Clinical Trial Manager (CTM)

OVERVIEW: Based remotely, and reporting to the Clinical Program Director, 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 Clinical Project Manager (CPM) to manage and oversee clinical site management and monitoring for Genprex sponsored trials to ensure activities are conducted, recorded, and reported in accordance with the trial protocols, Genprex standard operating procedures (SOPs), ICH-GCP, and all applicable local and federal regulatory requirements. The CTM may also assist the CPM with other trial management tasks as assigned.

JOB RESPONSIBILITIES: Ø Serve as line manager to both contract and employee Clinical Research Associates (CRAs). Responsibilities include, but are not limited to: · Conducting/Overseeing onboarding activities for new team members.· Ensuring department training compliance is maintained for direct reports.· Reviewing and approving time sheets as necessary.· Managing CRA trial/site assignments.· Providing mentoring and career development support to direct reports.· Serving as back-up during team member absence.Ø Develop and maintain the Clinical Monitoring Plan (CMP) and managing the team’s activities to ensure compliance with the metrics and guidelines provided within the plan.Ø Coordinate and manage the Clinical Monitoring Team’s (CMT) daily operations throughout the course of trials and oversee clinical monitoring activities. This includes but is not limited to:· Setting and enforcing timelines.· Defining and implementing functional standards, goals and expectations with the team.· Tracking monitoring visits for compliance, efficiency, quality and ensure monitoring activities; frequency and duration are in line with trial progress.· Reviewing and approving monitoring reports and letters within the required timeframe.· Planning and conducting productive, effective and efficient team meetings.· Developing training materials and conduct training for CMT.§ Ensuring that trial training documentation is completed and CMT training compliance is maintained.· Completing co-monitoring and oversight monitoring visit as necessary.· Identifying and managing or escalating issues to CPM in a timely manner.Ø Coordinate and manage clinical site management activities throughout the course of the trial. This includes but is not limited to:· Completing trial level Central Institutional Review Board (IRB) submissions.§ Tracking Central and Local submissions and approvals.§ Reviewing and approving site ICFs for IRB submission.· Overseeing Institutional Biosafety Committee (IBC) submission/approvals and compliance.§ Tracking IBC submissions and approvals.· Reviewing and tracking regulatory documents.· Tracking and identifying trends in site recruitment and enrollment.· Tracking and identifying trends in site performance (data entry, system compliance, action items, deviations, etc.).· Preparing training materials and conducting clinical site training.· Identifying issues and implementing corrective and preventative actions as necessary.Ø Serve as CRA back-up or as necessary, complete clinical site management activities and clinical monitoring in place of a CRA.Ø Prepare for and actively participate in meetings.Ø Develop/Review trial documents, forms, logs, templates, etc. in coordination with CPMØ Assist with internal and external trial system setup, User Acceptance Testing (UAT) and maintenance.Ø Assist with the development and implementation of the Trial Master File Plan and Trial Master File setup, maintenance and archive.Ø Assist in risk assessment, management and mitigation activities.Ø Perform other duties assigned by the CPM or department management.

QUALIFICATIONS: Ø B.S./B.A. in a scientific or health related fieldØ Minimum 5 years’ industry experience with 2+ years Lead CRA or CTM experience with pharmaceutical/biotech company or CRO Ø Prior oncology experience requiredØ Prior experience with CTMS, EMR, EDC, eTMF, IRS/RTSM preferredØ Travel up to 25% of the time domestically (fly and/or drive) and internationally to attend SIVs, co-monitoring visits, monitoring oversight visits, team meetings, etc. Ø Must have suitable environment for home-based employmentØ Valid driver’s license and passportØ Adequate computer skills to complete job responsibilities including proficiency with Microsoft Office applicationsØ Must have and demonstrate:· Excellent written and verbal communication skills · Strong organizational skills· Attention to detail· Ability to work both in a team and independently· Ability to effectively manage a team· Ability to train and mentor co-workers and teammates· Ability to work on multiple trials completing multiple tasks at once while maintaining high quality and productivity standards· Ability to prioritize and execute tasks/assignments on time with high-quality results· Ability to remain flexible and adaptable in a wide range of scenarios· Good presentation skillsØ In-depth working knowledge and understanding of clinical trial processes and activitiesØ Thorough working knowledge and understanding of current regulatory and ICH-GCP guidelinesGenprex is committed to providing an environment of mutual respect where equal opportunity and diversity are embraced and recognized as crucial to our success. We welcome diverse backgrounds, perspectives, and skills in our workforce and our culture.