A leading biotechnology company is seeking a Clinical Trials Manager to join their team. With a focus on cutting-edge cell and gene therapies, this role offers the opportunity to contribute to groundbreaking treatments and technologies.
Job Detail
Job Description
Key Responsibilities:
- Maintain accurate and up-to-date site, vendor and internal study team contact information.
- Assist with study start-up of clinical trials, including feasibility, investigator recruitment, collection of regulatory documents and general site management support.
- Communicate directly with sites to drive collection of essential documents from start-up through study closure.
- In collaboration with the study team, identify risks to study and assist in developing risk mitigation plans, including communication with management when necessary.
- Review monitoring reports and monitoring visit letters to assess trends and site performance.
- Initiate and/or contribute to the creation and maintenance of documents and plans for assigned clinical studies including but not limited to training materials, plans, operating manuals, presentations, and reports.
- Support the study team in creating and implementing study-specific tools to ensure clean data and timely data entry and may assist in clinical data review and resolution of queries as needed.
- Participate in and manage study team meetings and meetings with CROs, vendors, and multi-functional teams and prepare meeting agendas, minutes, and track action items.
- Manage performance of field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Clinical Operations Management.
- Assist with CRA and third-party vendor training on protocols and practices.
- Maintain study tracking including regulatory Q&A, site start-up regulatory timeline, protocol issue tracker, and other study tracking as appropriate.
- In collaboration with the CRO and the study lead(s), establish and maintain the Trial Master File in inspection-ready state.
- Perform and support QC reviews of study, country and site files, including issue resolution.
- May conduct Pre-Study Visits and Site Initiation Visits.
- Support preparing submissions and obtaining approval from local Health Authorities and Ethics Committees.
- Assist with Investigational Product inventory, tracking and shipping to clinical sites and reconciliation.
- Support the negotiations and management of the site budgets and the review of clinical site invoices, in collaboration with the study lead(s) and/or VP, Clinical Operations or designee.
- Track and report on progress of study including but not limited to site activation, patient enrollment, monitoring visits.
- Lead or participate in functional initiatives and/or activities as assigned.
Requirements and Desired Experience:
- Bachelor's degree in life sciences, nursing, pharmacy, or related field; advanced degree preferred.
- Minimum of 4 years of experience as a Clinical Trial Manager, with significant experience in Phase I-II clinical trials within the Autoimmune therapeutic area.
- Demonstrated expertise in Cell & Gene Therapy trials is highly desired.
- Strong understanding of GCP, FDA, and ICH guidelines, regulations, and compliance requirements.
- Proven ability to manage multiple tasks, prioritize workload effectively, and meet deadlines in a fast-paced environment.
- Excellent interpersonal, communication, and organizational skills.
- Ability to travel domestically and internationally, as required, up to 50%.
- Certification as a Clinical Research Professional (CCRP) or equivalent is a plus.
- Proficiency in Microsoft Office Suite and familiarity with electronic data capture (EDC) systems.
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