Clinical Project Manager I Vacancies in Cerner Corporation New York, NY
Website Cerner Corporation
This Jobsfunter Listing is about Cerner Corporation in New York, NY 2022
About the job
Cerner Enviza is seeking a Clinical Project Manager I who is responsible for all activities of site and project management associated with observational non-interventional studies (NIS, Phase IV).
Responsibilities includes site support and project management in accordance with relevant SOPs, study specific procedures and regulations. Responsible for protocol expertise with accountability for quality and timelines, as well as other tasks as assigned by supervisor. This position reports to the Senior Director within the Non-Interventional Studies (NIS) Research group.
- Conducts activities to ensure adherence to scope of work, timelines and budget for assigned projects
- Schedules weekly team meetings and produces minutes and action plans
- Reviews and coordinates internal project team and external vendor project deliverables, ensuring standard processes are followed. Ensures deliverables are met on time and with appropriate quality
- Assists with site identification and selection
- Creates study & site training materials, and participates in on-site or remote site initiation trainings as needed
- Proactively identifies project issues and works with Senior Director and team members to define mitigation strategy and approach
- May be responsible for negotiation of site agreements, budgets, and customization of site informed consent
- Defines IRB/EC submission components and supports approval process
- Collects, reviews, and files regulatory documents for IRB/EC and RA submissions, including ongoing study maintenance (i.e., yearly renewals, etc.)
- Oversees site management and monitoring, including review and resolution of EDC data queries
- Participates in the development and review of accompanying study materials (e.g., questionnaires, informed consent forms, etc.)
- Ensures appropriate project documentation is maintained, including Trial Master File content and maintenance. Ensures materials are saved in shared folders in compliance with SOP
- Plans, develops agenda and materials, and works with outside parties as appropriate (e.g., event planner, venue) for investigator meetings
- May assist in preparation of proposals, including pricing and scoping of external components (i.e., validated scales, vendor costs)
- Attends and presents as main client contact during proposal and/or bid defense meetings to gain awarded work
- Designated as the direct point of contact for client
- Prepares status reports to client as well as internal parties on a regular basis
- Updates Senior Director regularly on project progress, and escalates issues as needed
- Manages communication with internal teams such as Finance, Engagement Services, etc. regarding project status, deliverables, etc.
- Assists in the management of contractual and financial aspects of assigned projects, including managing within study budgets and scope of work. May include working with contractors and vendors
- Supports internal and client financial tracking and reporting, including revenue recognition forecasting, expense management and client invoicing
Cerner Enviza is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Cerner Enviza, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research. Cerner Enviza is passionate about our people, our business, and our clients and is proud to foster a culture that contributes to the health and well-being of humankind. Leading through innovation, we consistently challenge ourselves to discover and embrace new and creative ways to deliver exceptional insight for clients.
Qualifications Basic Qualifications :
- At least 4 years total combined related work experience and completed higher education.
- Bachelor’s degree in Biology, Life Sciences, Social Sciences, Business Administration or related field.
- At least 2 years’ experience as a Clinical Research Associate (CRA) in one or more therapeutic areas is desired
- Non-interventional (Phase IV) experience desired.
- Lead Clinical Research Associate experience desired.
- Knowledge of medical/pharmaceutical terminology, experience and/or coursework in conducting non-interventional and/or clinical studies or clinical experience with knowledge of one or more therapeutic areas.
Company: Cerner Corporation
Vacancy Type: Full-time · Associate
Job Location: New York, NY
Application Deadline: N/A