Based remotely, and reporting to the Director, Clinical Trials, the Clinical Trial Manager (CTM) will work with internal and external team members in a collaborative, productive and quality driven setting to help ensure the successful execution of all clinical trials sponsored by Genprex. The CTM will work closely with the assigned project manager to manage and oversee investigational site management and monitoring for assigned trials to ensure the activities are conducted, recorded, and reported in accordance with the protocol, Genprex standard operating procedures (SOPs), ICH-GCP, and all applicable local and federal regulatory requirements. The CTM may also assist the project manager with other trial management tasks as assigned.
- Ensure all activities related to implementation and execution of investigational site management and clinical monitoring are conducted in compliance with the protocol, study manuals and plans, applicable SOPs, and applicable regulatory requirements and guidelines.
- Work with project manager to define monitoring requirements, metrics, and staffing.
- Complete CTMS setup as applicable.
- Develop, implement and maintain Monitoring Plan.
- Assist with the development and implementation of the Trial Master File Plan and Trial Master File setup, maintenance and archive.
- Complete trial level IRB submissions as applicable
- Develop/Review trial plans, documents, forms, logs, etc. as necessary.
- Manage investigational site invoicing and payment tracking per the CTA and applicable processes and procedures.
- Assist in risk assessment, management and mitigation activities for trial.
- Assist with vendor activities for trial upon request.
- Coordinate and manage trial’s clinical monitoring team’s daily operations throughout course of trial and oversee clinical monitoring activities. This includes but is not limited to:
o Set and enforce timelines.
o Define and implement functional standards, goals and expectations with team.
o Track monitoring visits for compliance, efficiency, quality and ensure monitoring activities, frequency and duration are in line with trial progress.
o Review and approve monitoring reports and letters within the required timeframe.
o Plan and conduct productive, effective and efficient team meetings.
o Develop training materials and conduct training for clinical monitoring team.
o Complete co-monitoring as necessary
o Identify and manage or escalate issues to project manager in a timely manner.
- Coordinate and manage investigational site management activities for trial from start-up through close-out. This includes but is not limited to:
o Regulatory document tracking and review
o Tracking and identifying trends in site recruitment and enrollment
o Tracking and identifying trends in site performance (data entry, system compliance, action items, deviations, etc.)
o Prepare training materials and conduct investigational site training.
o Identify issues and implementing corrective and preventative actions as necessary.
- Serve as CRA back-up or as necessary, complete investigational site management activities and clinical monitoring in place of a CRA.
- Provide training and mentoring to CRAs and junior level CTMs.
- Prepare for and actively participate in meetings.
- Perform other duties as assigned by the project manager or department management.
- B.S./B.A. in a scientific or health related field
- Minimum 4 years industry experience with 2+ years Lead CRA or CTM experience with pharmaceutical/biotech company
- 2+ years site monitoring experience and willingness to independently conduct monitoring visits
- Prior oncology experience preferred
- Prior experience with CTMS, EMR, EDC, eTMF, IRS preferred
- Must be able to travel up to 50% of the time domestically (fly and/or drive) and internationally
- Must have suitable environment for home-based employment
- Must have valid driver’s license and passport
- Must have adequate computer skills to complete job responsibilities including proficiency with Microsoft Office applications
- Must have and demonstrate:
o Excellent written and verbal communication skills in English
o Strong organizational skills
o Attention to detail
o Ability to work both in a team and independently
o Ability to effectively manage a team
o Ability to train and mentor co-workers and teammates
o Ability to work on multiple trials completing multiple tasks at once while maintaining high quality and productivity standards
o Ability to prioritize and execute tasks/assignments on-time with high quality results
o Ability to remain flexible and adaptable in a wide range of scenarios
o Good presentation skills
- Must have in-depth working knowledge and understanding of clinical trial processes and activities
- Must have thorough working knowledge and understanding of current regulatory and ICH-GCP guidelines