Clinical Project Manager
Personal Genome Diagnostics is seeking a Clinical Project Manager. The Clinical Project Manager plays an important role in tracking and completion of studies within the Clinical and Research Services team at PGDx. The Clinical Project Manager position will perform a wide variety of activities to support the startup and completion of clinical trials and RUO studies at PGDx.
- Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts
- Tracks study timelines, budget, and quality metrics
- Works in collaboration with the Study Leads to ensures appropriate clinical resources are available for the project
- Ensures GCP and regulatory compliance is maintained
- Works in collaboration with the Study Leads to develop the study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
- Maintains professional expertise through familiarity with therapeutic area and clinical research literature
- Helps in organizing regularly scheduled cross-functional study team meetings with internal and external resources
- Participates in meetings with investigative sites, key opinion leaders and consultants as needed
- Plays a part in the analysis, summary, and reporting of clinical or research data through the course of the study
- Report on the progress of assigned clinical trials and RUO studies, which includes budgets and timelines
- Aides in the training and development of all clinical staff members
- Performs other duties as assigned
- Proactively identifies and resolves issues, and participates in process improvement initiatives as required
- Responds promptly and appropriately to study questions and issues raised by investigative sites, vendors, monitors, and consultants
REQUIRED EDUCATION AND EXPERIENCE
- 3-5 years clinical research experience in an industry setting and a minimum of 2 years project-lead or management experience.
- A Bachelor’s and/or Master’s degree in any science or health related field
- Knowledge of NGS preferred
- CRA certification (ACRP or equivalent) is strongly preferred
- Excellent organizational, leadership and problem-solving skills
- Excellent written and verbal communication skills
- Know-how in managing Phase I, II, & III clinical studies preferred
- Experience in writing clinical study protocols, informed consent forms, and other clinical documents preferred
- Proficient computer skills, specifically with Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
- Solid understanding of FDA and other regulatory requirements that may impact global clinical studies
- Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
- Willing and capable to manage multiple projects
- Working knowledge of MS Project for development and update of clinical study timelines
ABOUT PERSONAL GENOME DIAGNOSTICS
Personal Genome Diagnostics (PGDx) empowers the fight against cancer by unlocking actionable information
from the genome. We are committed to developing a portfolio of regulated tissue-based and liquid biopsy
genomic products for laboratories worldwide. PGDx was established by internationally-recognized cancer
researchers Dr. Luis Diaz and Dr. Victor Velculescu, who are pioneers in the application of innovative genomic
technologies for drug development and clinical practice.
Please submit applications (cover letter and resume) to HR@personalgenome.com
Special consideration will be given to internal PGDx employees who apply.
APPLY FOR JOB