Description: The main responsibility is to assist in the clinical implementation and execution of Abeona’s clinical studies in accordance with GCP, ICH, FDA, and international regulations as appropriate to ensure the quality and integrity of data. The Sr. / Clinical Study Manager is responsible for planning, executing, and reporting of a clinical study(ies). This includes the preparation of all study documentation, site, and vendor selection, set up of procedures, study monitoring and oversight, by serving as study lead. During study conduct, be familiar with clinical trial patients, data, adverse events, reports, TMF, etc. to effectively communicate trial status to the Head of Clinical Operations as the single point of contact for their study(ies). May assist with preparation of INDs, investigator brochures, annual reports, integrated medical reports and other worldwide regulatory submissions, as necessary.

Responsibilities:

Coordinates the preparation / updates of all essential documentation (e.g., clinical protocol, investigational brochure, patient documentation, etc.).
Create or assist in the development of study documents such as Case Report Form, Plans (monitoring, project management, communication, recruitment, safety, data) and Manuals (laboratory, pharmacy, recruitment, etc.).
Responsible for all aspects of clinical study start-up including identification, evaluation and management of sites and vendors.
Facilitates communication / logistics between internal and external team members to ensure current program status to ensure priorities are on track with study goals and objectives continue to be aligned with corporate expectations.
Responsible for coordination of the logistics and investigational medicinal product accountability with Abeona CMC team and vendors.
Oversees vendor activities and deliverables ensuring quality and rapid issue escalation as needed. Review vendor documentation such as monitoring visit reports, minutes, plans, manuals to identify trends/issues.
Serves as main contact keeping track of study recruitment (pre-screening and screening activities) across the sites and referrals between sites.
Communicate overall study status to project and senior management of any issues that may impact timelines, personnel, budget needs, patient safety, and quality of data. Identify risks to clinical trial execution and develop risk mitigation strategies.
Recognize potential challenges within the protocol and operational aspects of the trial and resolve or escalate, as appropriate. Serves as main contact for any potential quality / compliance issues and escalate as required.
Ensures overall completeness of the Abeona Trial Master File to remain inspection ready.
Facilitated contractual and budget negotiations with investigators and vendors. Includes main sponsor contact for vendors and internal financial team reviewing trial invoices for initial approval to ensures each clinical trial is conducted withing the defined budget.
Facilitates internal audits, CAPAs and Health Authority inspections as required. Assist in the implementation of corrective actions following CAPAs, audits and inspections.
Serves as back up for other clinical studies when there is an internal need.

Experience and Skills: The successful candidate must have strong communication, interpersonal and organizational skills; must have the ability to function independently, be flexible, detail oriented, and work effectively on a team with a high degree of professionalism. Previous management experience is required. The ideal candidate will have a strong working knowledge of the clinical trial process as well as GCP, ICH and FDA regulations and guidelines of clinical trials. A working understanding of the drug development / gene cell therapy process is desired. The candidate must be able to work effectively in a fast-paced environment and balance multiple priorities in a timely manner. Must have experience in effectively troubleshooting and resolving clinical issues. Demonstrated computer skills (MS Office, MS Project, EDC, IXRS, eTMF, and CTMS preferred).

Requirements: University/college degree (BS/BA/MS) or certification in a related health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) required. Strong word processing and computer (Word, Excel, Power-Point, etc.) skills are a must. Management experience with 3-5 years experience is required in clinical research, including 2-3 years of clinical monitoring. Prior gene cell therapy and Rare disease experience is desired, but not necessary. The candidate must have the ability to lift and move 40 pounds. An active and valid driver’s license and passport are required. Travel up to 35%, domestic and international.

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Abeona Therapeutics

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