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Project Manager for Clinical Trial
Chapel Hill, NC 27599 United States
Part-time Consulting position/no benefits
The Project Manager should be self-motivated with experience managing clinical projects, multi-tasking, and maintaining strong communication with stakeholders. This main objective will be to oversee an early phase clinical trial program that will be performed at two University sites to test a first in class anti-cancer agent developed by Meryx Inc. The project manager will work with executives and founders of Meryx to assure the smooth conduct, monitoring and FDA reporting of clinical trial results. In addition the project manager will work with other Meryx employees and contractors to help conduct the business endeavors of Meryx. The ability to ensure adherence to and prioritization of programs and schedules in accordance with Meryx Clinical Development Objectives will be needed. The person in this role will need to ensure that all data are collected, interpreted and communicated to Meryx leadership and ensure that reports are appropriately recorded and stored to support patents and regulatory filings. This project manager will provide a link with partner groups including university collaborators, research organizations and consultants. To be effective, the Project Manager will need to have strong interpersonal and communication skills, be flexible and be able to take initiative.
Advanced degree in a Life Sciences discipline and extensive experience with clinical trials conduct and regulatory aspects. Demonstrated capability to manage projects including adherence to and prioritization of programs and schedules, in accordance with Clinical Development Objectives.
* Provide oversight to clinical programs.
* Develop program timelines after working with executive management, to develop objectives, milestones, and scope.
* Lead regular team meetings and ensure that clear actions and decisions are documented, communicated and committed to, enabling timeline achievement.
* Highlight risks and timeline delays to executive management.
* Review and approve (when appropriate) deliverables from vendors, contractors, and academic labs.
* Map and track finances and review invoices for the project.
* Maintain frequent communication with the clinical project team members and key internal stakeholders to keep all aware of issues, contingencies, and milestones.
* Prepare summary information on program progress, timeline updates and risk assessment for periodic presentations to Meryx oversight committees.
* Oversee the development of appropriate routine reports to federal agencies.
* Oversee final report generation for the clinical trial.
* Work with regulatory advisors to interact with the FDA.
* Ensure quality control and data integrity and records of all data.
* Exhibit integrity and focus on quality; embed these principles within the organization.
* Ensure compliance of all departmental employees with all appropriate ethics codes, standards and training, and safety training and practice.
North Carolina Biotechnology Center