participate in CRO review, selection, and negotiation for clinical studies.
- Develops and maintains relationships with external vendors and/or consultants and contractors.
- Participate in the development and implementation of clinical operations standard operating procedures and common work practices within the team.
- Must be willing to travel up to 20%.
Experience and Qualifications
- BA/BS degree preferably in science, nursing or related areas with at least 3 years of experience in clinical research operations of which 2 years must be direct study management experience in the pharmaceutical or biotech industry
- Experience in managing all stages of study conduct (start-up, maintenance and completion).
- Experience in oncology is highly desirable
- Must be hands on and used to a start-up environment
- Knowledge of GCP and ICH guidelines required
- Demonstrated track record in the oversight of all trial operational aspects including: budgets, timelines, resources, vendor selection and management, oversight of clinical team staff during study start-up, interim monitoring and closeout activities
- Proficiency in the implementation, monitoring, and management of clinical trials
- Able to work collegially within a team and carry out duties/responsibilities with general instructions