The Clinical Trial Manager is responsible for planning, executing and reporting of a clinical trial(s) according to Abeona standard operating procedures, ICH-GCP and regulatory requirements. This includes writing and/or reviewing the protocol, informed consent form and other trial documents, Investigator identification and selection, vendor selection and management, data review and trial close-out for one or more phase I-IV global clinical trial.
This position is key to good communication and professional relationships with Investigators, site staff, international colleagues in HQs and Affiliates, and CROs. It is the single point of contact within clinical operation for the project team.
Responsible for the clinical operation activities from trial start up to close out
- Drives Investigator identification and selection
- Development of trial documentation (e.g. protocol, monitoring plan, manuals, trial document templates)
- Coordinates preparation of essential documents and IRB/EC/IBC submission packages
- Ensure on-time trial start by monitoring the status of or initiating clinical trial supply delivery, provide trial training as needed, and any other activities that support site readiness.
- Ensures overall completeness of the Abeona Trial Master File to remain inspection ready.
- Plans and conduct local and global investigator meetings, as needed.
- Leads clinical trial team meetings. Reports trial status to the project team.
- Oversees CRO and vendor selection and performance.
- Serves as main contact for any potentially significant quality/compliance issues and escalate to clinical trial team as required.
- Maintains a strong knowledge of the protocol to be able to answer standard questions from CRO, vendors, monitors, and sites.
- Recognizes potential challenges within the protocol and operational aspects of the trial and resolve or escalate, as appropriate.
- Responsible for the trial enrolment globally. Assist in setting up contingency plans to ensure enrolment targets are achieved
- Ensures all operational aspects are on schedule. Oversees clinical trial team activities to achieve trial timelines and quality execution according to Abeona standards and local and international regulations.
- Oversees CRO and vendor activities and deliverables ensuring quality and rapid issue escalation and resolution as needed.
- Reviews monitoring visit reports to identify trends/issues. Appropriately escalate issues in a timely manner and ensure resolution. Communicate with monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics.
- Accountable for coordinating data management activities, ensure timely data entry, data quality and data issue resolution.
- Reviews data listings (including lab values, screen failures, discontinuations rates), patient profiles, and protocol deviations.
- Facilitates internal audits and Health Authority inspections as required. Assist in the implementation of corrective actions following audits and inspections.
- Ensures that all trial close–out activities are performed, in close cooperation with field monitors and clinical trial team/CRO.
Bachelor’s degree in life sciences or healthcare. Master’s degree preferred.
- 3-5+ years of clinical research experience including 2+ years within clinical trial management
- Rare disease and/or gene therapy experience (preferred)
- Experience in a role overseeing global clinical studies
- Ability to work in a global environment at a fast pace and manage multiple complex projects
Personal skills & abilities
- Excellent analytical, verbal, and written communication skills.
- Strong organizational and time management skills.
- Quality oriented with attention to details.
- Highly proactive, self-motivated, professional and dedicated.
- Demonstrated computer skills (MS Office, MS Project, EDC, IXRS, eTMF, and CTMS preferred).
- Ability to drive and willingness to travel for study related meetings, monitoring and auditing visits, as needed.
The level of this position will be based on the final candidate’s qualifications.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.