We are seeking application from qualified candidates for the position of “Clinical Program Manager” for our Princeton, NJ location.
- Graduate or Post Graduate in Science or Business.
- Minimum 8-10 years of experience in the Pharmaceutical, CRO, or Health care sectors in a project management or leadership role.
- Computer knowledge.
- Knowledgeable in project management principles and best practices
- Knowledge of Regulatory Compliance requirements
- Extensive knowledge of Data Management tools handling Case Report Forms and Patient Data
- Strong Knowledge of SAS
- Strong communication, interpersonal skills and attention to details
- Organized and proactive approach to work
- Ability to work independently as well as manage cross functional teams
- Good knowledge of departmental procedures and processes
- Act as a Subject Matter Expert on assigned projects in the area of Clinical Research and provide technical guidance to both internal and external clients.
- Maintain records of study activity, oversee subject enrollment and monitor study activity to ensure compliance with protocol
- Serve as backup point of contact on projects where the assigned Project Manager (PM) is unavailable due to business hours, closure or when the PM is away from office due to illness or vacation.
- Review weekly PM reports and help provide guidance to the PMs on study management, risk mitigation, and client management. Keep the team abreast of impending risks to the projects if any.
- Generate and Review High Level Timelines and identify deliverables that are at risk of falling behind. Work with the Project Team to ensure timely delivery of the deliverables.
- Shall be involved in the initial development of timelines for projects that are in bid and/or newly awarded.
- Work with clients and assigned PMs to define protocol deviation handling requirements and specifications for projects.
- Conference Calls
- Join client conference calls during the start-up phase of projects that require additional technical expertise to help ensure successful planning.
- Join weekly client conference calls as needed during the maintenance and closeout phases of a project.
- Shall serve as next point of issue escalation when PMs encounter an issue(s) with their assigned projects.
- Monitor study activities to ensure the studies are in compliance with the protocols.
All the above activities are to be performed in accordance with GCP, ICH guidelines, Standard SOP and study documentation.
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